[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Rules and Regulations]
[Pages 69404-70700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23873]
[[Page 69403]]
Vol. 87
Friday,
No. 222
November 18, 2022
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare and Medicaid Programs; CY 2023 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Implementing
Requirements for Manufacturers of Certain Single-dose Container or
Single-use Package Drugs To Provide Refunds With Respect to Discarded
Amounts; and COVID-19 Interim Final Rules; Final and Interim Final
Rules
Federal Register / Vol. 87 , No. 222 / Friday, November 18, 2022 /
Rules and Regulations
[[Page 69404]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 423, 424, 425, and 455
[CMS-1770-F, CMS-1751-F2, CMS-1744-F2, CMS-5531-IFC]
RINs 0938-AU81, 0938-AU95, 0938-AU31, 0938-AU32
Medicare and Medicaid Programs; CY 2023 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Implementing Requirements for Manufacturers of Certain Single-dose
Container or Single-use Package Drugs To Provide Refunds With Respect
to Discarded Amounts; and COVID-19 Interim Final Rules
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule and interim final rules.
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SUMMARY: This major final rule addresses: changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
Medicare Shared Savings Program requirements; updates to the Quality
Payment Program; Medicare coverage of opioid use disorder services
furnished by opioid treatment programs; updates to certain Medicare and
Medicaid provider enrollment policies, including for skilled nursing
facilities; updates to conditions of payment for DMEPOS suppliers;
HCPCS Level II coding and payment for wound care management products;
electronic prescribing for controlled substances for a covered Part D
drug under a prescription drug plan or an MA-PD plan under the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act);
updates to the Medicare Ground Ambulance Data Collection System;
provisions under the Infrastructure Investment and Jobs Act; and
finalizes the CY 2022 Methadone Payment Exception for Opioid Treatment
Programs IFC. We are also finalizing, as implemented, a few provisions
included in the COVID-19 interim final rules with comment period.
DATES: These regulations are effective on January 1, 2023.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not identified
below. Please indicate the specific issue in the subject line of the
email.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and PFS specialty-specific
impacts.
Kris Corwin, (410) 786-8864, for issues related to the comment
solicitation on strategies for updates to practice expense data
collection and methodology.
Sarah Leipnik, (410) 786-3933, and Anne Blackfield, (410) 786-8518,
for issues related to the comment solicitation on strategies for
improving global surgical package valuation.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to telehealth services
and other services involving communications technology.
Regina Walker-Wren, (410) 786-9160, for issues related to nurse
practitioner and clinical nurse specialist certification by the Nurse
Portfolio Credentialing Center (NPCC).
Lindsey Baldwin, (410) 786-1694, or
[email protected], for issues related to PFS
payment for behavioral health services.
[email protected], for issues related to PFS
payment for evaluation and management services.
Geri Mondowney, (410) 786-1172, Morgan Kitzmiller, (410) 786-1623,
Julie Rauch, (410) 786-8932, and Tamika Brock, (312) 886-7904, for
issues related to malpractice RVUs and geographic practice cost indices
(GPCIs).
[email protected], for issues related to
non-face-to-face nonphysician services/remote therapeutic monitoring
services (RTM).
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to payment
of skin substitutes.
Pamela West, (410) 786-2302, for issues related to revisions to
regulations to allow audiologists to furnish diagnostic tests, as
appropriate without a physician order.
Emily Forrest, (410) 786-8011, Laura Ashbaugh, (410) 786-1113, Anne
Blackfield, (410) 786-8518, and Erick Carrera, (410) 786-8949, for
issues related to PFS payment for dental services.
Heidi Oumarou, (410) 786-7942, for issues related to the rebasing
and revising of the Medicare Economic Index (MEI).
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to requiring
manufacturers of certain single-dose container or single-use package
drugs payable under Medicare Part B to provide refunds with respect to
discarded amounts.
Laura Ashbaugh, (410) 786-1113, and Rasheeda Arthur, (410) 786-
3434, for issues related to Clinical Laboratory Fee Schedule.
Lisa Parker, (410) 786-4949, or [email protected], for issues
related to FQHCs.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHCs.
Daniel Feller, (410) 786-6913, and Elizabeth Truong (410) 786-6005,
for issues related to coverage of colorectal cancer screening.
Heather Hostetler, (410) 786-4515, for issues related to removal of
selected national coverage determinations.
Lindsey Baldwin, (410) 786-1694, for issues related to Medicare
coverage of opioid use disorder treatment services furnished by opioid
treatment programs.
Sabrina Ahmed, (410) 786-7499, or [email protected],
for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Aryanna Abouzari, (415) 744-3668, or
[email protected], for issues related to the Shared
Savings Program burden reduction proposal on OHCAs.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment and financial methodology.
Lucy Bertocci, (410) 786-4008, or [email protected],
for inquiries related to Shared Savings Program advance investment
payments, participation options and burden reduction policies.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to vaccine administration services.
Katie Parker, (410) 786-0537, for issues related to medical
necessity and documentation requirements for nonemergency, scheduled,
repetitive ambulance services.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider
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enrollment regulation updates (including for skilled nursing
facilities), State options for implementing Medicaid provider
enrollment affiliation provisions, and conditions of payment for DMEPOS
suppliers.
Mei Zhang, (410) 786-7837, and Kimberly Go, (410)786-4560, for
issues related to requirement for electronic prescribing for controlled
substances for a covered Part D drug under a prescription drug plan or
an MA-PD plan (section 2003 of the SUPPORT Act).
Amy Gruber, (410) 786-1542, or [email protected],
for issues related to the Medicare Ground Ambulance Data Collection
System and Ambulance Fee Schedule (AFS).
Sundus Ashar, [email protected], for issues related to
HCPCS Level II Coding for skin substitutes.
Renee O'Neill, (410) 786-8821, or Kati Moore, (410) 786-5471, for
inquiries related to Merit-based Incentive Payment System (MIPS).
Richard Jensen, (410) 786-6126, for inquiries related to
Alternative Payment Models (APMs).
Lindsey Baldwin, (410) 786-1694 for inquiries related to Opioid
Treatment Programs: CY 2022 Methadone Payment Exception.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
This major final rule revises payment polices under the Medicare
PFS and makes other policy changes, including to the implementation of
certain provisions of the Consolidated Appropriations Act, 2022 (CAA,
2022) (Pub. L. 117-103, March 15, 2022), Protecting Medicare and
American Farmers from Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71,
December 10, 2021), Infrastructure Investment and Jobs Act (Pub. L.
117-58, November 15, 2021), Consolidated Appropriations Act, 2021 (CAA,
2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of
2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act)
(Pub. L. 115-271, October 24, 2018), related to Medicare Part B
payment. In addition, this major final rule includes provisions
regarding other Medicare payment policies described in sections III.
and IV.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that each year we establish, by regulation, the
payment amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2023 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This final rule also includes discussions
and provisions regarding several other Medicare Part B payment
policies.
Specifically, this final rule addresses:
Determination of PE RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section
II.C.)
Payment for Medicare Telehealth Services Under Section
1834(m) of the Act (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Geographic Practice Cost Indices (GPCI) (section II.G.)
Determination of Malpractice Relative Value Units (RVUs)
(section II.H.)
Non-Face-to-Face/Remote Therapeutic Monitoring (RTM)
Services (section II.I.)
Payment for Skin Substitutes (section II.J.)
Provision to Allow Audiologists to Furnish Certain
Diagnostic Tests Without a Physician Order (section II.K.)
Provisions on Medicare Parts A and B Payment for Dental
Services (section II.L.)
Rebasing and Revising the Medicare Economic Index (MEI)
(section II.M.)
Requiring Manufacturers of Certain Single-dose Container
or Single-use Package Drugs to Provide Refunds with Respect to
Discarded Amounts (Sec. Sec. 414.902 and 414.940) (section III.A.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions, and Policies for Specimen
Collection Fees and Travel Allowance for Clinical Diagnostic Laboratory
Tests (section III.C.)
Expansion of Coverage for Colorectal Cancer Screening and
Reducing Barriers (section III.D.)
Removal of Selected National Coverage Determinations
(section III.E.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Medicare Part B Payment for Preventive Vaccine
Administration Services (section III.H.)
Medical Necessity and Documentation Requirements for
Nonemergency, Scheduled, Repetitive Ambulance Services (section III.I.)
Medicare Provider and Supplier Enrollment and Conditions
of DMEPOS Payment (section III.J.)
State Options for Implementing Medicaid Provider
Enrollment Affiliation Provision (section III.K.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.L.)
Medicare Ground Ambulance Data Collection System (GADCS)
(section III.M.)
Revisions to HCPCS Level II Coding Procedures for Skin
Substitutes Products (section III.N.)
Updates to the Quality Payment Program (section IV.)
Opioid Treatment Programs: CY 2022 Methadone Payment
Exception and Origin and Destination Requirements Under the Ambulance
Fee Schedule (section V.A.)
Finalizing provisions from the Medicare and Medicaid
Programs; Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency (CMS-1744-IFC) (Section V.B.)
Finalizing provisions from the Medicare and Medicaid
Programs, Basic Health Program, and Exchanges; Additional Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency and Delay of Certain Reporting Requirements for the Skilled
Nursing Facility Quality Reporting Program (CMS-5531-IFC) (Section
V.C.)
Collection of Information Requirements (section VI.)
Regulatory Impact Analysis (section VII.)
3. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic
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impacts, see section VII., Regulatory Impact Analysis, of this final
rule.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice (MP) expenses, as specified in section
1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of
the Act, we use a resource-based system for determining PE RVUs for
each physicians' service. We develop PE RVUs by considering the direct
and indirect practice resources involved in furnishing each service.
Direct expense categories include clinical labor, medical supplies, and
medical equipment. Indirect expenses include administrative labor,
office expense, and all other expenses. The sections that follow
provide more detailed information about the methodology for translating
the resources involved in furnishing each service into service specific
PE RVUs. We refer readers to the CY 2010 Physician Fee Schedule (PFS)
final rule with comment period (74 FR 61743 through 61748) for a more
detailed explanation of the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2023 PFS final rule PE/HR'' on the
CMS website under downloads for the CY 2023 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level based on the
direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the
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indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: a
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we
direct readers to the CY 2010 PFS final rule with comment period (74 FR
61745 through 61746). We also direct readers to the file titled
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our website under downloads for the CY 2023 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting
[[Page 69408]]
the services in the claims data, we use the expected specialty that we
identify on a list developed based on medical review and input from
expert interested parties. We display this list of expected specialty
assignments as part of the annual set of data files we make available
as part of notice and comment rulemaking and consider recommendations
from the RUC and other interested parties on changes to this list on an
annual basis. Services for which the specialty is automatically
assigned based on previously finalized policies under our established
methodology (for example, ``always therapy'' services) are unaffected
by the list of expected specialty assignments. We also finalized in the
CY 2018 PFS final rule (82 FR 52982 through 52983) a policy to apply
these service-level overrides for both PE and MP, rather than one or
the other category.
We did not make any proposals associated with the list of expected
specialty assignments for low volume services, however we received
public comments on this topic from interested parties. The following is
a summary of the comments we received and our responses.
Comment: Several commenters stated that they had performed an
analysis to identify all codes that meet the criteria to receive a
specialty override under this CMS policy and drafted updated
recommendations for CY 2023. Commenters stated that the purpose of
assigning a specialty to these codes was to avoid the major adverse
impact on MP RVUs that result from errors in specialty utilization data
magnified in representation (percentage) by small sample size. These
commenters submitted a list of several dozen low volume HCPCS codes
with recommended expected specialty assignments.
Response: After reviewing the information provided by the
commenters to determine that the submitted specialty assignments were
appropriate for the service in question, we are finalizing the
additions in Table 1 to the list of expected specialty assignments for
low volume services.
BILLING CODE 4150-28-P
[[Page 69409]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.000
[[Page 69410]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.001
BILLING CODE 4150-28-C
Comment: Commenters recommended an expected specialty assignment of
interventional cardiology for CPT codes 33370, 33894, 33895, 33897, and
33997.
Response: We do not have PE/HR data for the interventional
cardiology specialty as it was not part of the PPIS when it was
conducted in 2007. We use the cardiology specialty for this specialty's
PE/HR data, and therefore, we have crosswalked the CPT codes in
question to the cardiology specialty on the list of expected specialty
assignments for low volume services.
Comment: Commenters also recommended an expected specialty
assignment of hand surgery for CPT code 26705.
Response: During our review of claims data for this code, we found
that the most frequently reported specialty for CPT code 26705 was
orthopedic surgery, reported more than twice as often as the hand
surgery specialty. Therefore, we are finalizing orthopedic surgery and
not hand surgery as the expected specialty assignment for CPT code
26705.
We also note for commenters that each HCPCS code that appears on
the list of expected specialty assignments for low volume services
remains on the list from year to year, even if the volume for the code
in question rises to over 100 services for an individual calendar year.
The HCPCS codes and expected specialty assignment remain on the list,
and will be applied should the volume fall below 100 services in any
calendar year; there is no need to ``reactivate'' individual codes as
some commenters have suggested in past submissions.
After consideration of the public comments, we are finalizing the
updates to the list of expected specialty assignments for low volume
services as detailed above.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: the direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty specific indirect PE/HR data,
calculate specialty specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated
[[Page 69411]]
in Step 16 to the service level adjusted indirect allocators calculated
in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 2.
BILLING CODE 4150-28-P
[[Page 69412]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.002
BILLING CODE 4150-28-C
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time
[[Page 69413]]
accordingly. Table 3 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TR18NO22.003
We also adjust volume and time that correspond to other payment
rules, including special multiple procedure endoscopy rules and
multiple procedure payment reductions (MPPRs). We note that section
1848(c)(2)(B)(v) of the Act exempts certain reduced payments for
multiple imaging procedures and multiple therapy services from the BN
calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs
are not included in the development of the RVUs.
Beginning in CY 2022, section 1834(v)(1) of the Act required that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We applied the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 +
interest rate)[supcaret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally, 150,000 minutes.
usage = variable, see discussion below in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different
[[Page 69414]]
types of equipment, the vast majority of which fall in the range of 5
to 10 years, and none of which are lower than 2 years in duration. We
believe that the updated editions of this reference material remain the
most accurate source for estimating the useful life of depreciable
medical equipment.
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
Maintenance: We finalized the 5 percent factor for annual
maintenance in the CY 1998 PFS final rule with comment period (62 FR
33164). As we previously stated in the CY 2016 PFS final rule with
comment period (80 FR 70897), we do not believe the annual maintenance
factor for all equipment is precisely 5 percent, and we concur that the
current rate likely understates the true cost of maintaining some
equipment. We also noted that we believe it likely overstates the
maintenance costs for other equipment. When we solicited comments
regarding sources of data containing equipment maintenance rates,
commenters were unable to identify an auditable, robust data source
that could be used by CMS on a wide scale. We noted that we did not
believe voluntary submissions regarding the maintenance costs of
individual equipment items would be an appropriate methodology for
determining costs. As a result, in the absence of publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining a different maintenance
factor, we did not propose a variable maintenance factor for equipment
cost per minute pricing as we did not believe that we have sufficient
information at present. We noted that we would continue to investigate
potential avenues for determining equipment maintenance costs across a
broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 4.
[GRAPHIC] [TIFF OMITTED] TR18NO22.004
We did not propose and we are not finalizing any changes to the
equipment interest rates for CY 2023.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
For CY 2023, as explained in detail in section II.M. of this final
rule, we proposed to rebase and revise the Medicare Economic Index
(MEI) to reflect more current market conditions faced by physicians in
furnishing physicians' services. The MEI is an index that measures
changes in the market price of the inputs used to furnish physician
services. This index measure is authorized under section 1842(b)(3) of
the Act, and is developed by the CMS Office of the Actuary. We believe
that the MEI is the best measure available of the relative weights of
the three components in payments under the PFS--work, PE and
malpractice. Accordingly, we believe that to assure that the PFS
payments reflect the relative resources in each of these components as
required by section 1848(c)(3) of the Act, the RVUs used in developing
rates should reflect the same weights in each component as the MEI. In
the past, we have proposed (and subsequently, finalized) to accomplish
this by holding the work RVUs constant and adjusting the PE RVUs, the
MP RVUs and the CF to produce the appropriate balance in RVUs among the
PFS components and payment rates for individual services. The most
recent adjustments to the RVUs to reflect changes in the MEI weights
were made for the CY 2014 RVUs, when the MEI was last updated. In the
CY 2014 PFS proposed rule (78 FR 43287 through 43288) and final rule
(78 FR 74236 through 74237), we detailed the steps necessary to
accomplish this result (see steps 3, 10, and 18). The CY 2014 proposed
and final adjustments were consistent with our longstanding practice to
make adjustments to match the RVUs for the PFS components with the MEI
cost share weights for the components, including the adjustments
described in the CY 1999 PFS final rule (63 FR 58829), CY 2004 PFS
final rule (68 FR 63246 and 63247), and CY 2011 PFS final rule (75 FR
73275).
In the past when we have proposed a rebasing and/or revision of the
MEI, as we discuss in section II.M. of this final rule, we typically
have also proposed to modify steps 3 and 10 to adjust the aggregate
pools of PE costs (direct PE in step 3 and indirect PE in step 10) in
proportion to the change in the PE share in the rebased and revised MEI
cost share weights, as previously described in the CY 2014 PFS final
rule (78 FR 74236 and 74237), and to recalibrate the relativity
adjustment that we apply in step 18 as described in the CY 2014 PFS
final rule. Instead, we proposed to delay the adjustments to the PE
pools in steps 3 and 10 and the recalibration of the relativity
adjustment in step 18 until the public had an opportunity to comment on
the proposed rebased and revised MEI, which is being finalized for CY
2023, as discussed in section II.M. of this final rule. Because we
proposed significant methodological and data source changes to the MEI
for CY 2023 and significant time has elapsed since
[[Page 69415]]
the last rebasing and revision of the MEI, we explained that we believe
it is important to allow public comment and finalization of the
proposed MEI changes based on the review of public comment before we
incorporated the updated MEI into PFS ratesetting, and we believe this
is consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. We refer readers to the discussion of our comment solicitation
in section II.B. of this final rule, where we review our ongoing
efforts to update data inputs for PE to aid stability, transparency,
efficiency, and data adequacy. Similarly, we delayed the implementation
of the proposed rebased and revised MEI for use in the PE geographic
practice cost index (GPCI) and solicited comment on appropriate timing
for implementation for potential future rulemaking, discussed in detail
in section II.G. and section VI. of this final rule.
In light of the proposed delay in using the proposed update to the
MEI to make the adjustments to the PE pools in steps 3 and 10 and the
relativity adjustment in step 18, we solicited comment on when and how
to best incorporate the proposed rebased and revised MEI discussed in
section II.M. of the proposed rule into PFS ratesetting, and whether it
would be appropriate to consider a transition to full implementation
for potential future rulemaking. In section VI. of this final rule, we
present the impacts of implementing the proposed rebased and revised
MEI in PFS ratesetting through a 4-year transition and through full
immediate implementation, that is, with no transition period. Given the
significance of the impacts that result from a full implementation and
the interaction with other CY 2023 proposals, we did not consider
proposing to fully implement a rebased and revised MEI in PFS
ratesetting for CY 2023. We solicited comment on other implementation
strategies for potential future rulemaking that are not outlined in
section VI. of this final rule.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported our proposed delayed
implementation of the rebased and revised MEI in PFS ratesetting until
the public had an opportunity to comment on the proposed changes to the
MEI, as discussed in section II.M. of this final rule.
Response: We thank the commenters for their support.
Comment: Many commenters expressed concerns with the redistributive
impacts discussed in section VI. of the proposed rule, where we
discussed the alternative considered to implement the proposed rebased
and revised MEI in PFS ratesetting through a 4-year transition for CY
2023. Many of the commenters cited other proposals and their confluence
with the proposed rebased and revised MEI as a source of their concerns
regarding the implementation of the MEI in PFS ratesetting. Most
commenters noted that the AMA has said it intends to collect practice
cost data from physician practices in the near future and urged CMS to
pause consideration of other sources for the MEI until the AMA's
efforts have concluded. A few commenters urged CMS to implement the MEI
for PFS ratesetting when appropriate using a 4-year transition to
minimize shifts and maintain stability in PFS payments.
Response: We appreciate commenters' feedback, specifically as it
relates to updating PFS ratesetting, and will consider this information
in future rulemaking. We note that we discuss comments relating to the
proposed rebased and revised MEI in section II.M. of this final rule.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2023 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2023 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of clinical labor minutes for the preservice,
service, and post service periods for each code. In addition to
increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised codes that make use of this clinical labor activity when they
are reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the complex
case, and 5 minutes as the standard for the highly complex case. These
values were based upon a review of the existing minutes assigned for
this clinical labor activity; we determined that 2 minutes is the
duration for most services and a small number of codes
[[Page 69416]]
with more complex forms of digital imaging have higher values. We also
finalized standard times for a series of clinical labor tasks
associated with pathology services in the CY 2016 PFS final rule with
comment period (80 FR 70902). We do not believe these activities would
be dependent on number of blocks or batch size, and we believe that the
finalized standard values accurately reflect the typical time it takes
to perform these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (Review patient clinical extant information and
questionnaire) in the preservice period, and CA014 (Confirm order,
protocol exam) in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, we continue to believe that in these
cases, the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, one
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2023, we are continuing to display two versions of
the Labor Task Detail public use file: one version with the old listing
of clinical labor tasks, and one with the same tasks crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2023 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in
CY 2019 and continuing through CY 2022, we conducted a market-based
supply and equipment pricing update, using information developed by our
contractor, StrategyGen, which updated pricing recommendations for
approximately 1300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
to phase in our use of the new direct PE input pricing over a 4-year
period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25
percent (CY 2021), and 100/0 percent (CY 2022) split between new and
old pricing. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2023, we proposed to update the price of eight supplies and
two equipment items in response to the public submission of invoices
following the publication of the CY 2022 PFS final rule. The eight
supply and equipment items with proposed updated prices are listed in
the valuation of specific codes section of the preamble under Table 19,
CY 2023 Invoices Received for Existing Direct PE Inputs.
We received the following comments on our proposal to update the
price of eight supplies and two equipment items in response to the
public submission of invoices following the publication of the CY 2022
PFS final rule:
[[Page 69417]]
Comment: Several commenters submitted comments to clarify that the
invoice they included in their submission that was identified as the
Lysing Reagent (SL089) supply was intended for a different supply item,
the Lysing Solution (SL039). The commenters stated that our proposed
reduction of the price for the SL089 supply appeared to be based on the
invoice they had as misidentified as being for the SL089 supply, when
it was intended for the SL039 supply. The commenters asked CMS to
disregard the earlier mistaken submission and submitted additional
invoices with updated pricing for the SL089 supply for consideration to
correct the oversight in their original submission.
Response: We appreciate the clarification from the commenters and
the updated invoices with pricing information for the SL089 supply. We
are finalizing an increase in the price of the Lysing Reagent (SL089)
supply to $5.53 based on the average of the ten submitted invoices from
the commenter. (Note: the separate discussion of the SL039 supply below
is based on a different invoice submitted by a different interested
party unconnected to the SL089 supply. We believe it is appropriate to
consider and revise the price for the SL089 supply based on the
clarification and new invoices submitted by commenters for that supply.
However, given that the invoice for SL039 submitted by these commenters
was not intended to be submitted for the SL039 supply, we did not
consider the invoice for SL039 that was mistakenly submitted by these
commenters.)
Comment: Several commenters stated their support for the proposed
pricing changes to the EP014 and EP088 equipment items and the SA117,
SK082, SL024, SL030, SL061, and SL469 supply items. The commenters
urged CMS to finalize them as proposed in the final rule.
Response: We appreciate the support for our proposed pricing from
the commenters.
In the proposed rule, we did not propose to update the price of
another eight supplies and two equipment items which were the subject
of public submission of invoices. Our rationale for not updating these
prices is detailed below:
Acetic acid 5% (SH001): We received an invoice submission
that would suggest an increase in price from 3 cents per ml to 9.5
cents per ml for the SH001 supply. However, the invoice stated that
this price was for an ``Alcian Blue 1% in 3% Acetic Acid pH 2.5''
supply and it is not clear that this represents the same supply as the
``Acetic acid 5%'' described by the SH001 supply item. We also do not
believe that the typical price for this supply has increased 200
percent in the 3 years since StrategyGen researched its pricing,
especially given that we increased the price for the SH001 supply from
1.2 cents in CY 2019 to its current price of 3 cents for CY 2022.
Cytology, lysing soln (CytoLyt) (SL039): We received an
invoice submission that would suggest an increase in price from 6 cents
per ml to 80 cents per ml for the SL039 supply. We do not believe that
the typical price for this supply has increased 1200% in the 3 years
since StrategyGen researched its pricing, especially given that we
increased the price for the SL039 supply from 3.4 cents in CY 2019 to
its current price of 6 cents for CY 2022.
Fixative (for tissue specimen) (SL068): We received an
invoice submission that would suggest an increase in price from 1.3
cents per ml to $4.87 for the SL068 supply. We believe that this was
the result of confusion on the part of the interested party regarding
the unit quantity for the SL068 supply. This item is paid on a per ml
basis and not a per unit basis; there was not enough information on the
submitted invoice to determine the price for the SL068 supply on a per
ml basis.
Ethanol, 100% (SL189): We received an invoice submission
that would suggest an increase in price from 0.33 cents per ml to 1.2
cents per ml for the SL189 supply. However, we noted that the invoice
was based on the price for a single gallon of 100% ethanol which is
typically sold in much larger quantities than a single gallon. We found
that 100% ethanol was readily available for sale online in larger unit
sizes and the current price of 0.33 cents per ml (based on the past
StrategyGen market research) appears to be accurate based on online
bulk pricing. We also found that the submitted invoices for the
ethanol, 70% (SL190), ethanol, 95% (SL248), and stain, PAP OG-6 (SL491)
supplies were also based on pricing for a single gallon. Each of these
supply items was also available for purchase in larger unit quantities
which indicated that the current pricing remained typical for these
supplies. Therefore, we did not propose to update the prices for the
SL189, SL190, SL248 or SL491 supply, as we do not believe that the
higher prices paid for smaller quantities of these supplies would be
typical.
Biohazard specimen transport bag (SM008): We received an
invoice submission that would suggest an increase in price from 8 cents
to 45 cents for the SM008 supply. However, it is not clear that the
item described on the invoice is the same item as the SM008 supply. The
invoice states only that the price is for ``Supplied Case Red Bags''
which was not enough information to determine if this would be typical
for the SM008 supply. We also do not believe that the typical price for
this supply has increased 460 percent in the 3 years since StrategyGen
researched its pricing, especially given that we increased the price
for the SM008 supply from 3.5 cents in CY 2019 to its current price of
8 cents for CY 2022.
International Normalized Ratio (INR) analysis and
reporting system w-software (EQ312): We did not receive an invoice for
this equipment item, only a letter stating that the cost of the EQ312
equipment should be increased from the current price of $19,325 to
$1,600,000. We previously finalized a policy in the CY 2011 PFS final
rule (75 FR 73205) to update supply and equipment prices through an
invoice submission process. We require pricing data indicative of the
typical market price of the supply or equipment item in question to
update the price. It is not sufficient to state a different price
without providing information to support a change in pricing. Since we
did not receive an invoice to support the higher costs asserted in the
letter, we did not propose a new price for the EQ312 equipment item.
Interested parties are encouraged to submit invoices with their public
comments or, if outside the notice and comment rulemaking process, via
email at [email protected]. We also noted that in order
to be considered a direct PE input, an equipment item must be
individually allocable to a particular patient for a particular
service. Costs associated with the implementation, maintenance, and
upgrade of equipment that is not individually allocable to a particular
patient for a particular service, or other costs associated with
running a practice, would typically be classified as forms of indirect
PE under our methodology.
Prior to the publication of the proposed rule, the same interested
parties that addressed the pricing of the EQ312 equipment item
questioned the assignment of the General Practice specialty crosswalk
for indirect PE for home Prothrombin Time (PT)/INR monitoring services.
These individuals stated that the predominant code used for PT/INR
monitoring (HCPCS code G0249) will be significantly and negatively
impacted by the continuing implementation over a 4-year period of
changes in the clinical labor rates
[[Page 69418]]
finalized in the CY 2022 PFS final rule (86 FR 65024). The individuals
requested that CMS change the crosswalk for home PT/INR monitoring
services to All Physicians or Pathology which would partially offset
the reduction that HCPCS code G0249 is facing due to changes in the
clinical labor rates.
We noted for these interested parties in the CY 2021 PFS final rule
(85 FR 84477 and 84478)that we finalized a crosswalk to the General
Practice specialty for home PT/INR monitoring services (HCPCS codes
G0248, G0249, and G0250). The data submitted by the commenters at the
time indicated that the direct-to-indirect cost percentages to furnish
home PT/INR monitoring are in the range of 31:69, similar to the ratio
associated with the General Practice specialty. We disagreed, as we did
in response to comments in the CY 2021 PFS final rule, that these home
PT/INR monitoring services should be reassigned to a different
specialty that is less reflective of the cost structure for these
services to offset reductions in payment for the services that result
from an unrelated policy proposal (the clinical labor pricing update).
We also noted that we had not received any new information about PT/INR
monitoring services since CY 2021 to indicate that Pathology would be
more accurate choices for use in indirect PE allocation but are open to
receiving new relevant information that CMS could consider in future
rulemaking. As such, we did not propose to change the assigned
specialty for PT/INR services; we direct interested parties to the
previous discussion of this topic in the CY 2021 PFS final rule (85 FR
84477 and 84478) and again in the CY 2022 PFS final rule (86 FR 65000).
Interested parties are encouraged to submit new information to support
the most accurate specialty choice to use in indirect PE allocation for
PT/INR monitoring services distinct from what has previously been
reviewed during the last two rule cycles.
Comment: A commenter submitted additional direct and indirect cost
data associated with pricing the INR analysis and reporting system w-
software (EQ312) equipment. The commenter stated that they arrived at
this amount based upon detailed review of all of the software system
and related expenses involved with furnishing home INR monitoring
services, including up front equipment and software purchases that
comprise direct equipment practice expenses, up front maintenance and
support services that comprise indirect practice expenses, and
recurring support and telecommunications services that also comprise
indirect practice expenses. The commenter submitted invoices detailing
a one-time direct cost of $69,621, a one-time indirect cost of
$84,126.31, and recurring annual costs of $963,638.52 associated with
the EQ312 equipment.
Response: We agree with the commenter that the invoices support an
increase in the purchase price of the equipment from the current
$19,325 to the price of $69,621 listed on the invoices. However, we
disagree that the one-time indirect cost of $84,126.31 or recurring
annual costs of $963,638.52 listed on the invoices would constitute
forms of direct PE which would be included in the equipment's price.
The indirect costs on the submitted invoices are for project management
and service order costs while the recurring annual costs comprise
monthly maintenance and telecommunications expenses. We agree that
these are real costs associated with the software, however they are
classified as forms of indirect PE under our current methodology. The
equipment cost formula that we use already incorporates maintenance and
interest rates costs into the per-minute pricing calculation; if we
were to include these expenses in the equipment cost as a form of
direct PE, we would be making duplicative payment for the same
expenses. We are therefore finalizing an increase in the price of the
EQ312 equipment to $69,621 but not including the indirect and recurring
annual costs in the equipment price as they are classified as forms of
indirect PE.
Comment: The same commenter reiterated their previous request made
in PFS rulemaking for CY 2021 for CMS to change the crosswalk for home
PT/INR monitoring services from the previously finalized General
Practice specialty to the All Physicians or Pathology specialty. The
commenter stated that the code used to report ongoing home PT/INR
monitoring (HCPCS code G0249) will again be significantly and
negatively impacted in CY 2023 as a result of changes in the clinical
labor rates with the corresponding budget neutrality adjustment and the
drop in the conversion factor. The commenter stated that the Pathology
specialty provides a better reflection of the indirect to direct costs
associated with home PT/INR monitoring and also reflects a more
appropriate indirect practice cost index (IPCI) for a service with very
high indirect costs, such as home PT/IN monitoring. The commenter
stated their belief that the indirect cost data captured in their
submitted invoices supports a crosswalk to the Pathology specialty
given the higher indirect costs of furnishing these services, including
the on-going software costs that are not captured in the direct PE
input; and that this specialty crosswalk change would help offset the
cuts in the proposed rate for HCPCS code G0249.
Response: We continue to believe that assignment of the Pathology
specialty for home PT/INR monitoring services as requested by the
commenters would not be appropriate. As we stated in the proposed rule,
we continue to disagree that these home PT/INR monitoring services
should be reassigned to a different specialty that is less reflective
of the cost structure for these services to offset reductions in
payment that result from an unrelated policy proposal (the clinical
labor pricing update). The commenter stated that home PT/INR monitoring
services have high indirect expenses and suggested that this supported
assignment of a specialty with a higher direct-to-indirect expense
ratio than General Practice (which has a 31 to 69 percent ratio), such
as Pathology (which has a 26 to 74 percent ratio). However, this is a
misunderstanding of the direct-to-indirect ratio for each specialty,
which is a ratio based on data from the Physician Practice Expense
Information Survey (PPIS) conducted back in 2007. The direct-to-
indirect ratio is merely a ratio, and not indicative of a specialty
having higher or lower indirect expenses in absolute terms. Higher
indirect expenses for a specialty are not correlated with a higher
percentage of indirects as compared with directs in that ratio; in
fact, the Independent Diagnostic Testing Facility specialty has both
the highest indirect expenses of any specialty, as well as a low direct
to indirect ratio (50 to 50%) precisely because IDTFs also have very
high direct expenses as well. Similarly, the Pathology specialty had
lower indirect expenses on the PPIS than the General Practice
specialty; this contradicts the commenter's contention that the high
indirect costs for home PT/INR monitoring services would justify a
change to the Pathology specialty. We continue to believe that the data
submitted by the commenters in the CY 2021 PFS final rule (85 FR 84477
and 84478) indicated that the direct-to-indirect cost percentages to
furnish home PT/INR monitoring are not reflective of the Pathology
specialty.
We note that the PE methodology, which relies on the allocation of
indirect costs based on the magnitude of direct costs, should
appropriately reflect the typical costs for the specialty the
commenters suggest. However, we are cognizant that approach may not
work
[[Page 69419]]
in all cases, particularly for newer services with costs that are not
well accounted for in our PE methodology, or services with cost
structures that do not necessarily reflect the specialties furnishing
them. Although we have previously assigned the General Practice
specialty to these codes, interested parties have provided additional
information about these services suggesting assignment to a different
specialty for purposes of allocating indirect cost. We believe that, as
we work to identify ways to update the PE methodology and our data
sources to better reflect costs for all services and changes in medical
practice, it is best to apply a consistent approach in setting rates
that does not over-allocate cost, which could result in significant
increases in payments for these services. Considering our concerns, we
will switch the specialty assignment for these services to the All
Physician specialty, consistent with how we have treated other new
services that do not quite fit our PE methodology in recent rulemaking
(see for example the discussion of HCPCS codes G2082 and G2083 in the
CY 2022 PFS final rule (86 FR 65014 and 65015) and again in this rule).
We believe this will allow for improved stability in payments, and
preserve access to this care for beneficiaries, while we work to
identify longer term solutions.
Remote musculoskeletal therapy system (EQ402): We received
an invoice submission for a price of $1,000 for the EQ402 equipment
item. Since this equipment already has a price of $1,000 we did not
propose to make any changes in the pricing; we thank the interested
party for their invoice submission confirming the current price.
The following are additional comments that we received associated
with supply and equipment pricing:
Comment: Several commenters requested the creation of a new supply
code to describe an alternate form of a basic injection pack.
Commenters stated that for many services the use of Chloraprep
(chlorhexidine) for intact skin preparation has become more typical
than Betadine (povidone-iodine solution) and that the current basic
injection pack described by supply code SA041 no longer accurately
reflects typical resource use. Commenters requested that CMS create an
alternative pack which instead includes Chloraprep (chlorhexidine) so
that specialties can select the injection pack with the most
appropriate antiseptic. Commenters requested that the new pack should
mirror the SA041 basic injection pack with the addition of the patient
prep swab, 1.5 ml chloraprep (SJ081) supply and removal of the Betadine
povidone soln (SJ041) and sponge tipped applicator (SG009) supplies.
Response: We appreciate the feedback from the commenters on the
changing nature of what supplies are typically included in basic
injection packs, and as a result, we are creating an alternate
injection pack with the new supply code SA135 which will be priced at
$14.12 as detailed in Table 5.
[GRAPHIC] [TIFF OMITTED] TR18NO22.005
After consideration of the public comments, we are finalizing the
creation of the SA135 alternate injection pack. We note that this
supply is not currently included in any CPT or HCPCS codes but has been
added to our direct PE database for future use in services.
Comment: A commenter expressed concern that the prices for the
injectable fluorescein (SH033) and lidocaine (SH049) supplies were too
low. The commenter submitted invoices for both supply items and
requested that they be used to update their respective prices.
Response: After reviewing the invoices, we are updating the price
of the fluorescein injectable (5ml uou) (SH033) supply from $38.02 to
$49.13 based on an average of prices from five submitted invoices. We
did not include the sixth invoice for the SH033 supply (with a listed
price of $64.80) in this average as it described a different type of
injectable fluorescein from the other five invoices (it described 2 mL
of a 25% solution as opposed to 5 mL of a 10% solution on the other
five invoices).
We are not updating the price of the lidocaine 2% w-epidural
injectable (Xylocaine w-epi) (SH049) supply as the two submitted
invoices were not usable for pricing. One of the invoices detailed a
3.5% type of lidocaine while the SH049 supply code specifies that it is
for 2% lidocaine. The other submitted invoice specifically noted that
it was a ``preservative free'' version of lidocaine which was more
expensive than the typical item; we do not agree that this invoice
would be accurate for establishing a new national price for the SH049
supply. We remain interested in additional information regarding
updated pricing information for the SH049 and other supply/equipment
codes; as noted below, interested parties are encouraged to submit
invoices with their public comments or, if outside the notice and
comment rulemaking
[[Page 69420]]
process, via email at [email protected].
We did not make any proposals associated with HCPCS codes G0460
(Autologous platelet rich plasma for chronic wounds/ulcers, including
phlebotomy, centrifugation, and all other preparatory procedures,
administration and dressings, per treatment) or G0465 (Autologous
platelet rich plasma (prp) for diabetic chronic wounds/ulcers, using an
FDA-cleared device (includes administration, dressings, phlebotomy,
centrifugation, and all other preparatory procedures, per treatment))
in the CY 2023 PFS proposed rule. In the CY 2021 PFS final rule, we
established contractor pricing for HCPCS code G0460 for CY 2021 (85
FR84497-84498). In the CY 2022 PFS final rule, we finalized a policy to
maintain contractor pricing for HCPCS code G0460 as we did not have
sufficient information to establish national pricing, and we did not
receive public comments on either the proposal or comment solicitation
to support establishing a national payment rate (86 FR 65019-65020). It
remains unclear to us what the typical supply inputs would be for HCPCS
code G0460 and whether they would include the use of the new 3C patch
system.
Comment: Following the publication of the CY 2023 PFS proposed
rule, we received two comments on the pricing of HCPCS codes G0460 and
G0465, and the 3C patch system supply which is topically applied for
the management of exuding cutaneous wounds, such as leg ulcers,
pressure ulcers, and diabetic ulcers and mechanically or surgically-
debrided wounds. One commenter submitted invoices associated with the
pricing of the 3C patch system (SD343) supply for which we established
a price of $625.00 in the CY 2021 PFS final rule (85 FR 84498). The
commenter requested that CMS update its supply database based on
invoices submitted for SD343 to reflect an updated price of $750.00 per
unit. The commenter also requested national pricing for HCPCS codes
G0460 and G0465, expressing concern that insufficient payment
disproportionately impacts vulnerable populations. The commenter
requested a payment rate of $1,408.90 for HCPCS G0465 in the office
setting, stating that this rate would appropriately account for the
purchase of the 3C patch, as well as the other related costs and supply
inputs required for point of care creation and administration.
Another commenter requested the establishment of new codes to allow
for quantity-specific payment when multiple patches are needed to treat
wounds of various surface sizes. Both commenters stated that many
months have passed since CMS updated NCD 270.3 in April 2021 (for
Blood-Derived Products for Chronic, Non-Healing Wounds), however, the
3C patch remains nearly inaccessible in the office and facility
settings because of insufficient payment by MACs. Both commenters
suggested that, to date, just one MAC has assigned a payment rate for
HCPCS code G0465, which the commenters believe is too low to cover the
cost to purchase and administer the patch. One commenter expressed
support for the professional fee to administer the patch in the
facility setting determined by this MAC, First Coast ($135.97), with
the appropriate geographic adjustments, and urged CMS either to apply
this rate nationally or to require MACs to set a carrier price in a
timely and transparent manner. Both commenters stated that health care
providers in the remaining MAC jurisdictions have faced denials even
when they follow the coverage guidelines specified by our NCD 270.3.
One commenter contended that, as of 2019, 27.5 percent of the
traditional Medicare beneficiaries had a diabetes diagnosis. Both
commenters highlighted that, within this population, the prevalence of
diabetes is significantly higher among Medicare FFS beneficiaries who
identify as Native American or Black/African American relative to their
white counterparts, and furthermore, these historically underserved
populations are also more likely to develop foot ulcers and infections
that require amputation. The commenters stated that the 3C Patch has
the potential to help cure these concerning health disparities and
requested that we make the 3C Patch accessible by establishing national
pricing for HCPCS codes G0460 and G0465.
Response: We do not have enough information to establish national
pricing at this time. We will consider the commenters' feedback for
future rulemaking while maintaining contractor pricing for CY 2023,
which will allow for more flexibility for contractors to establish
appropriate pricing using available information. We appreciate the
invoice submission with additional pricing information for the SD343
supply and will update our supply database for supply code SD343 at a
price of $678.57 based on an average of the submitted invoices.
(1) Invoice Submission
We remind readers that we routinely accept public submission of
invoices as part of our process for developing payment rates for new,
revised, and potentially misvalued codes. Often these invoices are
submitted in conjunction with the RUC-recommended values for the codes.
To be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th deadline we noted for
consideration of RUC recommendations. However, we will consider
invoices submitted as public comments during the comment period
following the publication of the PFS proposed rule, and would consider
any invoices received after February 10th or outside of the public
comment process as part of our established annual process for requests
to update supply and equipment prices. Interested parties are
encouraged to submit invoices with their public comments or, if outside
the notice and comment rulemaking process, via email at
[email protected].
c. Clinical Labor Pricing Update
Section 220(a) of the PAMA provides that the Secretary may collect
or obtain information from any eligible professional or any other
source on the resources directly or indirectly related to furnishing
services for which payment is made under the PFS, and that such
information may be used in the determination of relative values for
services under the PFS. Such information may include the time involved
in furnishing services; the amounts, types and prices of PE inputs;
overhead and accounting information for practices of physicians and
other suppliers, and any other elements that would improve the
valuation of services under the PFS.
Beginning in CY 2019, we updated the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 was
the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Interested parties raised concerns that the long delay since
clinical labor
[[Page 69421]]
pricing was last updated created a significant disparity between CMS'
clinical wage data and the market average for clinical labor. In recent
years, a number of interested parties suggested that certain wage rates
were inadequate because they did not reflect current labor rate
information. Some interested parties also stated that updating the
supply and equipment pricing without updating the clinical labor
pricing could create distortions in the allocation of direct PE. They
argued that since the pool of aggregated direct PE inputs is budget
neutral, if these rates are not routinely updated, clinical labor may
become undervalued over time relative to equipment and supplies,
especially since the supply and equipment prices are in the process of
being updated. There was considerable interest among interested parties
in updating the clinical labor rates, and when we solicited comment on
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR
59480), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We believed it was
important to update the clinical labor pricing to maintain relativity
with the recent supply and equipment pricing updates. We proposed to
use the methodology outlined in the CY 2002 PFS final rule (66 FR
55257), which draws primarily from BLS wage data, to calculate updated
clinical labor pricing. As we stated in the CY 2002 PFS final rule, the
BLS' reputation for publishing valid estimates that are nationally
representative led to the choice to use the BLS data as the main
source. We believe that the BLS wage data continues to be the most
accurate source to use as a basis for clinical labor pricing and this
data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for our
CY 2022 clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we used the national salary data from the
Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at www.salaryexpert.com). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. We ultimately finalized the use of
median BLS wage data, as opposed to mean BLS wage data, in response to
comments in the CY 2022 PFS final rule. To account for the employers'
cost of providing fringe benefits, such as sick leave, we finalized the
use of a benefits multiplier of 1.296 based on a BLS release from June
17, 2021 (USDL-21-1094). As an example of this process, for the
Physical Therapy Aide (L023A) clinical labor type, the BLS data
reflected a median hourly wage rate of $12.98, which we multiplied by
the 1.296 benefits modifier and then divided by 60 minutes to arrive at
the finalized per-minute rate of $0.28.
After considering the comments on our CY 2022 proposals, we agreed
with commenters that the use of a multi-year transition would help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year
transition, as we have for several other broad-based updates or
methodological changes. While we recognized that using a 4-year
transition to implement the update means that we will continue to rely
in part on outdated data for clinical labor pricing until the change is
fully completed in CY 2025, we agreed with the commenters that these
significant updates to PE valuation should be implemented in the same
way, and for the same reasons, as for other major updates to pricing
such as the recent supply and equipment update. Therefore, we finalized
the implementation of the clinical labor pricing update over 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. An example of the
transition from the current to the fully-implemented new pricing that
we finalized in the CY 2022 PFS final rule is provided in Table 6.
[[Page 69422]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.006
(1) CY 2023 Clinical Labor Pricing Update Proposals
For CY 2023, we received information from one interested party
regarding the pricing of the Histotechnologist (L037B) clinical labor
type. The interested party provided data from the 2019 Wage Survey of
Medical Laboratories which supported an increase in the per-minute rate
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This
rate of $0.64 for the L037B clinical labor type is a close match to the
online salary data that we had for the Histotechnologist and matches
the $0.64 rate that we initially proposed for L037B in the CY 2022 PFS
proposed rule. Based on the wage data provided by the commenter, we
proposed this $0.64 rate for the L037B clinical labor type for CY 2023;
we also proposed a slight increase in the pricing for the Lab Tech/
Histotechnologist (L035A) clinical labor type from $0.55 to $0.60 as it
is a blend of the wage rate for the Lab Technician (L033A) and
Histotechnologist clinical labor types. We also proposed the same
increase to $0.60 for the Angio Technician (L041A) clinical labor type,
as we previously established a policy in the CY 2022 PFS final rule
that the pricing for the L041A clinical labor type would match the rate
for the L035A clinical labor type (86 FR 65032). The proposed pricing
increase for these three clinical labor types is included in Table 7;
the CY 2023 pricing for all other clinical labor types would remain
unchanged from the pricing finalized in the CY 2022 PFS final rule.
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Comment: Several commenters noted that there was an error in the
proposed clinical labor pricing table in the CY 2023 PFS proposed rule
(87 FR 45874) where the final rate per minute for the L041A Angio
Technician clinical labor type was incorrectly listed at 0.58 rather
than the correct 0.60 as specified in the preamble text.
Response: We agree that the incorrect rate per minute for the L041A
clinical labor type was reflected in Table 5 of the proposed rule, and
have corrected this error in Table 7 of this final rule. We apologize
for any confusion that may have been caused by this mistake.
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the course of the 4-year transition period. We updated the pricing
of a number of clinical labor types in the CY 2022 PFS final rule in
response to information provided by commenters. For the full discussion
of the clinical labor pricing update, we direct readers to the CY 2022
PFS final rule (86 FR 65020 through 65037).
The following is a summary of the comments we received and our
responses.
Comment: Several commenters stated their support for the proposed
pricing updates to the Histotechnologist (L037B) and the Lab Tech/
Histotechnologist (L035A) clinical labor types and urged CMS to
finalize the updated pricing.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Several commenters requested that CMS update the clinical
labor description of the Angio Technician (L041A) clinical labor type
to ``Vascular Interventional Technologist.'' The commenters stated that
this updated title for the L041A clinical labor type would better align
with industry recognition of the advanced certification required to
assist physicians with minimally invasive, image-guided vascular
procedures.
Response: We appreciate the feedback and are finalizing a change in
the descriptive text of the L041A clinical labor type from ``Angio
Technician'' to ``Vascular Interventional Technologist'' as requested
by the commenter.
Comment: Several commenters disagreed with the proposed pricing for
several different technologist clinical labor types. The commenters
stated that basic certification is required for a radiologic
technologist and that there are additional advanced modality
certifications, such as for Computed Tomography (CT), Magnetic
Resonance (MR), and Vascular Intervention (VI), which require
additional educational programs and training for these advanced
modalities/disciplines. The commenters stated that the proposed pricing
for the Vascular Interventional Technologist (L041A), the Mammography
Technologist (L043A), the CT Technologist (L046A), and the MRI
Technologist (L047A) clinical labor types did not reflect the training
and certification required for these occupations. The commenters
submitted wage data from the 2022 Radiologic Technologist Wage and
Salary Survey and requested that the pricing for these four clinical
labor types be updated to reflect the wage data from the submitted
survey.
Response: When we initiated the clinical labor pricing update last
year, we lacked specific wage data for the Vascular Interventional
Technologist (L041A), the Mammography Technologist (L043A), and the CT
Technologist (L046A) clinical labor types; and relied on crosswalks for
their pricing. Based on the information contained in the 2022
Radiologic Technologist Wage and Salary Survey, we now have specific
wage data which will allow us to no longer rely on crosswalks for
pricing for these clinical labor types. Therefore, we are finalizing an
update in the pricing of these three clinical labor types: from 0.60 to
0.84 for the Vascular Interventional Technologist (L041A), from 0.63 to
0.79 for the Mammography Technologist (L043A), and from 0.76 to 0.78
for the CT Technologist (L046A). For the MRI Technologist (L047A), we
were able to make use of direct BLS wage data for the occupation. In
addition, since we continue to believe that the BLS is the most
accurate source of information for wage data, we are not finalizing an
increase in the pricing of the L047A clinical labor type. As a
reminder, CY 2023 is the second year of the four-year transition to the
updated clinical labor pricing, and we will continue to transition the
prices established for these three clinical labor types over the next
two years of the update.
Comment: A commenter thanked CMS for the agency's recent work in
updating clinical labor pricing and stated that nurses and other
nonphysician providers have been drastically undervalued for many years
which could help to alleviate staffing shortages. The commenter stated
that the table of clinical labor types in the proposed rule listed
registered nurses (RNs) as their own category for labor pricing under
the L051A clinical labor code, but then also included RNs in eight
other categories of clinical labor with other practitioners. The
commenter requested having RNs identified uniquely and removing the RN
option from the other clinical labor categories, as the commenter
stated that leaving RNs in other categories would only make the
clinical labor update more confusing and could end up disadvantaging
RNs in the long term which could exacerbate the current staffing
shortage and worsen patient care.
Response: We do not agree that RNs should be removed from the other
eight clinical labor types currently listed in our direct PE database.
There is a long history of using these ``blended'' clinical labor
categories under the PFS, and together these eight clinical labor types
make up the overwhelming majority of all clinical labor (especially the
RN/LPN/MTA blend described by the L037D clinical labor code). In the
absence of alternative pricing information to value these blended
clinical labor types, we continue to believe that the proposed prices
are the most accurate valuations. We also note for the commenter that
the pricing for the RN (L051A) clinical labor type is drawn directly
from BLS wage data and the inclusion of RNs in other ``blended''
clinical labor types has no effect on the pricing of the L051A category
itself.
Comment: A commenter stated that the current RN/LPN (L042A)
clinical labor type assigned to CPT code 36516 did not accurately
reflect the costs associated with this procedure. The
[[Page 69425]]
commenter stated that CPT code 36516 is a complex extracorporeal blood
therapy procedure, conducted over a 5-1/2 to 6-hour period, that
requires extensively trained and experienced nurse operators known as
apheresis nurses. The commenter stated that the current assignment of
the RN/LPN (L042A) clinical labor type for CPT code 36516 seriously
undervalues the critical nurse labor cost component of this nearly six-
hour procedure and requested that CMS establish a new ``Apheresis
Nurse'' clinical labor type with a valuation of approximately $1.14 per
minute. The commenter also stated that there are additional supply
items not currently captured in the direct PE inputs for CPT code 36516
including a 4-liter accessory waste bag, several types of fluids, and
biohazard waste costs.
Response: We remind the commenter that we did not propose the
creation of any new clinical labor types nor did we propose any changes
in the direct PE inputs for CPT code 36516. If the commenter has reason
to believe that the RN/LPN (L042A) clinical labor type is not capturing
the typical labor costs associated with CPT code 36516 or that there
are additional supply costs not being captured in its direct PE inputs,
we encourage them to nominate CPT code 35616 as potentially misvalued
for additional review.
Comment: Several commenters stated that, to promote predictability
and stability in physician payments and mitigate the financial impacts
of significant fluctuations in physician payments that might accompany
the clinical labor pricing update, CMS should consider using a
threshold to limit the level of reductions in payments for specific
services that would occur in a single year. Several commenters noted
that in the CY 2023 Inpatient Prospective Payment System final rule,
CMS implemented a permanent 5 percent cap on the reduction in an MS-
DRG's relative weight in a given fiscal year; the commenters suggested
applying a similar cap of 5 percent, 10 percent, or 15 percent for the
Physician Fee Schedule.
Response: We agree with the commenters on the importance of
avoiding potentially disruptive changes in payment for affected
interested parties and the need to promote payment stability from year-
to-year. This is why we finalized the use of a multi-year transition
for the clinical labor update in last year's CY 2022 PFS final rule to
help smooth out the changes in payment resulting from the updated data
(86 FR 65024). We also note for the commenters that section 1848(c)(7)
of the Act, as added by section 220(e) of the PAMA, specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased-in
over a 2-year period. For additional information regarding the phase-in
of significant RVU reductions, we direct readers to the CY 2016 PFS
final rule with comment period (80 FR 70927 through 70929). Given the
mechanisms already in place to smooth payment changes and promote
stability, and considering the need to establish appropriate resource-
based valuations, we do not believe the limitation suggested by
commenters is warranted.
Comment: Several commenters stated that CMS should prioritize
stability and predictability over ongoing updates and temporarily
freeze the implementation of further policy updates. These commenters
requested that CMS pause the ongoing clinical labor pricing update to
avoid significant payment redistributions associated with the pricing
update.
Response: We finalized the implementation of the clinical labor
pricing update through the use of a 4-year transition in the CY 2022
PFS final rule (86 FR 65024). As we stated at the time, although we
recognize that payment for some services will be reduced as a result of
the pricing update due to the budget neutrality requirements of the
PFS, we do not believe that this is a reason to refrain from updating
clinical labor pricing to reflect changes in resource costs over time.
The PFS is a resource-based relative value payment system that
necessarily relies on accuracy in the pricing of resource inputs;
continuing to use clinical labor cost data that are nearly two decades
old would maintain distortions in relativity that undervalue many
services which involve a higher proportion of clinical labor. As noted
above, we also finalized the implementation of the pricing update
through a 4-year transition to help address the concerns of the
commenters about stabilizing RVUs and reducing large fluctuations in
year-to-year payments.
After consideration of the comments, we are finalizing the clinical
labor prices as shown in Table 8.
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As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the remaining course of the 4-year transition period. We welcome
additional feedback on clinical labor pricing from commenters in next
year's rulemaking cycle, especially any data that will continue to
improve the accuracy of our finalized pricing.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
We did not propose any technical corrections to the direct PE input
database or supporting files in the proposed rule. However, commenters
identified the following issues after we issued the CY 2023 PFS
proposed rule:
Comment: Several commenters requested that the SD332 bubble
contrast supply, an ultrasound-specific contrast agent, should be
removed from the direct PE inputs for CPT codes 76978 (Ultrasound,
targeted dynamic microbubble sonographic contrast characterization
(non-cardiac); initial lesion) and 76979 (Ultrasound, targeted dynamic
microbubble sonographic contrast characterization (non-cardiac); each
additional lesion with separate injection). Commenters stated that this
supply item does not need to be included in the direct PE inputs for
these two CPT codes because contrast agents are reported separately
using existing HCPCS Level II supply codes, such as Q9950 (Injection,
sulfur hexafluoride lipid microspheres, per ml).
Response: We appreciate the additional information from the
commenters indicating that the SD332 supply is duplicative for CPT
codes 76978 and 76979 since the supply is separately reported using
HCPCS Level II supply codes. Therefore, we are finalizing the removal
of the SD332 supply from these two CPT codes.
In the CY 2020 PFS final rule (84 FR 63102 through 63104), we
created two new HCPCS G codes, G2082 and G2083, effective January 1,
2020, on an interim final basis for the provision of self-administered
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that summed the values associated with several codes
(85 FR 84641 through 84642). Following the publication of the CY 2021
PFS final rule, interested parties expressed concerns that the
finalized PE RVU had decreased for HCPCS codes G2082 and G2083 as
compared to the proposed valuation and as compared to the previous CY
2020 interim final valuation. Interested parties questioned whether
there had been an error in the PE allocation since CMS had finalized
increases in the direct PE inputs for the services.
We reviewed the indirect PE allocation for HCPCS codes G2082 and
G2083 in response to the interested party inquiry and discovered a
technical change that was applied in error. Specifically, we
inadvertently assigned a different physician specialty than we intended
(``All Physicians'') to HCPCS codes G2082 and G2083 for indirect PE
allocation in our ratesetting process during valuation of these codes
in the CY 2020 PFS final rule, and continued that assignment into the
CY 2021 PFS proposed rule. This specialty assignment caused the PE
value for these services to be higher than anticipated for CY 2020. We
intended to revise the assigned physician specialty for these codes to
``General Practice'' in the CY 2021 PFS final rule; however, we
neglected to discuss this change in the course of PFS rulemaking for CY
2021. Since we initially applied this technical change in the CY 2021
PFS final rule without providing an explanation, we issued a correction
notice (86 FR 14690) to remove this change from the CY 2021 PFS final
rule, and to instead maintain the All Physicians specialty assignment
through CY 2021. We apologize for any confusion this may have caused.
For CY 2022, we finalized our proposal to maintain the currently
assigned physician specialty for indirect PE allocation for HCPCS codes
G2082 and G2083 to maintain payment consistency with the rates
published in the CY 2020 PFS final rule and the CY 2021 PFS proposed
rule. Although we had previously intended to assign the General
Practice specialty to these codes, interested parties have provided
additional information about these services suggesting that maintaining
the All Physicians specialty assignment for these codes will help
maintain payment stability and preserve access to this care for
beneficiaries. We solicited public comments to help us discern which
specialty would be the most appropriate to use for indirect PE
allocation for HCPCS codes G2082 and G2083. We note that the PE
methodology, which relies on the allocation of indirect costs based on
the magnitude of direct costs, should appropriately reflect the typical
costs for the specialty the commenters suggest. For example, we do not
believe
[[Page 69428]]
it would be appropriate to assign the Psychiatry specialty for these
services given that HCPCS codes G2082 and G2083 include the high direct
costs associated with esketamine supplies. The Psychiatry specialty is
an outlier compared to most other specialties, allocating indirect
costs at a 15:1 ratio based on direct costs because psychiatry services
typically have very low direct costs. Assignment of most other
specialties would result in allocation of direct costs at roughly a 3:1
ratio. We requested that commenters explain in their comments how the
indirect PE allocation would affect the payment for these services.
Specifically, to ensure appropriate payment for HCPCS codes G2082 and
G2083, we wanted to get a better understanding of the indirect costs
associated with these services, relative to other services furnished by
the suggested specialty.
As we noted in the CY 2021 PFS final rule (85 FR 84498 through
84499) and CY 2022 PFS final rule (86 FR 65042), the RAND Corporation
was studying potential improvements to our PE allocation methodology
and the data that underlie it. We were interested in exploring ways
that the PE methodology can be updated, which could include
improvements to the indirect PE methodology to address newer services
similar to those described by G2082 and G2083 which have a direct to
indirect ratio that does not match their most commonly billed
specialties. In CY 2022, we agreed with the commenters who supported
the proposal to maintain the currently assigned physician specialty
(All Physicians) for indirect PE allocation for these codes. After
consideration of the public comments, we finalized our proposal to
maintain the All Physicians specialty for indirect PE allocation for
HCPCS codes G2082 and G2083 for CY 2022.
For CY 2023, we did not make any proposals regarding the assigned
physician specialty for indirect PE allocation for HCPCS codes G2082
and G2083; however, we received public comments on this topic from
interested parties. The following is a summary of the comments we
received and our responses.
Comment: One commenter urged CMS to adopt a clear and recurring
process to update, on an annual basis, supply costs for codes G2082 and
G2083 with the most recently available wholesale acquisition cost (WAC)
data and to include the ``Psychiatry'' specialty type in the allocation
of the indirect PE for G2082 and G083. The commenter believed these
recommended actions directly support the following two priority CMS
initiatives: the CMS Behavioral Health Strategy and an approach to
improve the PE methodology within the PFS. The commenter stated that
the technical correction for CY 2021 to assign these HCPCS codes to the
``All Physician'' specialty preserved Medicare beneficiary access and
was an improvement over the original CMS intent to assign them to the
``General Practice'' specialty but ``demonstrated the sensitive and
intricate dependency of Medicare beneficiary access on reimbursement.''
The commenter urged CMS to provide additional insight behind its
specialty designation of ``All Physicians'' for HCPCS codes G2082 and
G2083, and argued that CMS deviated from its normal practice of using
the specialty mix contained in the claims data for these codes. The
commenter stated that, while CMS has cited concerns in applying the
actual specialty mix, CMS has not provided sufficient information or
data to suggest that the rates produced when the ``Psychiatry''
specialty is included produces an inaccurate payment. The commenter
also requested that CMS consider the implementation of policies that
allow for the construction of specialty blends in unique cases, such as
HCPCS codes G2082 and G2083, in which the agency has concerns about
applying a service's actual specialty mix. The commenter stated that,
based on utilization data published with the CY 2023 PFS proposed rule,
over 70 percent of practitioners administering esketamine are
psychiatrists. Considering that it is primarily psychiatrists
administering esketamine and CMS recognizes the imperative to improve
the indirect PE and PFS rate setting methodology for behavioral health
services, the commenter recommended a transition of specialty
designation for HCPCS codes G2082 and G2083 to its actual specialty mix
through a three-year phased-in approach. The commenter recognized CMS'
concerns about assigning the Psychiatry specialty for HCPCS codes G2082
and G2083 given the higher supply costs for these services, but
recommended that CMS adopt a specialty blend of three-fourths
``Psychiatry'' specialty type and one-fourth ``All Physician''
specialty type. The commenter believed that this specialty blend would
result in appropriate reimbursement and acknowledge the role of
psychiatrists while also addressing our concerns.
The commenter also stated that in CY 2021, CMS updated the price
for the esketamine supply item for these codes using wholesale
acquisition cost (WAC) data from the most recent available quarter, but
did not again update the price using the latest WAC data in the CY 2022
PFS final rule, or propose to update the price in the CY 2023 PFS
proposed rule. The commenter stated that, based on WAC data on
submitted invoices for the most recently available quarter, the supply
input that describes 56 mg (supply code SH109) for HCPCS code G2082
should be priced at $683.67, and the supply input describing 84 mg of
esketamine (supply code SH110) for HCPCS code G2083 should be priced at
$1025.50. The commenter urged CMS to align with its prior action and
stated intention to address input price updates in future rulemaking by
updating the supply pricing for SH109 and SH110 using WAC data
annually, and to make clear the additional data or processes interested
parties should follow to support annual updates for the esketamine
supply items for these codes.
Response: We continue to believe that the All Physicians specialty
most accurately captures the indirect PE allocation associated with
HCPCS codes G2082 and G2083. We do not assign a blended combination of
specialties for any other services and the commenters did not provide
new data to support a change in specialty assignment aside from noting
that many practitioners who report HCPCS codes G2082 and G2083 are in
the Psychiatry specialty. We continue to believe that it would not be
accurate to assign the Psychiatry specialty for HCPCS codes G2082 and
G2083 due to its outlier status among specialties, whereby Psychiatry
allocates indirect costs at a 15:1 ratio based on direct costs as
compared to most other specialties having approximately a 3:1 ratio. We
do not believe that Psychiatry would be an accurate specialty
designation for HCPCS codes G2082 and G2083 given the high direct costs
associated with esketamine (which would translate into
disproportionately high indirect PE allocation at the 15:1 ratio). We
also disagree that these services should be reassigned to a different
specialty to offset reductions in payment that result from an unrelated
policy proposal (the clinical labor pricing update).
However, to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we agree with the
commenters that we should update supply costs to reflect the wholesale
acquisition cost (WAC) data from the most recent available quarter. For
HCPCS code G2082, we are finalizing an updated price of $683.67 for the
supply input that describes 56 mg (supply code SH109) and for HCPCS
code G2083, we are finalizing an
[[Page 69429]]
updated price of $1025.50 for the supply input describing 84 mg of
esketamine (supply code SH110) based on the submitted invoices.
After consideration of the public comments, we continue to believe
that the All Physician specialty is the most accurate specialty
assignment for HCPCS codes G2082 and G2083, and we are not finalizing
any changes to the specialty assignment. However, as noted above we are
finalizing an increase in the price of the SH109 supply to $683.67 and
an increase in the price of the SH110 supply to $1025.50 to reflect the
updated market-based prices associated with esketamine. We also
received comments on other policies relating to these services that
were not addressed in the CY 2023 PFS proposed rule, and which we are
not addressing in this final rule. We appreciate the feedback from the
commenters and will take it into consideration for possible future
rulemaking.
5. Soliciting Public Comment on Strategies for Updates To Practice
Expense Data Collection and Methodology
The PE inputs used in setting PFS rates, including both the
development of PE RVUs and, historically, the relative shares among
work, PE, and malpractice RVUs across the PFS, are central in
developing accurate rates and maintaining appropriate relativity among
PFS services and overall payment among the professionals and suppliers
paid under the PFS. Consequently, the underlying PE data inputs are a
consistent point of interest among interested parties. However, unlike
other payment systems with cost reporting systems, PFS data inputs are
primarily based on exogenous proprietary data that become available as
the data are collected. Specifically, we rely on historical survey data
(almost all of which is over a decade old), some publicly available
data collected for other purposes (for example, Bureau of Labor
Statistics (BLS) wage data), recommendations from the American Medical
Association and other provider groups, and annual Medicare claims data.
a. History of Updates to PE Inputs
Each year we continue to improve accuracy, predictability, and
sustainability of updates to the PE valuation methodology to reduce the
risks of possible misvaluation and other unintended outcomes. We have
continued to develop policies geared toward providing more consistent
updates to the direct PE inputs used in PFS ratesetting, including
supply/equipment pricing and clinical labor rates. These efforts to
develop these policies should contribute to improved standardization
and transparency for all PE inputs used to update the PFS. As we
continue our work to improve the information we use in our PE
methodology, we issued a general comment solicitation to better
understand how we might improve the collection of PE data inputs and
refine the PE methodology.
In recent years, we have refined specific PE data inputs using a
combination of market research and publicly available data (for
example, market research on medical supply and equipment items and BLS
data to update clinical labor wages) to update the direct PE data
inputs used in the PFS ratesetting process. Last year, we implemented a
final transition year for supply and equipment pricing updates and
started the first year of a 4-year phase-in update to the clinical
labor rates. However, the indirect PE data inputs remain tied to legacy
information that is well over a decade old. To build on much needed
progress, we now believe indirect PE would also benefit from a refresh
that implements similar standard and routine updates. We believe that a
data refresh, and use of data sources that receive routine refreshes,
would reduce the likelihood of unpredictable shifts in payment,
especially when such shifts could be driven by the age of data
available rather than comprehensive information about changes in actual
costs.
b. Data Collection, Analysis and Findings
In light of feedback from interested parties, CMS has prioritized
stability and predictability over ongoing updates, and has taken a
measured approach to updating PE data inputs. We have worked with
interested parties and CMS contractors over a period of years to study
the landscape and identify possible strategies to reshape the PE
portion of physician payments. The fundamental issues are clear, but
thought leaders and subject matter experts have advocated for more than
one tenable approach to updating our PE methodology. Thus, we must
balance the various interests of the public, and any path forward
should allow for ongoing and routine cycles of PE updates.
Of the various PE data inputs, we believe that indirect PE data
inputs, which reflected costs such as office rent, IT costs, and other
non-clinical expenses, present the opportunity to build consistency,
transparency, and predictability into our methodology to update PE data
inputs. The primary source for indirect PE information is the Physician
Practice Information Survey (PPIS), fielded by the AMA. The survey was
most recently conducted in 2007 and 2008 (reflecting 2006 data). The
survey respondents were self-employed physicians and selected
nonphysician practitioners.
In general, interested parties have expressed the following
concerns regarding CMS's approach to indirect PE allocation:
CMS seems to rely on increasingly out-of-date data
sources, and there is a dearth of mechanisms to update empirical
inputs.
The approach exacerbates payment differentials that
possibly create inappropriate variation of reimbursement across
ambulatory places of service (for example, significantly higher
payments for the same service provided in a hospital outpatient
department versus a physician office).
CMS's method of indirect PE allocation may not accurately
reflected variation in PE across different types of services, different
practice characteristics, or evolving business models. Beyond these
issues, we have also explored other concerns with our indirect PE
allocation method in depth in previous rulemaking. For example, refer
to our previous comment solicitation and discussion of resource costs
for services involving the use of innovative technologies in our CY
2022 PFS proposed rule (86 FR 39125). PE data inputs, and the
methodological and evidence-based principles that shape use of such
information in the context of reimbursement, are discussed in depth in
a RAND Corporation (``RAND'') report prepared for CMS, entitled
Practice Expense Methodology and Data Collection Research and Analysis,
available at https://www.rand.org/pubs/research_reports/RR2166.html.\1\
---------------------------------------------------------------------------
\1\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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Various interested parties have taken issue with the use of certain
costs in our current PE allocation methodology that they do not believe
are associated with increased indirect PE. Some interested parties
argue that the costs of disposable supplies, especially expensive
supplies, and equipment are not relevant to allocating indirect PE; or
that similarly, work in the facility setting (for example, work RVUs
for surgical procedures) is not relevant to allocating indirect PE,
[[Page 69430]]
though they agree that work in the office setting may be relevant to
allocating indirect PE.\2\ However, we do not believe that there is
sufficient, if any, data or peer-reviewed evidence available to
definitively show that shifting indirect PE allocations based on the
setting of care, or based on specialty, would result in improved
allocations of PE that reflect true costs. Further, varying indirect PE
allocations based on setting of care or based on specialty might create
unintended consequences such as reduced access to care for
beneficiaries, or reduced competition and autonomy of small group
practices or individual clinicians whose revenue is based in part on
services furnished under contract in the facility setting.
---------------------------------------------------------------------------
\2\ Kazungu, Jacob S., Edwine W. Barasa, Melvin Obadha, and Jane
Chuma. ``What Characteristics of Provider Payment Mechanisms
Influence Health Care Providers' Behaviour? A Literature Review.''
The International Journal of Health Planning and Management 33, no.
4 (October 2018): e892-905. https://doi.org/10.1002/hpm.2565.
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We believe it is necessary to establish a roadmap toward more
routine PE updates, especially because potentially improper or outdated
allocation of PE across services may affect access to certain services,
which could exacerbate disparities in care and outcomes. Establishing
payments that better reflect current practice costs would mitigate
possible unintended consequences, such as labor market distortions due
to indirect cost allocations that do not reflect the current evolution
of health care practice.\3\ Interested parties have reiterated their
desire for CMS to move away from the current PE allocation approach and
continued to raise concerns with CMS's methodology and the underlying
PE data inputs. In response to these and other concerns, we continue to
review the methodology we use to establish the PE RVUs and to identify
refinements. As part of this effort, we have contracted with RAND to
develop and assess potential improvements in the current methodology
used to allocate indirect practice costs in determining PE RVUs for a
service, model alternative methodologies for determining PE RVUs, and
identify and assess alternative data sources that CMS could use to
regularly update indirect practice cost estimates.\4\
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\3\ Laugesen, Miriam J. ``Regarding `Committee Representation
and Medicare Reimbursements: An Examination of the Resource-Based
Relative Value Scale.' '' Health Services Research 53, no. 6
(December 2018): 4123-31. https://doi.org/10.1111/1475-6773.13084.
\4\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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In this final rule, we are signaling our intent to move to a
standardized and routine approach to valuation of indirect PE and we
solicited feedback from interested parties on what this may entail,
given our discussion above. We would propose the new approach to
valuation of indirect PE in future rulemaking.
We solicited comment on the following topics related to
identification of the appropriate instrument, methods, and timing for
updating specialty-specific PE data:
Potential approaches to design, revision, and fielding of
a PE survey that foster transparency (for example, transparency in
terms of the methods of survey design, the content of the survey
instrument, and access to raw results for informing PFS ratesetting);
and
Mechanisms to ensure that data collection and response
sampling adequately represent physicians and non-physician
practitioners across various practice ownership types, specialties,
geographies, and affiliations.
We also solicited comment on any alternatives to the above that
would result in more predictable results, increased efficiencies, or
reduced burdens. For example:
Use of statistical clustering or other methods that would
facilitate a shift away from specialty-specific inputs to inputs that
relate to homogenous groups of specialties without a large change in
valuation relative to the current PE allocations.
Avenues by which indirect PE can be moved for facility to
non-facility payments, based on data reflecting site of service cost
differences.
Methods to adjust PE to avoid the unintended effects of
undervaluing cognitive services due to low indirect PE.
A standardized mechanism and publicly available means to
track and submit structured data and supporting documentation that
informs pricing of supplies or equipment.
Sound methodological approaches to offset circularity
distortions, where variable costs are higher than necessary costs for
practices with higher revenue.
We also solicited comment on the cadence, frequency, and phase-in
of adjustments for each major area of prices associated with direct PE
inputs (Clinical Labor, Supplies/Equipment). We requested that
commenters address the following:
Whether CMS should stagger updates year-to-year for each
update, or establish ``milestone'' years at regular intervals during
which all direct PE inputs would be updated in the same year.
The optimal method of phasing in the aggregate effect of
adjustments, such that the impacts of updates gradually ramp up to a
full 100 percent over the course of a few years (for example, 25
percent of the aggregate adjustment in Year 1, then 50 percent of the
aggregate adjustment in Year 2, etc.).
How often CMS should repeat the cycle to ensure that
direct PE inputs are based on the most up-to-date information,
considering the burden of data collection on both respondents and
researchers fielding instruments or maintaining datasets that generate
data.
We received public comments on data collection, analysis and
findings. The following is a summary of the comments we received and
our responses.
Comment: Most commenters that responded to this RFI recommended
that CMS delay any change to update the indirect PE survey inputs. Many
commenters urged CMS to wait for AMA data collection efforts prior to
implementing changes. In responding to our RFI, the AMA RUC underscored
that CMS wrote in this year's proposed rule that the AMA PPIS continues
to be the best available source of data necessary for the purpose of
calculating indirect PE. AMA also points to the fact that CMS has
relied on AMA physician cost data for 50 years in updating the MEI and
30 years updating the RBRVS. Additionally, the RUC urged that CMS
continue to work with the AMA and various specialty societies involved
in the previous data collection effort, and wait for an updated set of
data to become available for use. The AMA indicated that it has
continued work on updates and would likely be ready by early CY 2024
with refreshed data. One commenter submitted a jointly-signed letter
that did not support the AMA RUC approaches, and described a different
means of data collection and analysis for updating the PE methodology.
In addition to emphasizing some of the same themes noted in findings
from RAND's review of the PE landscape, the letter recommended that CMS
form an expert advisory group, multidisciplinary in composition, and
backed with a dedicated research and development team of CMS staff, to
support CMS' strategic plans to update PFS ratesetting. In this letter,
the commenter also posited that indirect allocations would eventually
be unnecessary, as the methodology could be evolved toward an entirely
different means to capture actual costs of services. Overall, we
received few direct responses to many
[[Page 69431]]
of the specific prompts included in our request for information.
Response: We reiterate that we continue to believe that the current
AMA PPIS data does represent the best available source of information
at this time. However, as we continue to engage with a broad range of
perspectives from interested parties who frequently ask for CMS policy
to better reflect rapidly changing health care costs, we acknowledge,
in consideration of these perspectives and our work to analyze these
issues, that these concerns may be addressed by consistent and
transparent data refreshes.
We remain interested in possible alternatives to use of a sole
source of data. We believe that transparency and repeatability should
be key principles for examining future work to update indirect PE
inputs. We have clear agreement among interested parties that the
economic and medical landscapes have changed, and rapidly. Our intent
remains to seek data that capture such changes on a more frequent
basis, and allow for others to explore and study how best to assess and
account for changes with more rapid feedback loops. Conversely, we
understand that the competitive marketplace may create a dynamic
whereby some market participants receive revenue for the licensing and
sharing of proprietary information itself. We believe it remains
important to avoid interference with this type of business arrangement
between vendors and their customers, yet, we also believe that there is
a strong public interest to support open, transparent, and low-cost
means to conduct research on these topics. For example, we are not
aware of any independent, third-party, peer-reviewed research focused
on the characteristics of the health care labor market in light of
advancements in automation (for example, empirical analysis of how
software implementation may have a causal link to changes in the health
care labor market). Simply put, there are no available studies that
adequately answer the question, with sufficient predictive power and
adequate empirical data, of how much clinical labor is saved, or
replaced, by use of automation, in the context of furnishing
practitioner services. Further, many, if not all examinations of
automation and its effects on labor take a far broader focus than
health care workforce only, and mainly use anecdotal information, with
conclusions or hypotheses that focus on job gains/losses. We note that
many commenters highlighted themes this year focusing on labor
shortages, rather than labor surplusage. The comments that noted
refreshed survey data alone would address the need for more precise,
and up-to-date, allocations of indirect expenses seem discordant with
other comments we received about updating our PE methodology to account
for current advancements in automation, and associated software costs.
Therefore, there are a number of competing concerns that CMS must take
into account when considering updated data sources, which also should
support and enable ongoing refinements to our PE methodology.
For these reasons, it is possible that CMS would look to using
verifiable, more objective data sets in the future to supplement or
augment survey data alone. Such action would be similar to how certain
specialty data are used in current indirect PE calculations, and
sourced from specialty societies themselves, as required by statute, in
some cases as PPIS data were not available. Alternatively, we may
explore the use of data already in the public domain. We believe that
fast-moving changes to the distribution of costs and use of evolving
technology, and more generally the innovations in how vendors support
practices, reshape indirect expenses in ways that would require
flexible but standardized methods to account for these on a more
frequent basis in our ratesetting methodology.
We reiterate our needs described in our initial discussion for this
RFI. We note that this interest to develop a roadmap for updates to our
PE methodology is underpinned by a need to have better understanding of
repeatability and reproducibility of results, as we move toward more
consistent and frequent data collection. Some commenters expressed
concerns over bias and validity. We believe some of those concerns may
be alleviated by having means to refresh data and make transparent with
more accuracy and precision how the information affects valuations for
services payable under the PFS.
Further, we note that it is possible that with the current timing
for AMA's planned updates, we would be unable to refresh data for
several years. This would result in CMS using data nearly 20 years old
to form indirect PE inputs used to set rates for services on the PFS.
As these survey data are static inputs, and leverage only the responses
gathered at the time of collection, which are applied using a
methodology without any dynamic variables, this is quite distinct from
each of the MEI and various other inputs in PE methodology.
We believe both the somewhat stale and static aspects of the PPIS,
along with expected timing for updates is significantly at tension with
the feedback we receive on a regular basis. Consistently, a broad range
of perspectives across various interested parties frequently ask for
CMS to better reflect costs in what has been a rapidly changing health
care payment landscape. The medical community and others continue to
point to shortcomings in our ratesetting methodology, which may be
improved by consistent and transparent data refreshes.
Additionally, we acknowledge that some hold disparate points of
view about the above process of updating our PE methodology. We note
that part of the public comment process aims to encourage thinking and
build consensus, or identifies a lack of consensus. We appreciate the
dialogue, multiple perspectives, and encourage that the broader
national community of health policy thought leaders, health economists,
and health systems researchers, all continue to have such conversations
with one another and with CMS. A diversity of perspectives is important
to foster a more robust set of options for the best available path
forward.
We again thank commenters for submitting feedback on our RFI. We
reiterate that our RFI does not contain any specific proposals for CY
2023. We will consider possible proposals in future rulemaking.
c. Changes to Health Care Delivery and Practice Ownership Structures,
and Business Relationships Among Clinicians and Health Care
Organizations
Market consolidation, and shifts in workforce alignment, as well as
an evolution in the type of business entities predominant in health
care markets, all suggest significant transformation in the composition
and proportions of practice expenses required to furnish care. These
evolving conditions collectively highlight the need for a comprehensive
update to PE data inputs, and possibly the PE methodology as a
whole.\5\ Ideally, more comprehensive PE data inputs and a different PE
calculation methodology would better account for indirect/overhead
costs, current trends in the delivery of health care, the use of
machine learning technology, and EHRs, and the cost differentials in
[[Page 69432]]
independent versus facility-based practices.
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\5\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
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We solicited comment on current and evolving trends in health care
business arrangements, use of technology, or similar topics that might
affect or factor into indirect PE calculations. We are interested in
learning whether any PE data inputs may be obsolete, unnecessary, or
misrepresentative of the actual costs involved in operating a medical
practice.
We received public comments on current and evolving trends in
health care business arrangements, use of technology, or similar topics
that might affect or factor into indirect PE calculations. The
following is a summary of the comments we received and our responses.
Comment: A few commenters responding to our prompt to explore
avenues by which indirect PE can be moved for facility to non-facility
payments, based on data reflecting site of service cost differences,
suggested that indirect PE inputs should not be part of payment for the
facility rate of payment.
Commenters explained that because the facility bears the indirect
costs for provision of services at the facility, and the physician or
practitioner would receive indirect PE allocations for any in-office
services, the indirect PE portion of the facility fee for a physician
service is unwarranted.
Response: We note that the face value of a change that would reduce
the indirect PE portions of our current facility fees for physicians'
services to zero may have merit. We have open questions about this
feedback, which we will explore further in our ongoing research. We
believe, and related feedback from interested parties suggests, there
are two considerable shifts in today's healthcare business models.
First, many physicians and NPP's have become employed staff, versus
independent practitioners. Second, the landscape includes far more
variation in the ways that organizations interact and contract for
clinical staff and auxiliary personnel, and structure their
compensation. We would aim to better understand whether potentially
reducing to zero any indirect PE portion that is part of the facility
fee for physician services may or may not reduce competition, or have
the unintended effect of favoring certain forms of arrangements over
others.
Further, before proposing any policy, we would need to understand
whether the policy could address related open questions. Our work with
RAND to explore the relationship between different types of indirect
costs and direct cost inputs remains one of few empirical efforts to
examine the issue in-depth. In this year, and in previous years, when
we have requested similar information from the public, we continue to
receive anecdotal, if any evidence, when feedback from commenters aims
to take issue with findings in the RAND studies.
d. Unintended Consequences and Missing Information
We solicited comment on additional information that we may have not
considered or discussed above about updating and maintaining PE data
inputs, as well as any unintended impacts (or positive outcomes) that
could result from changes to the overall strategy. We are especially
interested in public comment on any concerns about beneficiaries'
access to care, possible consolidation of group practices, or burden on
small group or solo practitioners. We are also interested in public
comments on any collateral program integrity or quality issues that
could arise from potential updates. We requested that any respondents
who provide feedback ensure that the response includes discussion of
any possible health equity impacts.
We received public comments on unintended consequences and missing
information. The following is a summary of the comments we received and
our responses.
Comment: A few commenters expressed concern that topics of AI, a
related evolution of software and technology used to support provision
of services, and ties to health equity are not well-suited for the
process of updates to our annual rulemaking cycle. Commenters expressed
concerns that the public comment process alone is not sufficient to
provide information, and requested a separate RFI. We received a
similar response from many interested parties that question how CMS has
in the past, and will in the future, address definition of topics and
terms that shape our PE inputs.
Response: We encourage interested parties to continue to provide
feedback and suggestions to CMS that in general, give an evidentiary
basis to shape optimal PE data collection and methodological
adjustments over time. Submissions should discuss the feasibility and
burden associated with implementation of any suggested adjustments, and
should highlight opportunities to optimize the cadence, frequency, and
phase-in of resulting adjustments. In the interim, we will continue to
consider ways that we may engage in dialogue with interested parties to
better understand how to address possible long-term policies and
methods for PFS ratesetting.
6. Soliciting Public Comment on Strategies for Improving Global
Surgical Package Valuation
In preparation for future rulemaking, we solicited public comment
on strategies to improve the accuracy of payment for the global
surgical packages (herein referred to as ``global packages') under the
PFS. Currently, there are over 4,000 physicians' services paid as
global packages under the PFS. Global packages generally include the
surgical procedure and any services typically provided during the pre-
and postoperative periods (including evaluation and management (E/M)
services and hospital discharge services). There are three types of
global packages:
The 0-day global package, which includes the procedure and
the preoperative and postoperative physicians' services on the day of
the procedure.
The 10-day global package, which includes services on the
day of, and 10 days after, the procedure.
The 90-day global package, which includes services
furnished one day prior to the procedure, and on the day of, and 90
days immediately following the day of the procedure.
More detail about how global packages are billed and what
activities are included may be found in Chapter 12, Section 40, of the
Medicare Claims Processing Manual (Pub. 100-04).
We have applied the concept of global payment for some procedures
since the inception of the PFS on January 1, 1992 (54 FR 59502).
However, in the past decade we have engaged with interested parties
regarding numerous concerns about the accuracy and validity of the
valuation of global packages, with particular attention paid to the E/M
visits included in the services. We have made previous requests for
public feedback on global packages, including solicitations for
information or data that could be used to help support more accurate
valuations. We now wish to expand on our conversations with the public,
considering the current status of a multi-year data collection and
analysis project, as well as ongoing changes we have made to payments
for other types of patient care that may impact the global packages.
a. History of Global Valuation Discussion
In the CY 2013 PFS proposed rule (77 FR 44737 through 44738), we
discussed two reports released by the HHS Office of the Inspector
General in 2005 and
[[Page 69433]]
2012 with findings that practitioners were performing fewer E/M
postoperative visits than had been included in the valuation for these
global packages, suggesting that Medicare was paying for care that was
not being delivered. In response to the concerns raised by the OIG
reports, we solicited public feedback on methods of obtaining accurate
and current data on E/M services furnished as part of a global package.
We summarized public comment in the CY 2013 PFS final rule (77 FR 68911
through 68913).
In the CY 2015 PFS proposed rule (79 FR 40341), we delved into
barriers to accurate valuation of global packages, especially as
compared to other forms of bundled payments made under the inpatient or
outpatient prospective payment systems. In addition to the ongoing
concerns about whether E/M visits presumed to be furnished in
connection with global packages were actually being performed by the
physician receiving the global package payment, we noted issues such
as:
E/M services in the global period that occur post-
discharge are valued with PE values associated with follow-up visits in
the physician's office. Many of these follow-up visits may occur in a
hospital outpatient department where the physician may not incur many
PE costs.
The direct PE inputs often differ slightly between an E/M
service furnished in a global period and a stand-alone E/M service. For
example, follow-up visits for certain surgeries may include specialized
clinical labor such as an RN rather than a general nurse blend.
The types of physicians furnishing a specific service
dictate the direct and indirect percentages, as well as the indirect
practice cost index, in the PE methodology. Most surgical specialties
have a lower direct percentage mix, resulting in higher indirect costs
that extend to the E/M visits in the global periods.
Because the E/M visits embedded in the global package are
not reported separately and do not appear in claims data, it is
difficult to quantify the number and level of E/M services furnished in
connection with global packages under the fee-for-service system.
In some cases we have limited billing of the 10- and 90-
day global packages in conjunction with some of the payment policies
intended to encourage coordination of care through payments for non-
face-to-face services, such as transitional care management and chronic
care management, because of presumed overlap between these services.
To address these concerns, we solicited comment and finalized a
policy in the CY 2015 PFS final rule (79 FR 67586) intended to, over a
period of several years, transition all services with 10-day and 90-day
global periods to 0-day global periods. As stated in the CY 2015 PFS
final rule, we believed it would be more accurate to value the surgical
procedure-day services separately from postop E/M visits, and would
avoid potentially duplicative or unwarranted payments. For our full
discussion and rationale, refer to 79 FR 67586 through 67591.
Implementation of this policy, however, was halted by the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 110-14).
Section 523(a) of the MACRA amended section 1848(c)(8) of the Act to
prohibit the Secretary from implementing the transition policy
finalized in the CY 2015 PFS final rule. The amendments to section
1848(c)(8) of the Act also require CMS to collect additional data on
how best to value global packages and to reassess every 4 years the
continued need for this data collection. Section 1848(c)(8) of the Act
directs CMS to use the information collected to improve the accuracy of
valuation of these services under the PFS starting in CY 2019. (Refer
to the CY 2016 PFS final rule at 80 FR 70915 for additional discussion
of these requirements.)
In response to the statutory requirements as added by section
523(a) of the MACRA, we engaged in multiple discussions with interested
parties about methods of data collection and analysis, including
through public comment solicitation in the CY 2016 PFS proposed rule
(80 FR 41707) and CY 2017 PFS proposed rule (81 FR 46191), a national
listening session, and a town hall meeting. (Materials for the January
20, 2016 listening session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-01-20-MCRA-Presentation.pdf. The transcript of the town hall meeting held August
25, 2016 is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf.) In the CY 2017 PFS final rule (81 FR 80209 through
80213), we finalized a claims-based process to collect data from
practitioners on both the number and level of postoperative visits
furnished as part of the 10- and 90-day global packages. We also
contracted with RAND to support this data collection and analysis.
b. Data Collection, Analysis, and Findings
In 2019, RAND issued two reports based on its analysis of the data
collected through the data collection process we established. The
reports examined, using claims-based and survey-based data, the number
of postoperative visits furnished during the 10- and 90-day global
periods for certain high-volume procedures and the level of visits
furnished for certain procedures. (Complete details about the data
collected are discussed in the CY 2017 PFS final rule starting at 81 FR
80212, the CY 2020 PFS final rule at 84 FR 62857, and in the reports
themselves, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.)
Notably, RAND's analysis found that, according to claims-based data,
the reported number of E/M visits matched the expected number (included
for purposes of PFS valuation) for only 4 percent of reviewed 10-day
global packages and 38 percent of reviewed 90-day global packages.
Based on these analyses, RAND released a third report that analyzed the
current valuation of global packages based on the difference between
the number of postoperative E/M visits observed via the claims-based
data collection process and the expected number of such E/M visits. The
report modeled how valuation for global packages would change by
adjusting the work RVUs, physician time, and direct PE inputs to
reflect the observed number of E/M visits. The report provided
hypothetical valuations for the global packages based on these
adjustments. These three RAND reports were made available to the public
and are available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection.
The RAND reports were shared with the public, and we received
public comment about these reports in the CY 2020 PFS final rule (84 FR
62866). Public commenters raised concerns about the findings in the
reports, including questions as to whether the E/M visit data were
collected from a true representative sample of practitioners, and
various other challenges to the validity of the RAND methodology. Other
members of the public, however, were supportive of our overall efforts
to collect and analyze the data, and supplied additional data similarly
suggesting that the 10- and 90-day global packages are overvalued. In
2021, RAND responded to the CY 2020 public comments that were critical
of
[[Page 69434]]
the methodologies used in the three earlier reports in a separate
report entitled, ``Responses to Comments on RAND Global Services
Reports,'' which is available at https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/.
While some interested parties have challenged the methodology or
conclusions of the RAND reports, we have not yet received data
suggesting that postoperative E/M visits are being performed more
frequently than indicated by the data collected and analyzed in the
RAND reports. We continue to be concerned that our current valuations
of the global packages reflect certain E/M visits that are not
typically furnished in the global period, and thus, are not occurring.
We also believe that RAND has adequately responded to critiques of its
methodologies and findings. However, as part of our ongoing assessment
of our data collection process, we continue to welcome any comments
from the public on ideas for other sources of data that would help us
to assess global package valuation (including the typical number and
level of E/M services), as well as our data collection methodology and
the RAND report findings. We received some public comments in our
request for comments on possible additional data sources and on our
data collection methodology. These comments are summarized as follows:
Comment: Some commenters supported the findings and methodology of
the RAND reports. Several commenters stated that the RAND's findings
regarding E/M visit performance aligned with their own anecdotal
observations and experiences. However, other commenters expressed
skepticism of the RAND report findings and methodology, and many urged
us to continue to rely on RUC valuations of global packages (including
the number of embedded E/M visits included in the RUC surveys.) Several
commenters observed that getting truly accurate information from claims
data may be difficult; one commenter pointed out that since work done
by NPPs or clinical staff is often not reported separately, it is
difficult to get a complete picture of postoperative work. As in
previous public discussions, commenters urged CMS to continue to
examine claims data and electronic health records, or obtain
postoperative E/M information through direct surveys of practitioners.
Several commenters noted that we have spent many years performing data
collection in response to the MACRA requirements, and one commenter
requested that we cease our data collection efforts to avoid any
additional burden on practitioner. Many commenters urged us to continue
to work in collaboration with practitioners and other impacted parties
to identify sources of postoperative E/M data and to maintain
transparency about any additional collection efforts.
Response: We found that the comments we received, particularly
those critical of the RAND reports and methodology, echo the feedback
we received several years ago when we shared the RAND reports for
public comment. Please see the discussion of the RAND reports and
findings in the CY 2020 PFS final rule (84 FR 62866) and RAND's
responses to the CY 2020 public comments in the RAND report entitled,
``Responses to Comments on RAND Global Services Reports,'' which is
available at https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/. We note that we
did not receive new data that might either affirm or contradict RAND's
overall findings regarding E/M performance. We agree with commenters'
observations that we have spent many years collecting and analyzing
data regarding E/M performance in response to the MACRA requirements
and other public concerns about the valuation of globals. While we will
continue to evaluate potential sources of data regarding E/M
performance, we agree with commenters who suggest that the overall lack
of transparency within global packages can make identifying the nature
of postoperative care provision difficult and continues to call into
question the accuracy of globals that have been valued through standard
valuation processes.
c. Changes to Health Care Delivery and Payment for E/M Services
Since the inception of the PFS 30 years ago, there have been
significant changes in health care, including improvements in medical
and information technology, new models of health care delivery and
coordination between multiple clinicians furnishing care to a single
patient, and an expanding beneficiary population. (For information on
Medicare service utilization, beneficiary demographics, provider
characteristics, and payment models, please visit the resources at
data.cms.gov.) We asked to hear from the public on whether the
postoperative health care landscape has changed in ways that impact the
relevance of the global packages.
We believe that changes to health care delivery may impact proper
valuation of global services. We solicited comment on whether changes
to health care delivery, including changes in coordination of care and
use of medical technology over the past 3 decades, as well as during
the recent PHE, have impacted: the number and level of postoperative E/
M visits needed to provide effective follow-up care to patients; the
timing of when postoperative care is being provided; and who is
providing the follow-up care. We have formed hypotheses that some
beneficiaries are not receiving the number of postoperative visits that
were contemplated when valuing the global surgical packages or are not
receiving any follow-up E/M visits at all during global periods either
because the physician who performed the surgical procedure has
determined they are unnecessary (perhaps due to improvements in medical
technology or evolution in standards of care) or as the result of more
comprehensive discharge planning. It has also been suggested by some
interested parties that physicians are, in fact, performing the number
of postoperative visits that were contemplated when valuing the global
surgical packages, but the visits may, for various reasons, be
scheduled outside the global period. Others have suggested that
physicians are, without formally transferring follow-up care to another
clinician, instructing patients to follow up with another physician or
NPP (such as the patient's primary care physician or other
practitioner), and that the other clinician then furnishes and bills
for E/M services furnished for postoperative care (whether the care is
performed during or after the global period). We appreciate comments on
these ideas, and on other factors not mentioned here that could affect
the ways that postoperative E/M care is provided.
We also solicited comment on whether, or how, recent changes in the
coding and valuation of separately billable E/M services may have
impacted global packages. One change is the expansion of payment for
non-face-to-face care management services. Historically, an advantage
of global packages was that they compensated physicians for non-face-
to-face work related to the patient's transition from the hospital to
the community, or management of other health care needs following a
procedure or serious illness. Over the years, we have implemented
payment for many care management services to better reflect non-face-
to-face time spent by physicians and clinical staff on behalf of
patients with complex health care needs, including transitional care
management services in CY 2013 (77 FR 68978); chronic care
[[Page 69435]]
management in CY 2015 (78 FR 74414) and CY 2019 (83 FR 58577); complex
chronic care management in CY 2017 (81 FR 80244); and principal care
management in CY 2020 (84 FR 62962). We solicit comment on whether
global packages, and especially those with 10- and 90-day global
periods, continue to serve a purpose when physicians could otherwise
bill separately not only for the postoperative E/M visits they furnish,
but also for aspects of postoperative care management they furnish for
some patients. We also would like to hear generally what, if any,
components of preoperative or postoperative care are currently only
compensated as part of payment for global packages.
We have also heard from some interested parties who believe that
recent changes to the coding and valuation of standalone office and
outpatient E/M visits finalized in the CY 2021 PFS final rule have
skewed the relativity between these visits and the E/M visits included
in the current global package valuations (which were not modified in
response to the coding and valuation changes). In the CY 2020 PFS final
rule (84 FR 62851 through 84 FR 62854), we finalized new--and generally
increased, RVUs for the CPT-revised office and outpatient E/M code set.
Some commenters encouraged us to increase the value of the E/M visits
included in the global surgical packages commensurate with the
increased RVUs for the standalone E/M visits. However, we declined to
do so, noting that at the time that it was unclear whether it would be
appropriate to treat the E/M visits reflected in global packages as
discrete components of the package (in other words, to use a building-
block approach to calculating the value of the service, versus valuing
the services using the more holistic magnitude estimation, or possibly
another approach.) Furthermore, we cited the uncertainty as to whether
the E/M services included in valuing the global packages are typically
furnished as part of global surgery services, reasoning that if the
number and level of E/M services for global packages is not
appropriate, adopting increases in the value of E/M services in global
surgery codes would exacerbate rather than ameliorate any potential
relativity issues. (Refer to the CY 2020 PFS final rule at 84 FR 62856
through 62860 for a complete summary of comments and our responses on
the topic of increasing the value of E/M visits included in the global
packages.) We welcomed additional comments on the perceived
misalignment between the E/M visits included in global packages and
separately billable E/M services, including thoughts on how this
current tension reflects on global payment valuation and the
appropriate methodology for determining appropriate values for global
packages.
We received some public comments on whether changes to health care
delivery and payment for E/M services may impact the performance of E/M
visits or overall relevance of E/M visits. The following is a summary
of the comments we received and our responses.
Comment: Several commenters noted that while patients in general
seem in greater need of critical care, there is also (from various
commenters' perspective) either increasing opportunity or mounting
pressure on practitioners to discharge patients from hospitals and
arrange at-home care after surgeries. Many commenters stated that
postoperative care provided by the proceduralists should still be
considered a best practice. However, a few commenters agreed with some
of our hypotheses--namely that for clinical reasons patients may not
need to return for in-person postoperative care within the global
period, or that scheduling conflicts may make timely return difficult.
A few commenters also agreed that patients may, for reasons of
convenience, receive some postoperative care from community
practitioners rather than returning to the hospital where the surgical
procedure was performed. Some commenters also suggested that there may
be clinical reasons why it is better for a patient to receive
postoperative care from a practitioner or NPP other than the
proceduralist, such as in circumstances when the patient needs long-
term or specialized postoperative care outside the expertise of the
proceduralist. Overall, commenters expressed ambivalence about the
impact the PHE and use of telehealth has had on postoperative care. A
few commenters noted that some aspects of postoperative care--including
sharing of test results or consultations--can be done via telehealth,
while others described types of postoperative care that can only be
done in-person. Commenters also expressed doubt about the impact of
expanded payments for non-face-to-face services, noting that payments
for care management or other non-face-to-face services do not include
all post-surgical conditions and do not address in-person care.
Regarding our questions about the overall relevance of global
packages, some commenters stated that paying for postoperative care as
standalone visits would ensure that Medicare was only paying for the
care that was being delivered. A few commenters suggested that
postoperative care should be not only paid for separately, but paid at
a higher rate. Other commenters stated that global packages continue to
be necessary because they reduce administrative burden on practitioners
and ensure payment of care provided by NPPs and clinical staff.
Response: While we did not receive a great deal of feedback on our
specific request for information as to whether global packages are
still relevant, we believe the information we received demonstrates
that there may be variations in patients' individual postoperative care
needs. While we agree with commenters that in-person visits with the
proceduralist is the standard of care on which global packages were
based, we will continue to examine whether this specific model of
postoperative care is still necessary or relevant for all procedures.
Comment: Many commenters provided input on the valuation of the E/M
visits embedded in global packages as compared to standalone E/M
visits. Although commenters did not provide feedback on whether the
misalignment reflects on the relevance of surgical packages, many
commenters suggested that we should increase the value of global
packages to reflect the increase in standalone E/M visits (both the
office/outpatient increases finalized in CY 2020 at 84 FR 62851 through
84 FR 62854, and increases to certain hospital inpatient E/M visits
proposed in CY 2023 at 87 FR 45993.) Some commenters suggested that the
data collection requirement in the MACRA amendments to the statute does
not preclude CMS from applying such increases to all global packages.
Other commenters, however, agreed with our decision not to increase the
global packages pending our inquiry into the performance of
postoperative E/M visits.
Response: We direct commenters to the CY 2020 PFS final rule (84 FR
62851 through 84 FR 62854), where we discussed similar concerns. We
continue to disagree with commenters' interpretation of the MACRA
amendments. We note that section 1848(c)(8) of the Act, as amended by
section 523(a) of the MACRA (Pub. L. 110-14), directs CMS to use the
information collected to improve the accuracy of valuation of these
services specifically requires that we use the data we obtain through
data collection to revalue the global packages. Our data currently
suggests that at least some global packages are inaccurately, revalued,
and until we identify data that demonstrates otherwise, we do not
believe it would be appropriate to apply
[[Page 69436]]
an across-the-board adjustment to the packages that is not supported by
data. Additionally, we are also working to reconcile public
recommendations that we revalue global packages on a holistic or case-
by-case basis (discussed in greater detail in section II.B.6.d. of this
final rule) with recommendations that we apply across-the-board
increases to all global packages.
d. Strategies To Address Global Package Valuation
Consistent with the discussion above, we continue to believe that:
(1) there is strong evidence suggesting that the current RVUs for
global packages are inaccurate; (2) many interested parties agree that
the current values for global packages should be reconsidered, whether
they believe the values are too low or too high; and (3) it is
necessary to take action to improve the valuation of the services
currently valued and paid under the PFS as global surgical packages.
We would like to re-engage with the public about whether the global
packages are indeed misvalued, and if so, what would be an appropriate
approach to valuation. We have previously sought assistance from the
public on possible methods of revaluation, such as in the CY 2015 PFS
final rule (79 FR 67586).
As noted in the ``Data Collection, Analysis, and Findings'' section
above (section II.B.6.b.), RAND has provided a comprehensive roadmap
for a possible revaluation strategy. (See specifically the RAND report,
``Using Claims-Based Estimates of Postoperative Visits to Revalue
Procedures with 10- and 90-Day Global Periods,'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-. We solicited
additional input on the RAND methodology, including advantages and
drawbacks of applying the RAND methodology to revaluation (in addition
to previous feedback that was provided by the public in the CY 2020 PFS
final rule at 84 FR 62867). We also requested input on specific
alternatives, including: (1) requesting the RUC to make recommendations
on new values; or (2) another method proposed by the public.
We solicited feedback from the public on possible strategies for a
revaluation process for global services. We believe that the available
information provided in the RAND reports (discussed in section
II.B.6.b. of this final rule and available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-) indicates that there is a mismatch between
the value of the global package and work being performed. In
particular, it appears that for some services, the number of
postoperative visits typically furnished by the billing physician is
much lower than what was reflected in the global package value, and
thus we believe it may be necessary to revalue those services. (As
noted in section II.B.6.b. of this final rule, RAND's analysis found
that the reported number of E/M visits matched the expected E/M visits
for only 4 percent of reviewed 10-day global packages and 38 percent of
reviewed 90-day global packages. We referred specifically to the RAND
report, ``Claims-Based Reporting of Postoperative Visits for Procedures
with 10- or 90-Day; Global Periods--Updated Results Using Calendar Year
2019 Data'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-).
Because there are a large number and volume of services paid as global
packages, we must consider the resources needed to revalue even a
subset of the global packages, as well as the impacts across the PFS
and healthcare delivery system in general if we were to change the
values of a significant number of services at one time. We considered
various approaches we could pursue, such as: (1) revaluing all 10- and
90-day global packages at one time (perhaps with staggered
implementation dates); (2) revaluing only the 10-day global packages
(because these appear to have the lowest rate of postoperative visit
performance, per RAND's analysis of claims data); (3) revaluing 10-day
global packages and some 90-day global packages (such as those with
demonstrated low postoperative visit performance rates as identified in
RAND's analysis of these services); or (4) relying on the Potentially
Misvalued Code process to identify and revalue misvalued global
packages over the course of many years. (We noted that regardless of
whether we review particular global packages as part of a specific
revaluation strategy, the public may always nominate any global
packages to be reviewed through the Potentially Misvalued Code process;
refer to the description of the Potentially Misvalued Code process in
section II.C. of this final rule.) We solicited comment on any of the
strategies identified in this paragraph, as well as any additional
ideas members of the public may have that would address the concerns
described above about valuation of global packages. We also solicited
comment on ancillary considerations including timing considerations for
implementation of any future strategy (such as whether to have
staggered effective dates for new valuations and what criteria to use
if assigning staggered effective dates.)
We also solicited comment on additional considerations affecting
valuation of global services that may not have been thoroughly explored
in previous public comment opportunities. For instance, we are aware
that some interested parties are concerned that not enough attention
has been paid to the value of preservice work bundled into the global
payment, which could affect accurate valuation of 10- and 90-day global
packages, as well as the value of the service if it is transitioned to
a 0-day global. We solicited additional information about this concern,
as well as any other concerns about valuation not otherwise mentioned
here.
We received public comments on strategies to address global package
valuation. The following is a summary of the comments we received and
our responses.
Comment: Some commenters agreed that global surgical packages are
misvalued and encouraged CMS to revalue the packages in order to reduce
the impacts of improper valuation on the relative value scale. A few
commenters agreed that packages were misvalued, but suggested we
continue to work with impacted parties to find a method for
revaluation. Other commenters stated that they do not believe that
global packages were misvalued or, if they are misvalued, they should
be revalued on a holistic and case-by-case basis using the RUC process
or the Potentially Misvalued Code process. A few commenters suggested
that CMS and the RUC collaborate on a specific method to revalue global
packages. Commenters also noted that revaluing through the RUC process
could take a number of years and may present resource challenges.
We received diverse comments on approaches for revaluing the codes,
including revaluing all 10- and 90-day packages, revaluing some 10- and
90-day packages, or focusing just on the 10-day packages. Commenters
who recommended focusing on the 10-day packages suggested that this
would address services with lower demonstrated postoperative E/M visit
rates, and would provide us with insight about revaluation that could
then be applied to the 90-day packages as needed. Other commenters made
suggestions including phasing out global packages by not valuing new
CPT codes as globals, or changing the length
[[Page 69437]]
of global periods. While one commenter was in favor of revaluing all
packages at one time, many commenters suggested revaluing over a number
of years to avoid too much disruption to the relative value scale. One
commenter suggested we wait until after the conclusion of the PHE to
revalue any packages.
Response: We believe that the spectrum of comments demonstrates
that there is not, at this time, clear public consensus on this issue
or the preferred strategy for valuing globals. We will consider the
specific strategies proposed by the commenters and the concerns
regarding impact on the relative value scale and the resources that
would be required to revalue these codes.
e. Other Payment Structure Changes, Unintended Consequences, and
Missing Information
We solicited public comment on any other aspects of the global
payment structure (aside from the valuation of services) that
commenters believe are noteworthy. Much of the discussion over the
years has focused on whether global surgical packages are properly
valued and whether they are needed at all. We encourage commenters to
point out ways in which global surgical packages may continue to have a
positive impact on health care delivery (such as their potential to
support innovation). We also solicited suggestions on other ways that
global surgical package payments could be modified (aside from changing
their valuation) that could help improve accurate valuation or help
address other concerns about the payments (such as the lack of
transparency about what care is being provided as part of the package).
We also requested comment on additional information that we may not
have considered or discussed above about proper valuation of the global
packages, as well as any unintended impacts (or positive outcomes) that
could result from changes to how we value global services. We are
especially interested in public comment on any concerns about
beneficiaries' access to care, continuity of care, cost sharing, or
program integrity.
We received limited public comments on other payment structure
changes, unintended consequences, and missing information. The
following is a summary of the comments we received and our responses.
Comment: A few commenters opined on the consequences of unbundling
global payments. A few of these commenters raised concerns that
unbundling the packages would reduce payments to physicians or NPPs. A
few expressed concerns that beneficiaries might not want to pay the
coinsurance for standalone E/M visits (should global packages be
unbundled) and might decline postoperative care.
Response: We agree that the payments to practitioners might change
in circumstances where globals are revalued, although we do not believe
there is yet enough information to determine the financial impact
should proceduralists bill separately for postoperative care for some
procedures. We will continue to consider the potential impact of
coinsurance for globals and postoperative care for beneficiaries.
After consideration of the comments, we wish to thank the
commenters for their input. As outlined in the proposed rule, this
discussion has spanned over a decade, with participation from specialty
societies, advocacy groups, program integrity agencies, and Congress.
We had hoped through this comment solicitation to nudge discussion into
new or under-explored lanes of inquiry that would help us better
understand how global packages fit into the current health care
landscape. We appreciate the engagement we did receive with our
requests for information regarding current health care practices.
Additionally, numerous interested parties, those who have been engaged
with the discussion for many years, as well as some new voices,
provided comment that reinforced or reiterated concerns that have
emerged in prior discussions.
In this year's comment solicitation, we received a spectrum of
perspectives on: whether the globals are misvalued; if misvalued,
whether they are undervalued or overvalued; whether we should continue
to value them through our current processes or develop a new
methodology that better addresses the unique challenges posed by
bundled payments; and whether globals should be revalued individually,
in batches, or in their entirety. Looking at the totality of the
comments and keeping in mind discussion from prior years, we have
identified a few common themes on which many seem to agree. The matter
of global valuation is complex. Global packages comprise a large number
of codes, and their valuation has a significant impact on the PFS
relative value scale. Accurately valuing the work and other inputs of
the globals is critically important to ensure not only that the
practitioners providing those services are paid accurately for the work
performed, but that there is no inequitable impact on practitioners
paid outside of 10- and 90-day global packages. The diversity of
procedures paid under global packages may mean that blanket approaches
to valuation or revaluation may not achieve the desired degree of
accuracy. And, finally, while universally agreed-upon data strategies
may prove elusive, good data analysis is a critical foundation on which
to base any method for valuing these packages. We appreciate the
public's engagement on this issue, and continue to welcome additional
insights from interested parties as we consider appropriate next steps.
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the relative
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to periodically identify potentially
misvalued services using certain criteria and to review and make
appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop
a process to validate the RVUs of certain potentially misvalued codes
under the PFS, using the same criteria used to identify potentially
misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this final rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), MedPAC, and other interested parties. For many
years, the RUC has provided us with recommendations on the appropriate
relative values for new, revised, and potentially misvalued PFS
services. We review these recommendations on a code-by-code basis and
consider these recommendations in conjunction with analyses of other
data, such as claims data, to inform the decision-making process as
authorized by statute. We may also consider analyses of work time, work
RVUs, or direct PE inputs using other data sources, such as Department
of Veteran Affairs (VA), National Surgical Quality Improvement Program
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based
Incentive Payment System (MIPS) data. In addition to considering the
most recently available data, we assess the
[[Page 69438]]
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also considered information provided
by other interested parties. We conducted a review to assess the
appropriate RVUs in the context of contemporary medical practice. We
note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of
extrapolation and other techniques to determine the RVUs for
physicians' services for which specific data are not available and
requires us to take into account the results of consultations with
organizations representing physicians who provide the services. In
accordance with section 1848(c) of the Act, we determine and make
appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/Fee-for-Service-Payment/Physiciandefault-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed the importance of
appropriately valuing physicians' services, noting that misvalued
services can distort the market for physicians' services, as well as
for other health care services that physicians order, such as hospital
services. In that same report, MedPAC postulated that physicians'
services under the PFS can become misvalued over time. MedPAC stated,
``When a new service is added to the physician fee schedule, it may be
assigned a relatively high value because of the time, technical skill,
and psychological stress that are often required to furnish that
service. Over time, the work required for certain services would be
expected to decline as physicians become more familiar with the service
and more efficient in furnishing it.'' We believe services can also
become overvalued when PE costs decline. This can happen when the costs
of equipment and supplies fall, or when equipment is used more
frequently than is estimated in the PE methodology, reducing its cost
per use. Likewise, services can become undervalued when physician work
increases or PE costs rise.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time-period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period (76 FR 73026, 73058 through 73059),
other individuals and groups submit nominations for review of
potentially misvalued codes as well. Individuals and groups may submit
codes for review under the potentially misvalued codes initiative to
CMS in one of two ways. Nominations may be submitted to CMS via email
or through postal mail. Email submissions should be sent to the CMS
emailbox at [email protected], with the phrase
``Potentially Misvalued Codes'' and the referencing CPT code number(s)
and/or the CPT descriptor(s) in the subject line. Physical letters for
nominations should be sent via the U.S. Postal Service to the Centers
for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security
Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination
letters must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes.'' Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 1,700
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior
[[Page 69439]]
reviews of potentially misvalued codes is included in the CY 2012 PFS
final rule with comment period (76 FR 73052 through 73055). In the same
CY 2012 PFS final rule with comment period, we finalized our policy to
consolidate the review of physician work and PE at the same time, and
established a process for the annual public nomination of potentially
misvalued services.
In the CY 2013 PFS final rule with comment period (77 FR 68892,
68896 through 68897) we built upon the work we began in CY 2009 to
review potentially misvalued codes that have not been reviewed since
the implementation of the PFS (so-called ``Harvard-valued codes''). In
the CY 2019 PFS proposed rule (73 FR 38589), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review of Work RVUs
proposed rule (76 FR 32410, 32419), we requested recommendations from
the RUC to aid in our review of Harvard-valued codes with annual
utilization of greater than 30,000 services. In the CY 2013 PFS final
rule with comment period, we identified specific Harvard-valued
services with annual allowed charges that total at least $10,000,000 as
potentially misvalued. In addition to the Harvard-valued codes, in the
CY 2013 PFS final rule with comment period we finalized for review a
list of potentially misvalued codes that have stand-alone PE (codes
with physician work and no listed work time and codes with no physician
work that have listed work time). We continue each year to consider and
finalize a list of potentially misvalued codes that have or will be
reviewed and revised as appropriate in future rulemaking.
3. CY 2023 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67548,
67606 through 67608), we modified this process whereby the public and
interested parties may nominate potentially misvalued codes for review
by submitting the code with supporting documentation by February 10th
of each year. Supporting documentation for codes nominated for the
annual review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In each year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In each proposed rule, we seek nominations from the public and from
interested parties of codes that they believe we should consider as
potentially misvalued. We receive public nominations for potentially
misvalued codes by February 10th and we display these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. We sometimes receive
submissions for specific, PE-related inputs for codes, and discuss
these PE-related submissions, as necessary under the Determination of
PE RVUs section of the rule. We summarize below this year's submissions
under the potentially misvalued code initiative.
An interested party nominated the home-based physician visit codes:
CPT code 99344 (Home visit for the evaluation and management of a new
patient, which requires these 3 key components: A comprehensive
history; A comprehensive examination; and Medical decision making of
moderate complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting problem(s) are of high
severity. Typically, 60 minutes are spent face-to-face with the patient
and/or family), CPT code 99345 (Home visit for the evaluation and
management of a new patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the patient is
unstable or has developed a significant new problem requiring immediate
physician attention. Typically, 75 minutes are spent face-to-face with
the patient and/or family), CPT code 99349 (Home visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A detailed interval history; A
detailed examination; Medical decision making of moderate complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are moderate to high
severity. Typically, 40 minutes are spent face-to-face with the patient
and/or family), and CPT code 99350 (Home visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A comprehensive interval history; A
comprehensive examination; Medical decision making of moderate to high
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting
[[Page 69440]]
problem(s) are of moderate to high severity. The patient may be
unstable or may have developed a significant new problem requiring
immediate physician attention. Typically, 60 minutes are spent face-to-
face with the patient and/or family) as potentially misvalued.
In their submission, the nominator expressed concern that there is
no payment for transportation costs incurred when it is medically
necessary for a physician to drive to the home of the patient for a
face-to-face in-home E/M Visit, and that they are not compensated for
opportunity loss they incur by seeing fewer patients because they spend
time commuting to patients' homes, versus seeing more patients that
come to their offices. The nominator also argued that Medicare does not
compensate physicians for the work and time associated with assessing a
patient's home environment, which provides insight into a patient's
overall health and living conditions. The nominator collectively called
these non-medical factors that can affect a patient's overall health
the ``Social Determinants of Health'' (SDoH). The nominator requested
that we increase the overall RVUs for CPT codes 99344, 99345, 99349,
and 99350, by including the resources associated with: (1) the
physician's transportation costs to patients' homes; (2) lost income
opportunity for home versus in-office visits; and (3) in-home SDoH
assessment work. The nominator estimated that the adjustments to RVUs
to reflect transportation costs and opportunity costs would result in a
Medicare payment that is 67 percent higher than the current Home-based
E/M Visits payment rates, and that adjustments to account for the
physician's SDoH assessment would add an additional 55 percent increase
to the payment rates for Home-based E/M Visits. In total, the nominator
suggests that if these resources were taken into account, the payment
rates for Home-based E/M CPT codes would increase by what the nominator
estimates as a 222 percent increase from their current amounts.
The nominator included references as evidence to support their
claim that the home-based E/M CPT codes are potentially misvalued, such
as the CMS ``Medicaid Non-Emergency Medical Transportation Booklet for
Providers'' (April 2016) 6 7 and a press release from the
Better Medicare Alliance entitled, ``Report Shows Dramatic Increase in
Medicare Advantage Activity to Address Social Determinants of Health,
But Barriers Remain''.\8\
---------------------------------------------------------------------------
\6\ https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/nemt-booklet.pdf.
\7\ https://storage.aanp.org/www/documents/NP-Infographic.pdf.
\8\ https://bettermedicarealliance.org/news/report-shows-
dramatic-increase-in-medicare-advantage-activity-to-address-social-
determinants-of-health-but-barriers-remain/
#:~:text=Social%20determinants%20of%20health%20are,to%20the%20World%2
0Health%20Organization.
---------------------------------------------------------------------------
We noted that the nominator did not nominate the entire family of
home-based E/M visit codes (please see Table 9 for a list of home-based
E/M codes).
[GRAPHIC] [TIFF OMITTED] TR18NO22.011
When we establish values for codes or consider whether codes are
potentially misvalued under the PFS, we take into account the resources
involved in furnishing the specific service as described by the CPT
code. As such, historically, we do not take into account: (1) travel
costs incurred by the physician or other practitioner; (2) potential
opportunity costs to a physician or other practitioner when care is
delivered in one setting versus another; or (3) the physician or other
practitioner's work and time expended in performing activities that are
outside the scope of the specific service as described by the CPT code.
These are not considered to be resources involved in furnishing the
service, and they are not included in establishing payment rates under
the PFS in accordance with section 1848 of the Act, and, as such, do
not provide justification for potential misvaluation of those payments.
That said, in February 2021, the AMA CPT Editorial Panel deleted the
family of domiciliary codes, CPT codes 99324 to 99340, and merged the
services described by those codes into the existing family of home-
based E/M visits, CPT codes 99341 to 99350 (a range of codes that
includes CPT codes 99344, 99345, 99349, and 99350). In addition, the
AMA RUC made recommendations regarding the values for these home-based
E/M codes as discussed in section II.F. of the CY 2023 PFS proposed
rule (87 FR 45999) and in section II.F. of this final rule. Since CMS
had already received AMA RUC recommendations for these home-based E/M
visit codes, we considered those recommendations and solicited
additional public comments, recommendations, and independent analysis
as supporting evidence from all interested parties regarding the
valuations for the home-based E/M visits, including CPT codes 99344,
99345, 99349, and 99350. Because we discussed and solicited public
comment on the valuation of these codes in the proposed rule, we stated
that we were not considering these home-based E/M
[[Page 69441]]
visits as potentially misvalued for CY 2023.
An interested party has nominated the following cataract surgery
codes, CPT codes 65820 (Goniotomy--Incision to improve eye fluid flow),
66174 (Transluminal dilation of aqueous outflow canal; without
retention of device or stent), 66982 (Complex Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification), 66984 (Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification)), 66989 (Complex Extracapsular
cataract removal w/IOL insertion, complex; with insertion of
intraocular (e.g., trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without extraocular
reservoir, internal approach, one or more), and 66991 (Extracapsular
cataract removal w/IOL insertion; with insertion of intraocular (e.g.,
trabecular meshwork, supraciliary, suprachoroidal) anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, one or more), as well as the following retinal procedure
codes, CPT codes 67015 (Aspiration or release of vitreous, subretinal
or choroidal fluid, pars plana approach (posterior sclerotomy)), 67036
(Vitrectomy, mechanical, pars plana approach), 67039 (Vitrectomy,
mechanical, pars plana approach; with focal endolaser
photocoagulation), 67040 (Vitrectomy, mechanical, pars plana approach;
with endolaser panretinal photocoagulation), 67041 (Vitrectomy,
mechanical, pars plana approach; with removal of preretinal cellular
membrane (e.g., macular pucker)), 67042 (Vitrectomy, mechanical, pars
plana approach; with removal of internal limiting membrane of retina
(e.g., for repair of macular hole, diabetic macular edema), includes,
if performed, intraocular tamponade (i.e., air, gas or silicone oil)),
67043 (Vitrectomy, mechanical, pars plana approach; with removal of
subretinal membrane (e.g., choroidal neovascularization), includes, if
performed, intraocular tamponade (i.e., air, gas or silicone oil) and
laser photocoagulation), 67108 (Repair of retinal detachment; with
vitrectomy, any method, including, when performed, air or gas
tamponade, focal endolaser photocoagulation, cryotherapy, drainage of
subretinal fluid, scleral buckling, and/or removal of lens by same
technique), and 67113 (Repair of complex retinal detachment (e.g.,
proliferative vitreoretinopathy, stage C-1 or greater, diabetic
traction retinal detachment, retinopathy of prematurity, retinal tear
of greater than 90 degrees), with vitrectomy and membrane peeling,
including, when performed, air, gas, or silicone oil tamponade,
cryotherapy, endolaser photocoagulation, drainage of subretinal fluid,
scleral buckling, and/or removal of lens), as potentially misvalued
because there is currently no established non-facility payment rate for
these global 090-day surgical procedures. These codes are complex
surgical eye procedures, and they require dedicated spaces, similar to
facility-based spaces that are not typically found in an
ophthalmologist's office--such as a well-lighted and sterile surgical
theater; specific eye surgery equipment; and, possibly, clinical staff
and other medical personnel trained to assist in these surgeries and
the patient's immediate post-surgery recovery, including anesthesia
services. In the past, with concerns for patient safety and given the
intricate and delicate nature of these surgeries, we understood that
these procedures would only be performed in a well-equipped and fully
staffed medical facility. For Medicare Part B, payment for these
services is only made for procedures furnished in the facility
settings, but this nominator suggests that these cataract and retinal
procedures can be properly performed in the non-facility office,
safely, effectively, and perhaps more conveniently for patients and
physicians; and thus requests that we should establish non-facility
RVUs under the PFS to recognize the additional resources that would be
expended in the non-facility setting.
The nominator has included a list of practice expense (PE) items
involved in furnishing these services in the non-facility setting to
help us to consider establishing non-facility values for these codes.
They include the possible number and types of clinical staff and their
work time in minutes as well as a list of various equipment and
supplies typically needed to furnish the services described by the
nominated codes.
The nominator also noted that there is projected backlog for these
cataract and retinal services that may have been building up due to the
COVID-19 restrictions from the past 2 years. We solicited comment on
the merits of continuing to value these codes only in the facility
setting, as opposed to also establishing non-facility values for these
cataract and retinal surgery codes. We also solicited comment on any
appropriate safety considerations for these codes in the non-facility
setting, and whether these codes are potentially misvalued. We noted
that in last year's CY 2022 PFS final rule with comment (86 FR 65096
through 65097), we did review CPT codes 66982, 66984, 66987, 66988,
66989, 66991, and 0671T (Cataract Removal with Drainage Device
Insertion) and did not establish non-facility values for those
services, but we did note a potential rank order anomaly when
considering minimally invasive glaucoma surgeries (MIGS) and cataract
surgeries together, and suggested that the AMA RUC should consider re-
surveying all of the codes in this family.
An interested party nominated add-on CPT code 20931 (Allograft,
structural, for spine surgery only (List separately in addition to code
for primary procedure)) as a potentially misvalued service with respect
to the physician's labor for spinal surgeries involving the use of
biomechanical synthetic cage devices versus the use of structural
allograft bone as it relates to a set of CPT codes related to anterior
cervical discectomy and fusion (ACDF). Ordinarily, interested parties
nominate a primary service code as potentially misvalued, or a primary
service code and its related add-on codes, but not an add-on code
alone. The valuation of an add-on code is typically developed with
reference to some portion of the work (or other resource inputs)
involved in furnishing the primary service code. For example, the AMA
CPT 2022 Professional Edition, page 147, states ``Use code 20931 in
conjunction with codes 22319, 22532-22533, 22548-22558, 22590-22612,
22630, 22633, 22634, 22800-22812''. The primary spinal surgery codes
and the add-on CPT code 20931 have not been recently reconsidered or
reviewed by the AMA RUC or CMS, and no new or additional information
has been included with this nomination to persuade CMS that CPT code
20931 is individually potentially misvalued. This nomination of an add-
on code as potentially misvalued is similar to the nomination we
discussed in the CY 2022 PFS proposed rule (86 FR 65044) of CPT code
22551 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2) and the accompanying add-on
codes.
The nominator refers to two different methods of vertebral fusion:
one using biomechanical synthetic cage devices, the other using
structural allograft bone; and describes a typical vertebral fusion
case that uses three units of one of these products. Both of these
methods of vertebral fusion are described by CPT
[[Page 69442]]
code 22551 (includes a 90-day global period), which has a work RVU of
25.00. Both methods of vertebral fusion also involve two units of CPT
code 22552 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2, each additional interspace
(List separately in addition to code for primary procedure)), which
have a total work RVU of 13.00 (6.50 x 2), and 1 unit of CPT code 22846
(Anterior instrumentation; 4 to 7 vertebral segments (List separately
in addition to code for primary procedure)), which has a work RVU of
12.40. The vertebral fusion method employing three synthetic cage
devices with plate would involve three units of CPT code 22853
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage,
mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to intervertebral disc space
in conjunction with interbody arthrodesis, each interspace (List
separately in addition to code for primary procedure)) for a total work
RVU of 12.75 (4.25 x 3), and one unit of CPT code 20930 (Allograft,
morselized, or placement of osteopromotive material, for spine surgery
only (List separately in addition to code for primary procedure)) with
a work RVU of 0.00 (because Medicare considers this code to be bundled
into codes for other services). The nominator states that the typical
vertebral fusion employing three synthetic cage devices with plate
would total to 63.15 work RVUs.
In contrast, the nominator asserts that the vertebral fusion method
employing structural allograft bones with plate involves the same set
of services and codes (that is, one unit of CPT code 22551, two units
of CPT code 22552, and one unit of CPT code 22846), but the structural
allograft bone method includes CPT code 20931 (Allograft, structural,
for spine surgery only (List separately in addition to code for primary
procedure)), with a work RVU of 1.81, instead of CPT codes 22853 and
20930, for a total work RVU of 52.21. The nominator suggests that this
difference in total work RVUs for the two methods of vertebral fusion,
63.15 versus 52.21, is evidence that add-on CPT code 20931 is
potentially misvalued; however, we do not agree with this nominator's
method of aggregating and comparing sums of work RVUs for groups of
services that may be furnished together as being potentially misvalued,
nor consider CPT code 20931 as the source of misvaluation within this
grouping.
We understand that the nominator believes there should be an
equivalent total sum payment for all services involved in vertebral
fusion surgeries using either method, and that there should not be a
potential incentive for physicians to prefer the method that uses
synthetic cage devices because of the higher available payment amount.
The nominator asserts that the total sum payment for this kind of
spinal surgery using the structural allograft bone method is
undervalued as compared to the total sum payment for this kind of
spinal surgery using the synthetic cage method.
We note that CPT code 22853, which the commenter associates with
the synthetic cage device method of vertebral fusion, is a 45-minute
ZZZ-code (indicating an add-on code) with an IWPUT (intra-service work
(RVU) per unit of time) of 0.0944, whereas CPT code 20931, which the
commenter associates with the allograph method of vertebral fusion, is
a 20-minute ZZZ-code with an IWPUT of 0.0905. Given the much longer
intra-service time and greater IWPUT for CPT code 22853 than for CPT
code 20931, the allograph method of vertebral fusion would be expected
to have a lower total sum of work RVUs.
The nominator's description of why and how each vertebral fusion
method is potentially misvalued when compared to the other does not
present a situation that fits within our process for identifying
individual services that are potentially misvalued using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to individual
codes, or with the inter-code relativity between the RVUs assigned to
several individual codes found within a family of codes with
hierarchical relationships. We generally do not examine the summed
differences in total RVUs (as is the case presented here), based on
billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator has
provided sufficient evidence to demonstrate that CPT code 20931 itself
is misvalued, and therefore, we are not inclined to propose this code
as potentially misvalued; however, we solicited additional comment and
any independent analysis and studies (see the supporting documentation
options listed above under ``CY 2023 Identification and Review of
Potentially Misvalued Services,'' particularly in regard to any changes
in the resources to providing a service) as supporting evidence from
commenters in agreement or disagreement with this nomination.
See Table 10 for the listing of nominated potentially misvalued
codes.
[[Page 69443]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.012
We received public comments on our discussion of public nominations
for potentially misvalued codes and decision not to propose them as
potentially misvalued. The following is a summary of the comments we
received and our responses.
We received a number of public comments on the nominated home-based
E/M visit CPT codes 99344, 99345, 99349, and 99350.
Comment: Commenters were disappointed, stating that CMS did not
take into account the inclusion of the nominator's request for
consideration for: (1) travel costs incurred by the physician or other
practitioner; (2) potential opportunity costs to a physician or other
practitioner when care is delivered in the patient's home versus in the
office or at a facility; or (3) the physician or other practitioner's
work and time expended assessing a patient's home environment and/or
``Social Determinants of Health'' (SDoH) assessments. Commenters
explained that the typical home-bound patient, who requires a physician
home visit, is comparatively more frail, with multiple chronic
conditions. Some commenters suggested add-on codes, similar to the
codes for at-home COVID-19 Vaccinations, for physician transportation
costs to the patient's home.
Response: We appreciate the feedback from commenters and encourage
further discussion as we gain more experience with the new codes. As
discussed in our proposed rule, the costs identified by commenters are
not considered to be specific work, practice expense, or malpractice
expense resource inputs that are taken into account in valuation of
individual services under the PFS, so they are not included in
establishing payment rates under the PFS in accordance with section
1848 of the Act. As such, these costs do not provide justification for
potential misvaluation of the identified codes. We also noted in the CY
2023 PFS proposed rule (87 FR 45883) that the AMA RUC made
recommendations regarding the values for these home-based E/M visit
codes. Since CMS had already received AMA RUC recommendations for these
home-based E/M visit codes for this year's proposed rule, we referred
readers to the discussion and solicitation of public comments on those
recommendations in the proposed rule. We solicited additional public
comments, recommendations, and independent analysis as supporting
evidence from all interested parties regarding the valuations for the
home-based E/M visits, including CPT codes 99344, 99345, 99349, and
99350. We refer readers to section II.F. of this final rule for a
summary and our responses to those comments. With regard to the
comments requesting additional coding, we appreciate commenters'
suggestions, and, as we gain information from utilization of the newly-
reviewed codes and receive additional feedback from interested parties,
we may consider changes in future rulemaking.
Comment: One commenter stated that his Home Visit PEs are not lower
than those of an office practice, but did not offer any code-level
details to support this statement.
Response: We appreciate the perspective of interested parties, but
we would need code-level PE details to evaluate potential code
valuation issues.
We received numerous comments on the Cataract and Retinal Surgery
codes which were nominated as potentially misvalued with a request to
establish nonfacility payment rates for these complicated 090-day
global surgical procedures.
Comment: Several commenters requested that CMS revise the current
work RVU for CPT code 66174 (Transluminal dilation of aqueous outflow
canal; without retention of device or stent) and instead use the
[[Page 69444]]
higher AMA RUC-recommended work RVU value or, short of that, transition
the valuation we established in the CY 2022 PFS final rule over 3
years.
Response: We thank commenters for this comment. CPT code 66174 was
reviewed and finalized in last year's rule (85 FR 65095), and we will
not consider this code as potentially misvalued for CY 2023. We did not
identify or propose CPT code 66174 as potentially misvalued in the
proposed rule. As such, this comment is outside the scope of the
proposed rule.
Comment: Many commenters recounted the evolution of these Cataract
and Retinal Surgery codes--once exclusively performed in hospital
operating theaters, then performed in ASCs, and now perhaps maturing
into the next phase of eye care and Office-Based Surgeries (OBS).
Commenters were mainly in favor of establishing payment amounts for
these services in the non-facility office setting, which would
recognize the additional PE resources involved in furnishing the
services in those settings. Commenters also stated that there are
significant advantages to be gained when these cataract and retinal
surgery services are furnished in non-facility office settings. OBS may
offer faster scheduling and coordinating with the surgeon, patient, and
patient's family caretaker, since they bypass additional schedule
coordination, and avoid potential staffing or availability issues with
the hospital or ASC operating room. These commenters suggested that
scheduling activities may be more efficient and flexible in the OBS
setting, leading to fewer and shorter delays in delivering these
Cataract and Retinal Surgeries to alleviate the patient's urgent eye
problem (especially during recent COVID-19-related restrictions). The
commenters also suggested that office-based surgical staff are also
more likely to be familiar to the patient than a hospital operating
room or ASC staff. One commenter offered that organizations, such as
the American Association for Accreditation of Ambulatory Surgery
Facilities (AAAASF), may offer accreditation for practitioners
interested in furnishing OBS for these services, to prove they can
demonstrate they have adequate equipment, adequate sterility, adequate
backup power and lights, adequate clinical surgery personnel, and
adequate emergency personnel, should there be a need for them, compared
to hospital operating rooms or ASCs, possibly maintaining
certifications with periodic re-inspections.
Some Hospital/ASC-based commenters noted that, after decades of
ophthalmologist experience with these Cataract and Retinal Surgery
codes, they had a number of concerns about these services shifting
toward office-based surgeries compared with Hospital/ASC settings and
whether OBS can adequately address these concerns, including: (1)
Sterility controls equal or better than a hospital operating room or a
dedicated ASC operating theater; (2) Anesthesia for the OBS that is
different in the office where valium oral sedation may be used and the
patient being monitored by the physician eye surgeon, rather than in an
O.R. with general sedation via IV administered and monitored by an
anesthesiologist; (3) Equipment quality and maintenance is a concern
and in the smaller typical office setting, there may not be the backups
and redundancies that may be found in the larger facility settings,
with automatic emergency power switchovers that may not be installed
for the OBS; (4) Patient complications being detected in the pre-
screening phase, possible complications occurring during the surgical
procedure phase, and possible complications during the post-procedure
phase, are concerns for the OBS, which may not have the full facility
resources to address emergency situations arising from the office based
surgery; (5) Staff for OBS are likely to be well familiar with eye
surgeries and the patients themselves, but a general O.R. or ASC staff
might be more experienced in responding to a wider range of surgical
related complications; (6) The intricate, delicate, and complicated
surgical procedures performed by varying experienced eye surgeons
remains a concern when these procedures are performed outside of a full
facility operating theater; (7) There is considered by some commenters
to be a paucity of independent, high-quality, peer-reviewed clinical
data supporting the safety or feasibility of retina surgery performed
in an office setting, nor do they believe that there is any widespread
demand by retina specialists or patients for this OBS option.
Response: We appreciate commenters' perspectives regarding their
experience and concerns for Cataract and Retinal Surgeries being
furnished as OBS. As we continue to consider how and where these
services are furnished, and whether they are typically furnished in
different settings, information such as the comments provided by these
and other commenters are helpful. Based upon commenters' feedback, we
have concerns about these services being furnished in non-facility
settings. It is also unclear whether these services are routinely being
furnished outside of facility settings. CMS will continue to evaluate
whether these services are being furnished in non-facility settings and
will consider establishing non-facility values for these services at
that time.
Comment: The AMA RUC commented that it defers to the ophthalmology
and retinal specialty societies to determine whether these services
could be safely performed in the non-facility setting; the specialty
societies recommend against CMS moving forward with making these
services payable as OBS, citing many of the same commenters' concerns
listed earlier in this section.
Response: We appreciate the AMA RUC's response to this issue,
explaining that they defer to the specialty societies' position on this
issue.
After consideration of public comments, we will continue to gather
information concerning Cataract and Retinal Surgeries in the non-
facility office settings and their implications to Medicare payment for
future rulemaking.
We received a few public comments on the nominated CPT code 20931
(Allograft, structural, for spine surgery only (add-on code)) and other
codes related to anterior cervical discectomy and fusion (ACDF).
Comment: One commenter agreed with the nominator that CPT code
20931 is misvalued when compared to CPT code 22853 (Insertion of cage
or mesh device to spine bone and disc space during spine fusion (add-on
code)) and other codes related to anterior cervical discectomy and
fusion (ACDF), where the higher payment for CPT code 22853
inappropriately incentivizes surgeons to insert the synthetic cage
spacer over the bone allograft. However, one commenter stated that
there is no evidence that CPT code 20931 is misvalued, and that the
valuation of CPT code 20931 should not be equivalent to CPT code 22853.
Response: We thank these commenters for their feedback. As this
nomination is almost identical to a grouping of related codes for ACDF
that had been presented in the CY 2022 PFS proposed rule (86 FR 65044),
under CPT code 22551 as misvalued, and as it was discussed at that time
and reviewed again in this rule, we do not believe that the nominator
has provided sufficient evidence to demonstrate that CPT code 20931 is
misvalued nor that this code's payment should be made equivalent to CPT
code 22853. As stated earlier, our determination that one or more codes
are potentially misvalued generally revolves around the specific RVUs
assigned to individual codes, or with the inter-code relativity between
the
[[Page 69445]]
RVUs assigned to several individual codes found within a family of
codes with hierarchical relationships. We generally do not examine the
summed differences in total RVUs (as is the case presented here), based
on billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator or other
interested parties have provided sufficient evidence to demonstrate
that CPT code 20931 itself is misvalued, and therefore, we are not
inclined to propose (or adopt) this code as potentially misvalued.
After consideration of public comments, we are finalizing our
proposal not to adopt any of the nominated codes as potentially
misvalued codes. We encourage commenters who wish to nominate codes as
potentially misvalued to consider the types of supporting documentation
listed in the beginning of this section, as that information is
important for us to consider in our process for reviewing nominations
of potentially misvalued codes.
D. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
a. Changes to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a regulatory process for adding services to or deleting
services from the Medicare Telehealth Services List in accordance with
section 1834(m)(4)(F)(ii) of the Act (Sec. 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
Telehealth Services List to one of the following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current Medicare Telehealth Services List. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits. Some examples of other clinical benefits that we consider
include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
In the CY 2021 PFS final rule (85 FR 84507), we created a third
category of criteria for adding services to the Medicare Telehealth
Services List on a temporary basis following the end of the PHE for the
COVID-19 pandemic: Category 3. This new category describes services
that were added to the Medicare Telehealth Services List during the PHE
for which there is likely to be clinical benefit when furnished via
telehealth, but there is not yet sufficient evidence available to
consider the services for permanent addition under the Category 1 or
Category 2 criteria. Services added on a temporary, Category 3 basis
will ultimately need to meet the criteria under Category 1 or 2 in
order to be permanently added to the Medicare Telehealth Services List.
To add specific services on a Category 3 basis, we conducted a clinical
assessment to identify those services for which we could foresee a
reasonable potential likelihood of clinical benefit when furnished via
telehealth. We considered the following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns for patient safety if the service is furnished as a
telehealth service.
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns about whether the provision of the service via
telehealth is likely to jeopardize quality of care.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio-video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare Telehealth Services List using
the Category 3 criterion described above. We assessed codes that were
temporarily available on the list for the duration of the PHE to
determine their appropriateness for inclusion on the Medicare
Telehealth Services List on a Category 3 basis. We have reassessed the
services that are temporarily available via telehealth for the PHE,
based on both information provided by interested parties and our own
internal review. We have assessed whether or not these services can,
outside of the circumstances of the PHE, be furnished using the full
scope of service elements via two-way, audio-video communication
technology, without jeopardizing patient safety or quality of care, and
we now believe that there are additional services that would be
appropriate for addition to the Medicare Telehealth Services List on a
Category 3 basis that we did not identify in the CY 2021 rulemaking. In
the proposed rule, we proposed to add these additional services to the
Medicare Telehealth Services List on a Category 3 basis, as further
discussed below.
[[Page 69446]]
The Medicare Telehealth Services List, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Beginning in CY 2019, we stated that for CY 2019 and onward, we
intend to accept requests through February 10, consistent with the
deadline for our receipt of code valuation recommendations from the RUC
(83 FR 59491). For CY 2023, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2022. Each request to add a service to the Medicare
Telehealth Services List must have included any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the Medicare Telehealth Services List,
requesters are advised that any information submitted as part of a
request is subject to public disclosure for this purpose. For more
information on submitting a request in the future to add services to
the Medicare Telehealth Services List, including where to submit these
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2023
Under our current policy, we add services to the Medicare
Telehealth Services List on a Category 1 basis when we determine that
they are similar to services on the existing Medicare Telehealth
Services List for the roles of, and interactions among, the
beneficiary, physician (or other practitioner) at the distant site and,
if necessary, the telepresenter. As we stated in the CY 2012 PFS final
rule with comment period (76 FR 73098), we believe that the Category 1
criterion not only streamlines our review process for publicly
requested services that fall into this category, but also expedites our
ability to identify codes for the Medicare Telehealth Services List
that resemble those services already on the Medicare Telehealth
Services List. We add services on a Category 2 basis when the service
does not fall within Category 1, and based upon our assessment of
whether the services are accurately described by the corresponding code
when delivered via telehealth and whether the use of a
telecommunications system to deliver the service produces demonstrated
clinical benefit to the patient. We add services on a temporary
Category 3 basis when the services were temporarily included on the
Medicare Telehealth Services List during the PHE, and we find that
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition under the Category 1 or Category 2
criteria.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2023. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare Telehealth Services List. We also assessed the
appropriateness of adding these services to the Medicare Telehealth
Services List on a Category 3 basis instead.
We did not propose changes to the length of time the services that
we temporarily included on a Category 3 basis will remain on the
Medicare Telehealth Services List; the services we temporarily included
on the Medicare Telehealth Services List on a Category 3 basis will
continue to be included through the end of CY 2023. In the CY 2023 PFS
proposed rule, we noted that in the event that the PHE extends well
into CY 2023, we may consider revising this policy.
We proposed to add some services to the Medicare Telehealth
Services List on a Category 3 basis through the end of 2023, some of
which we had not previously added to the Medicare Telehealth List
during the PHE, but have been added on a subregulatory basis as
provided in Sec. 410.78(f) of our regulations. For some of these
services, we received information from interested parties suggesting
potential clinical benefit. For others, we continue to believe there is
sufficient evidence of potential clinical benefit to warrant allowing
additional time for interested parties to gather data to support their
possible inclusion on the Medicare Telehealth Services List on a
Category 1 or 2 basis. The Medicare Telehealth Services List requests
for CY 2023 are listed in Table 11.
Additionally, the Consolidated Appropriations Act, 2022 (CAA, 2022)
(Pub. L. 117-103, March 15, 2022) amended section 1834(m) of the Act to
extend a number of flexibilities that are in place during the PHE for
COVID-19 for 151 days after the end of the PHE. To align the
availability of these services with those flexibilities extended under
the Act, we proposed to continue to allow certain telehealth services
that would otherwise not be available via telehealth after the
expiration of the PHE to remain on the Medicare Telehealth Services
List for 151 days after the expiration of the PHE.
BILLING CODE 4150-28-P
[[Page 69447]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.013
[[Page 69448]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.014
[[Page 69449]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.015
BILLING CODE 4150-28-C
We remind interested parties that the criterion for adding services
to the Medicare Telehealth Services List under Category 1 is that the
requested services are similar to professional consultations, office
visits, and/or office psychiatry services that are currently on the
Medicare Telehealth Services List, and that the criterion for adding
services under Category 2 is that there is evidence of clinical benefit
if provided as telehealth. As explained below, we find that none of the
requested services listed in Table 11 met the Category 1 or 2 criteria.
We received a request to permanently add CPT code S9443 (Lactation
classes, non-physician provider, per session) to the Medicare
Telehealth Services List. This service has a status code of ``I,''
which means that it is not valid for Medicare billing purposes. We
understand that this is a temporary code established by a private payor
for private payor use, and thus, it is not valid for nor payable by
Medicare. As such, this code is not separately billable under the PFS.
We generally do not add services to the Medicare Telehealth Services
List unless they are separately billable under the PFS. Outside of the
circumstances of the PHE, the Medicare Telehealth Services List only
includes services that are covered if they are furnished without the
use of telecommunication technology in-person. Because CPT code S9443
is not billable under the PFS when furnished in-person, we do not
believe it would be appropriate to allow the service to be billed
separately when furnished as a Medicare telehealth service. As noted in
the CY 2018 PFS final rule (82 FR 53011), if a service does not
describe a service typically furnished in-person, it would not be
considered a telehealth service under the applicable provisions of the
statute. We did not propose to add CPT code S9443 to the Medicare
Telehealth Services List.
Comment: A commenter requested that this code (CPT code S9443) be
added on a Category 3 basis, citing financial pressures and staff
shortages, which are affecting labor and delivery units.
Response: We thank the commenter for this comment, but as noted in
the proposed rule, this code is not separately billable under the PFS
when furnished in-person, so we do not believe that it should be
considered a telehealth service within the meaning of the statute. We
continue to believe it would be inappropriate to allow CPT code S9443
to be billed separately when furnished as a Medicare telehealth
service, and we are finalizing our proposal not to add CPT code S9443
to the Medicare Telehealth Services List.
(1) Therapy Services
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations: CPT codes
97161-97164; Therapy Personal Care services: CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services: CPT codes
97750, 97755, and 97763, to the Medicare Telehealth Services List on a
Category 1 basis.
In the CY 2022 PFS final rule (86 FR 65051), we determined that
these services did not meet the Category 1 criteria for addition to the
Medicare Telehealth Services List because they involve direct
observation and/or physical contact between the practitioner and the
patient and, in many instances, are therapeutic in
[[Page 69450]]
nature, and that they did not meet Category 2 criteria, because we
thought that the request did not provide sufficient detail to determine
whether all of the necessary elements of the service could be furnished
remotely. We continue to believe this is the case. We still do not have
sufficient information to determine whether these services meet the
Category 2 criteria. However, we noted that some of these codes,
including codes 97110, 97112, 97116, 97150, 97530, 97161-97164, 97535,
97542, 97750, and 97755 have been added to the list on a temporary
basis for the duration of the PHE.
In assessing the evidence that was supplied by interested parties
in support of adding these services to the Medicare Telehealth Services
List on a Category 2 basis, we concluded that there was not sufficient
information to determine whether all of the necessary elements of these
services could be furnished remotely. Information regarding safety,
appropriateness, and that indicates that all elements of a given CPT
code can be furnished via telehealth is still needed to assess whether
these services meet the Category 2 criteria. However, we also believe
that the therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE (including CPT codes
97150, 97530, and 97542), but are not currently included on a Category
3 basis, may continue to be furnished safely via two-way, audio-video
communication technology outside of the circumstances of the PHE.
Therefore, we proposed that CPT codes 97150, 97530, and 97542 (the
set of therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE) be added to the
Medicare Telehealth Services List through the end of CY 2023 on a
temporary, Category 3 basis, to allow time to gather additional data
that could support their possible inclusion on the list on a permanent
basis. CPT codes 97110, 97112, 97116, 97161-97168, 97535, 97750, and
97755 will continue to be available on the Medicare Telehealth Services
List on a Category 3 basis. We anticipate that keeping these services
on the Medicare Telehealth Services List on a Category 3 basis, as
proposed, through the end of CY 2023 would preserve access to care and
promote health equity, and based on information provided by interested
parties and internal review, we believe that they may safely be
furnished as telehealth outside of the circumstances of the PHE through
the end of CY 2023. However, we remind readers that the practitioners
who primarily furnish these services, physical therapists, are not,
outside the circumstances of the PHE (and the 151-day period following
the expiration of the PHE), authorized to furnish Medicare telehealth
services. We noted that, if the PHE and the 151-day period following
the expiration of the PHE both end in CY 2023, the pre-PHE rules will
take effect, and these services could no longer be furnished by
therapists as Medicare telehealth services.
Certain other requested therapy services, namely CPT codes 97537,
97763, 90901, and 98960-98962 were not on the Medicare Telehealth
Services List prior to June 16, 2022; however, we added these services
to the Medicare Telehealth Services List on a temporary basis during
the PHE, in accordance with Sec. 410.78(f). As explained below in
section II.D.1.d. of this final rule, services included on the Medicare
Telehealth Services List on a temporary basis during the PHE that have
not been added to the list on a Category 3 basis will remain on the
list for 151 days following the end of the PHE. Furthermore, we
proposed to add CPT codes 97537, 97763, 90901, and 98960-98962 to the
Medicare Telehealth Services List on a Category 3 basis through the end
of CY 2023. Our clinical analyses of these services indicate that they
can be furnished in full using two-way, audio and video technology
during the circumstances of the PHE, and information provided by
requestors indicates that there may be clinical benefit; however, there
is not yet sufficient evidence available to consider the services for
permanent addition to the Medicare Telehealth Services List under the
Category 1 or Category 2 criteria. Including these services on the
Medicare Telehealth Services List during the PHE and through CY 2023
will allow additional time for the development of evidence for CMS to
consider when evaluating these services for potential permanent
addition to the Medicare Telehealth Services List on a Category 1 or 2
basis. We continue to encourage commenters to supply additional
information in support of adding these services to the Medicare
Telehealth Services List on a permanent basis, including information
regarding the safety and appropriateness of furnishing these services
via telehealth.
Comment: Several commenters supported our addition of the listed
therapy services to the Medicare Telehealth Services List on a Category
3 basis. However, commenters stated that many of these codes should be
added permanently; commenters specifically stated that therapy
services, including CPT codes 97110, 97112, 97116, 97150, 97161-97164,
97530, 97535, 97537, 97542, 97750, 97755, 97763, 90901, 98960, 98961,
and 98962 should be added permanently, stating that these codes have
been used successfully to provide telehealth services throughout the
PHE and have shown that the same quality of care can be given with
equal or higher levels of patient satisfaction as in-person visits.
According to these commenters, the PHE has given ample data to support
that, when used appropriately, telehealth can have a positive effect on
outcomes for patients who are restricted from a full course of in-
person therapy visits, which they claim is at a lower cost of care, and
the inclusion of these therapy service codes on the Medicare Telehealth
Services List on a Category 1 or Category 2 basis would preserve access
to these services beyond the temporary extension and ease
administrative burden should Congress act in the future to make
rehabilitation services delivered via telehealth permanent.
Response: We note that all of the above-mentioned therapy services
are either currently on the Medicare Telehealth Services List on a
Category 3 basis, or we have proposed to add them on a Category 3 basis
for CY 2023, to continue to gather data with regard to likely clinical
benefit when furnished via telehealth outside of the circumstances of
the PHE. We continue to believe that the process as discussed in the CY
2021 PFS final rule (85 FR 84506 through 84509), whereby we created the
Category 3 basis for adding to or deleting services from the Medicare
Telehealth Services List is the appropriate means of potentially adding
services permanently for those services that were temporarily added
under the circumstances of the PHE, as this process allows for the
collection and evaluation of data that could potentially support
permanent inclusion following the 151-day period after the end of the
PHE. We believe our proposal, consistent with the amendments made by
provisions of the CAA, 2022, to extend the period that these services
will be available on the Medicare Telehealth Services List temporarily
for the PHE by 151 days following the end of the PHE will further
enhance the opportunity for the collection of information on the
experiences of clinicians who are furnishing telehealth services during
the PHE for COVID-19. This will also help us to determine which
services may ultimately be eligible for permanent addition under
Category 1 or Category 2 criteria, and we encourage interested parties
to use this
[[Page 69451]]
extended time period to gather data on use of services, that is more
than statements of support and more than subjective attestations of
clinical benefit, to support their potential addition in future
rulemaking.
Comment: Commenters requested clarification on whether CPT codes
for Occupational Therapy (97165, 97166, 97167, and 97168) and Speech
Therapy (92522 and 92523) were included in the list of Category 3 codes
for CY 2023, and should be added on a Category 3 basis.
Response: We clarify that these codes (CPT codes 97165-97168 and
92521-92524) are currently included on the Medicare Telehealth Services
List available on a Category 3 basis.
After consideration of public comments, we are finalizing our
proposed addition of CPT codes 90901, 97150, 97530, 97537, 97542,
97763, and 98960-98962 to the Medicare Telehealth Services List on a
Category 3 basis.
(2) Telephone E/M Services
We have also received requests to temporarily add Telephone E/M
visit codes, CPT codes 99441, 99442, and 99443 to the Medicare
Telehealth Services List on a Category 3 basis. In the March 31, 2020
interim final rule with comment period (IFC), we established separate
payment for audio-only telephone E/M services (85 FR 19264 through
19266) for the duration of the PHE for the COVID-19 pandemic. Although
these services were previously considered non-covered under the PFS, in
the context of the PHE for COVID-19 and with the goal of reducing
exposure risks associated with COVID-19 (especially in situations when
two-way, audio and video technology is not available to furnish a
Medicare telehealth service), we believed there were circumstances
where prolonged, audio-only communication between the practitioner and
the patient could be clinically appropriate, yet not fully replace a
face-to-face visit. In the May 8, 2020 COVID-19 IFC, we noted that
interested parties had informed us that use of audio-only services was
more prevalent than we had previously considered, especially because
many beneficiaries were not using video-enabled communication
technology from their homes. In other words, there were many cases
where practitioners who would ordinarily furnish audio-video telehealth
or in-person visits to evaluate and manage patients' medical concerns
were instead using audio-only interactions to manage more complex care
(85 FR 27589 through 27590). While we had previously acknowledged the
likelihood that, under the circumstances of the PHE for COVID-19, more
time would be spent interacting with the patient via audio-only
technology, we stated that the intensity of furnishing an audio-only
visit to a beneficiary during the unique circumstances of the PHE for
COVID-19 was not accurately captured by the valuation of these services
that we established in the March 31, 2020 IFC (85 FR 27590). This will
be particularly true to the extent that these audio-only services are
serving as a substitute for office/outpatient (O/O) Medicare telehealth
visits for beneficiaries not using video-enabled telecommunications
technology, which is contrary to the situation we anticipated when
establishing separate payment for them in the March 31, 2020 IFC. In
the May 8, 2020 COVID-19 IFC, we stated that, given our understanding
that these audio-only services were being furnished primarily as a
replacement for care that would otherwise be reported as an in-person
or telehealth visit using the O/O E/M codes, we established new RVUs
for the telephone E/M services based on crosswalks to the most
analogous O/O E/M codes, based on the time requirements for the
telephone codes and the times assumed for valuation for purposes of the
O/O E/M codes. Specifically, we crosswalked the levels 2-4 O/O E/Ms for
established patients, as described by CPT codes 99212, 99213, and
99214, to CPT codes 99441, 99442, and 99443, respectively.
Additionally, we stated that, given our understanding that these audio-
only services were being furnished as substitutes for O/O E/M services,
we recognized that they should be considered as telehealth services,
and added them to the Medicare Telehealth Services List for the
duration of the PHE for COVID-19 (85 FR 27590).
In the CY 2022 PFS final rule (86 FR 65055), in response to
requests that these codes be added to the Medicare Telehealth Services
List on a Category 3 basis, we stated that we were finalizing a change
to the definition of ``telecommunications system'' to allow telehealth
services for the diagnosis, evaluation, and treatment of mental health
conditions to be furnished through audio-only technology in certain
circumstances after the end of the PHE. For example, the O/O E/M codes
are on the Medicare Telehealth Services List permanently and when used
to describe care for mental health conditions, will be reportable when
furnished via audio-only technology to patients in their homes. Since
audio-only telecommunications technology can be used to furnish mental
health telehealth services to patients in their homes, the addition of
these codes to the Medicare Telehealth Services List is unnecessary for
mental health telehealth services. For telehealth services other than
mental health care, we stated that we believe that two-way, audio-video
communications technology is the appropriate standard that will apply
for telehealth services after the PHE ends. Further, we noted that
section 1834(m)(2)(A) of the Act requires that payment to a distant
site physician or practitioner that furnishes Medicare telehealth
services to an eligible telehealth individual be equal to the amount
that would have been paid under Medicare if such physician or
practitioner had furnished the service without a telecommunications
system. We believe that the statute requires that telehealth services
be so analogous to in-person care such that the telehealth service is
essentially a substitute for a face-to-face encounter. However, these
audio-only telephone E/M services are inherently non-face-to-face
services, since they are furnished exclusively through remote, audio-
only communications. Outside the circumstances of the PHE, the
telephone E/M services would not be analogous to in-person care; nor
would they be a substitute for a face-to-face encounter. Therefore, we
do not believe it will be appropriate for these codes to remain on the
Medicare Telehealth Services List after the end of the PHE and the 151-
day post-PHE extension period. Accordingly, we did not propose to keep
these telephone E/M services on the Medicare Telehealth Services List
after that period on a Category 3 basis, because the codes describe
services that can only be furnished using audio-only telecommunications
technology, and outside of the circumstances of the PHE, they do not
describe services that are a substitute for an in-person visit. While
we acknowledge that audio-only technology can be used to furnish mental
health telehealth services to patients in their homes under certain
circumstances after the PHE ends, two-way, audio-video communications
technology continues to be the appropriate standard that will apply for
Medicare telehealth services after the PHE and the 151-day extension
period. As we noted in the CY 2021 PFS final rule (85 FR 84535), we
will assign these Telephone E/M visit codes (CPT codes 99441, 99442,
and 99443) a ``bundled'' status after the end of the PHE and the 151-
day extension period, and we will post the RUC-recommended RVUs for
[[Page 69452]]
these codes in accordance with our usual practice.
We received public comments on Telephone E/M Services. The
following is a summary of the comments we received and our responses.
Comment: Many commenters urged us to continue to make payment for
Telephone E/M visit codes following 151 days after the PHE. Some
commenters stated that payment for these services should be made
permanent while others request that they be added to the Medicare
Telehealth Services List on a Category 3 basis. Commenters stated that
experience during the PHE indicated that telehealth can provide a
viable alternative to office visits. Commenters stated that, although
patient-provider communication using both audio and visual modes is
considered optimal for telehealth delivery, many patients are unable to
use the video technology required due to lack of broadband or cellular
data, technology that does not support video, or difficulty in using
video technology. Commenters cited access concerns, particularly for
patients who live in rural areas or who lack of broadband access, as
well as disparities in access to technology and in digital literacy.
A commenter noted that, in the CY 2023 PFS proposed rule, CMS
further stated that telephone E/M services are neither analogous to an
in-person E/M visit nor can the telephone E/M substitute for an in-
person E/M visit. However, as noted above, in the second IFC, CMS did
believe telephone E/Ms were serving as a substitute for in-person E/M
visits, and because of that, began to reimburse them the same rate as
in-person E/M visits. Commenters noted that this would indicate they
are analogous to an in-person service and would fit the criteria to be
on the Medicare Telehealth Services List permanently.
Response: We reiterate that we believe these audio-only telephone
E/M services are inherently non-face-to-face services, since they are
furnished exclusively through remote, audio-only communications. We
continue to believe that, outside the circumstances of the PHE, these
services will no longer serve as a substitute for in-person care that
is ordinarily furnished in a face-to-face encounter. Section 1834(m)(1)
of the Act requires that we make payment for telehealth services
``notwithstanding that the individual physician or practitioner
providing the telehealth service is not at the same location as the
beneficiary.'' Section 1834(m)(2)(A) of the Act requires that we make
payment to a physician or practitioner located at a distant site for a
telehealth service at an amount equal to the amount that the physician
or practitioner would have been paid if the service had instead been
furnished without the use of a telecommunications system. Taken
together, we believe that the statute requires that Medicare telehealth
services be analogous to in-person care such that the telehealth
service is essentially a substitute for a face-to-face encounter. We
recognize that we added the telephone E/M services to the Medicare
Telehealth Services List on a temporary basis during the PHE to address
the associated extraordinary public health and safety, and healthcare
access issues. However, outside of the circumstances of the PHE, we
continue to believe that our longstanding regulatory interpretation of
``telecommunications system'' generally precludes the use of audio-only
technology for purposes of Medicare telehealth services, with the
exception under certain circumstances of telehealth services to
diagnose, evaluate, or treat a mental health disorder (including
treatment of a diagnosed SUD or co-occurring mental health disorder).
That rule and the exception are specified in our regulation at Sec.
410.78(a)(3). At the conclusion of the PHE and the 151-day extension
period provided by the CAA, 2022, the only Medicare telehealth services
that will be permitted to be furnished using audio-only technology will
be the mental health telehealth services. When a practitioner furnishes
such an E/M service using audio-only technology, they would bill for
the same service they would bill if the service had been furnished in
person. As such, there is not a need to add the telephone-only E/M
codes to the Medicare Telehealth Services List for this purpose.
Comment: A commenter stated that, if CMS removes the telephone E/M
CPT codes 99441-99443 from the Medicare Telehealth Services List on the
152nd day after the PHE ends, CMS should then create and establish
particular values for a third and higher level of virtual check-in
service that would be similar to the telephone E/M services that have
been available during the PHE. The commenter is requesting that this
third virtual check-in code would crosswalk to CPT code 99443, and
should assign RVUs to HCPCS codes G2012 (Brief communication
technology-based service, e.g. virtual check-in, by a physician or
other qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related e/m service provided within the previous 7
days nor leading to an e/m service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion), G2252 (Brief communication technology-based service, e.g.
virtual check-in, by a physician or other qualified health care
professional who can report evaluation and management services,
provided to an established patient, not originating from a related e/m
service provided within the previous 7 days nor leading to an e/m
service or procedure within the next 24 hours or soonest available
appointment; 11-20 minutes of medical discussion), and a third
potential check-in code with crosswalks to CPT codes 99441-99443,
respectively.
Response: We appreciate the comment and may consider potential
coding revisions for future rulemaking. However, we believe that, in
light of the fact that the virtual check-in codes are intended for
practitioners to have a non-face-to-face discussion with a patient to
determine the need for care, the necessity for a longer virtual check-
in (for example, 21-30 minutes) is not clear. Moreover, if a patient
requires evaluation and management (E/M) services that are sufficiently
complicated to last longer than the 11-20 minutes considered in HCPCS
code G2252, then there are many other E/M visit codes that are already
available as Medicare telehealth.
After consideration of public comments, we are finalizing our
proposal not to add these CPT codes 99441-99443 to the Medicare
Telehealth Services List on a Category 3 basis; rather, we will retain
CPT codes 99441-99443 on the Medicare Telehealth Services List through
expiration of the 151-day period following the end of the PHE, at which
point they will revert to bundled status.
(3) GI Tract Imaging and Continuous Glucose Monitoring
We received requests to add CPT codes describing GI Tract Imaging,
CPT code 91110 (Gastrointestinal tract imaging, intraluminal (e.g.,
capsule endoscopy), esophagus through ileum, with interpretation and
report) and Ambulatory Continuous Glucose Monitoring, CPT code 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; analysis,
interpretation and report), to the Medicare Telehealth Services List on
a Category 3 basis. We believe these codes may describe services that
are inherently non-face-to-face services, (the patient need not be
[[Page 69453]]
present in order for the service to be furnished in its entirety), and
therefore, they do not describe services that are a substitute for an
in-person visit. As stated earlier, we believe that the statute
requires that telehealth services be so analogous to in-person care
such that the telehealth service is essentially a substitute for a
face-to-face encounter. For this and other reasons, we did not propose
to add these services to the Medicare Telehealth Services List on a
Category 3 basis; we do not believe these CPT codes describe services
that are a substitute for an in-person visit, and we believe that
services that are not inherently face-to-face services are not services
that can be furnished as Medicare telehealth services. Even so, we are
interested in information that would help us to understand whether
these services would meet the criteria for inclusion on the Medicare
Telehealth Services List either for the PHE, as Category 3 services, or
permanently on a Category 1 or 2 basis, given our questions as to
whether they are inherently non-face-to-face services, and therefore,
may not fit within the scope of services that could be furnished as
Medicare telehealth services. Therefore, we also solicited comment on
whether these services would involve an in-person service when
furnished without the use of a telecommunications system.
We received public comments on GI Tract Imaging and Continuous
Glucose Monitoring. The following is a summary of the comments we
received and our responses.
Comment: A commenter agreed that CPT code 91110 describes a service
that is inherently a non-face-to-face service, as the patient is not
present in order for the service to be furnished in its entirety. The
commenter described the services as involving swallowing a capsule
camera that captures images of the gastrointestinal tract, which are
recorded on the capsule and subsequently reviewed by the clinician
using special computer software. The commenter stated that the
ingestion of the capsule is the only component of this service that
requires direct observation by a health care provider. The commenter
noted that less than 10 percent of the service time/work associated
with CPT code 91110 involves any direct interaction with the patient,
and the small amount of patient interaction can be done safely and
effectively via a telehealth visit with video, per the FDA clearance.
According to one commenter, since the capsule service should only
be offered to an established patient, an in-person interaction to
administer the capsule is unnecessary and the patient can safely do so
in the home setting.
Response: We appreciate this background information from the
commenters. Given that this service describes collection,
interpretation, and reporting, we believe this code describes services
that are not inherently non-face-to-face, and therefore, they do not
describe a service that is a substitute for an in-person visit.
Additionally, the face-to-face portion of the service would require the
patient to be physically present.
Comment: Some commenters agreed with CMS' assessment that
Ambulatory Continuous Glucose Monitoring, CPT code 95251, is an
inherently non-face-to-face service, and therefore, does not describe a
service that is a substitute for an in-person visit. CPT code 95251
does not involve an in-person visit when furnished without the use of a
telecommunications system.
One commenter opposed our proposal not to add CPT code 95251 to the
Medicare Telehealth Services List on a Category 3 basis, citing the
importance of this service in treating gestational diabetes, saying CMS
should add CPT code 95251 to the list on a Category 3 basis when it is
billed with CPT codes 99213 (Established patient office or other
outpatient visit, 20-29 minutes) or 99214 (Established patient office
or other outpatient visit, 30-39 minutes) and the appropriate modifier.
Another commenter cited 2020 claims data that shows CPT code 95251 is
billed 8.2 percent and 62.6 percent of the time with CPT codes 99213
and 99214, respectively, demonstrating that this service is typically
performed face-to-face.
Response: We appreciate the comments. We continue to believe, and
commenters have confirmed, that CPT code 95251 is not a substitute for
an in-person visit, as this code describes physician analysis,
interpretation, and reporting, which does not inherently describe a
face-to-face encounter. Accordingly, this code does not describe a
service that, when conducted via telehealth, is a substitute for a
face-to-face service. As noted in the CY 2018 PFS final rule (82 FR
53011), if a service does not describe a service typically furnished
in-person, it would not be considered a telehealth service under the
applicable provisions of the statute.
After consideration of public comments, we are finalizing our
proposal not to add CPT code 91110 or CPT code 95251 to the Medicare
Telehealth Services List on a Category 3 basis.
(4) Neurostimulator Pulse Generator/Transmitter
We received requests to add codes describing the electronic
analysis of an implanted neurostimulator pulse generator/transmitter to
the Medicare Telehealth Services List. These included a request to add
CPT codes 95976 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with simple
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) and 95977
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with complex
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) permanently
on a Category 1 basis, as well as a request to add CPT codes 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain,
cranial nerve, spinal cord, peripheral nerve, or sacral nerve,
neurostimulator pulse generator/transmitter, without programming),
95983 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, first 15
[[Page 69454]]
minutes face-to-face time with physician or other qualified health care
professional), and 95984 (Electronic analysis of implanted
neurostimulator pulse generator/transmitter (e.g., contact group[s],
interleaving, amplitude, pulse width, frequency [Hz], on/off cycling,
burst, magnet mode, dose lockout, patient selectable parameters,
responsive neurostimulation, detection algorithms, closed loop
parameters, and passive parameters) by physician or other qualified
health care professional; with brain neurostimulator pulse generator/
transmitter programming, each additional 15 minutes face-to-face time
with physician or other qualified health care professional (List
separately in addition to code for primary procedure)) to the Medicare
Telehealth Services List on a temporary Category 3 basis.
The request to add CPT codes 95976 and 95977, which are codes that
describe analysis of cranial nerve neurostimulation, indicated that the
ability to fully furnish this service using two-way, audio-video
communication technology was forthcoming, but is currently unavailable.
Therefore, we did not propose to add CPT codes 95976 and 95977 to the
Medicare Telehealth Services List, because the full scope of service
elements described by these codes cannot currently be furnished via
two-way, audio-video communication technology. However, we will
consider additional evidence regarding the ability to furnish these
services as telehealth services, such as information indicating that
current technology has evolved, as it becomes available for future
rulemaking. We also did not propose to add them on a Category 1 basis
because they do not describe services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List.
With regard to CPT codes 95970, 95983, and 95984, which describe
general brain nerve neurostimulation, we have some concerns about
whether the full scope of service elements could be furnished via two-
way, audio-video communication technology, particularly since it is
unclear whether the connection between the implanted device and the
analysis/calibration equipment can be done remotely. Additionally, we
are concerned about the immediate safety of the patient if the
calibration of the neurostimulator were done incorrectly or if some
other problem occurred. However, we did include these services on the
Medicare Telehealth Services List on a temporary basis during the PHE,
and Medicare claims data suggest that these services are being provided
via telehealth. Based on this information, we believe there is some
possible clinical benefit for these services when furnished via
telehealth; however, there is not yet sufficient evidence available to
consider the services for permanent addition to the Medicare Telehealth
Services List under the Category 1 or Category 2 criteria. With that
said, CPT codes 95970, 95983, and 95984 do meet the criteria for
temporary inclusion on the Medicare Telehealth Services List on a
Category 3 basis. Therefore, we proposed to add CPT codes 95970, 95983,
and 95984 to the Medicare Telehealth Services List on a Category 3
basis, while we solicited comment on our concerns regarding patient
safety and whether these services are appropriate for inclusion on the
Medicare Telehealth Services List outside the circumstances of the PHE.
Comment: Commenters agreed with CMS that the full scope of service
elements described by CPT codes 95976 and 95977 cannot currently be
furnished via two-way, audio-video communication technology, and they
state that the agency should reconsider these services for possible
addition to the Medicare Telehealth Services List as evidence develops
regarding the ability to furnish these services as telehealth services.
Response: We appreciate commenters' support for this proposal and
are finalizing our proposal to not add these services to the Medicare
Telehealth Services List.
Comment: Commenters supported our proposal to add CPT codes 95970,
95983, and 95984 to the Medicare Telehealth Services List on a Category
3 basis. Some commenters expressed disappointment that we did not
propose to add them to the Medicate Telehealth Services List
permanently. In response to our comment solicitation regarding patient
safety concerns, a commenter noted that the technology includes safety
features, including a prominent network status indicator that appears
on both the clinician's programmer, as well as the patient's device,
and the ``Protected Recovery Program'' (PRP) feature that ensures the
patient is returned to a known state if a remote session is
interrupted. According to one commenter, systems have been successfully
in use for over a year and a half that allow for a stable, secure 2-way
telehealth connection for brain stimulator pulse generator programming.
Commenters stated that these systems route through a secure HIPAA-
compliant server and allow the managing physician qualified health care
professional (QHP) to remotely control all essential functions of the
patient device while providing real time audio and video to allow for
patient assessment and feedback. The commenter noted that CMS' concerns
regarding patient safety if the programming is incorrect or if another
problem occurred have been addressed in the development and deployment
of existing remote brain neurostimulator programming systems. The
commenter stated that these systems ensure that the patient controller
has a ``safe'' program (set of stimulation parameters). In the event of
an interruption in the remote connection, they noted that the device
automatically reverts to this ``safe'' program, so that the patient is
not left with a potentially problematic set of programming parameters.
The commenter also noted that all elements can be fully and
effectively performed by a remotely located clinician using two-way,
audio/video telecommunication technology including direct programming
of implantable neurostimulator devices, and these services are critical
to the successful therapy regimens and health outcomes of people with
Parkinson's disease.
Response: We continue to believe that these services are most
appropriately added to the Medicare Telehealth Services on a Category 3
basis. Adding them on a Category 3 basis will allow the continued
collection of information through the experiences of clinicians who are
furnishing these services via telehealth during the PHE for COVID-19,
and help us to determine whether these services may ultimately be
eligible for addition to the Medicare Telehealth Services List on a
Category 1 or Category 2 basis. We encourage interested parties to use
this extended time period to gather data on these services to support
their potential addition to the Medicare Telehealth Services List on a
Category 1 or Category 2 basis in the future.
After consideration of public comments, we are finalizing our
proposals not to add CPT codes 95976 and 95977 to the Medicare
Telehealth Services List, and to add CPT codes 95970, 95983, and 95984
to the Medicare Telehealth Services List on a Category 3 basis.
(5) Emotional/Behavior Assessment Services and Psychological or
Neuropsychological Testing and Evaluation Services
We received requests to add a number of emotional/behavior
assessment services and psychological, or neuropsychological testing
and evaluation services, described by CPT codes 97151 (Behavior
identification assessment, administered by a
[[Page 69455]]
physician or other qualified health care professional, each 15 minutes
of the physician's or other qualified health care professional's time
face-to-face with patient and/or guardian(s)/caregiver(s) administering
assessments and discussing findings and recommendations, and non-face-
to-face analyzing past data, scoring/interpreting the assessment, and
preparing the report/treatment plan), 97152 (Behavior identification-
supporting assessment, administered by one technician under the
direction of a physician or other qualified health care professional,
face-to-face with the patient, each 15 minutes), 97153 (Adaptive
behavior treatment by protocol, administered by technician under the
direction of a physician or other qualified health care professional,
face-to-face with one patient, each 15 minutes), 97154 (Group adaptive
behavior treatment by protocol, administered by technician under the
direction of a physician or other qualified health care professional,
face-to-face with two or more patients, each 15 minutes), 97155
(Adaptive behavior treatment with protocol modification, administered
by physician or other qualified health care professional, which may
include simultaneous direction of technician, face-to-face with one
patient, each 15 minutes), 97156 (Family adaptive behavior treatment
guidance, administered by physician or other qualified health care
professional (with or without the patient present), face-to-face with
guardian(s)/caregiver(s), each 15 minutes), 97157 (Multiple-family
group adaptive behavior treatment guidance, administered by physician
or other qualified health care professional (without the patient
present), face-to-face with multiple sets of guardians/caregivers, each
15 minutes), 97158 (Group adaptive behavior treatment with protocol
modification, administered by physician or other qualified health care
professional, face-to-face with multiple patients, each 15 minutes),
0362T (Behavior identification supporting assessment, each 15 minutes
of technicians' time face-to-face with a patient, requiring the
following components: administration by the physician or other
qualified health care professional who is on site; with the assistance
of two or more technicians; for a patient who exhibits destructive
behavior; completion in an environment that is customized to the
patient's behavior.), and 0373T (Adaptive behavior treatment with
protocol modification, each 15 minutes of technicians' time face-to-
face with a patient, requiring the following components: administration
by the physician or other qualified health care professional who is on
site; with the assistance of two or more technicians; for a patient who
exhibits destructive behavior; completion in an environment that is
customized to the patient's behavior.) to the Medicare Telehealth
Services List permanently on a Category 2 basis. These services are
currently on the Medicare Telehealth Services List temporarily for the
duration of the PHE. We believe that, for these services, there is
likely to be clinical benefit when furnished via telehealth, and
therefore, they meet the criteria for temporary inclusion on a Category
3 basis. We did not identify these services during our initial
assessment of services that should be temporarily available on the
Medicare Telehealth Services List on a Category 3 basis in CY 2021
rulemaking; however, we proposed to include these services on the
Medicare Telehealth Services List on a Category 3 basis, in light of
information we received from the requestors describing the potential
clinical benefit of these services when furnished via telehealth.
However, we do have concerns regarding whether, outside the
circumstances of the PHE, the full scope of service elements can occur
in a manner that does not jeopardize quality of care, whether this
patient population could be fully assessed via interactive audio-video
technology, and whether these services could be conducted in a way that
maintains the safety of the beneficiary. This patient population often
includes patients with moderate to severe challenges in oral
communication, and they may require close observation of their
movements within all of their environmental cues, which include, for
instance, smell, sound, and colors around the room. We are concerned
that two-way, audio and video communications technology would not fully
capture these behavioral nuances. We believe more time may be necessary
to develop evidence that could support the decision to add these
services to the Medicare Telehealth Services List permanently on a
Category 1 or Category 2 basis. We solicited comment on our patient
safety concerns.
We received public comments on emotional/behavior assessment and
psychological or neuropsychological testing and evaluation services.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported the addition of these services
on a Category 3 basis. Some commenters suggested that the services
should be added permanently, rather than temporarily on a Category 3
basis.
One commenter urged us to permanently add CPT codes 97151, 97152,
97153, 97154, 97155, and 97156, but did not find sufficient evidence
supporting safe, effective telehealth delivery of the services
represented by codes 97157, 97158, 0362T, or 0373T; however, the
commenter supported our proposal to add the latter four codes on a
Category 3 basis.
A few commenters responded to our concerns regarding patient
safety, quality of care, and whether the full scope of service elements
can be met via two-way audio-video communication technology. In
response to our questions about regarding whether this patient
population can be assessed fully and safely via interactive audio-video
technology and our concerns that patients with moderate to severe
communication difficulties often require close observation of their
responses to cues in their environments (for example, odors, sounds,
colors) that could not be accomplished remotely via technology, a
commenter acknowledged our concerns, but noted that the services
represented by this code set are not specific to any patient
population; rather, they noted that they are for any patient for whom
they may be medically necessary. The commenter included emerging
evidence of the efficacy of telehealth delivery of the services,
including research articles relevant to each service. The commenter
noted that no reports of significant adverse events or negative side
effects were noted in research; however, the commenter indicated that
when the assessment or treatment services targeted behaviors in
patients with developmental disabilities that carried risk of harm, the
supervising behavior analysts (QHPs) had the behavior technicians or
caregivers who delivered the services take precautions to protect
patients.
A commenter agreed there may be concern that some patients may not
be able to be fully assessed via interactive audio-visual technology;
however, they stated that the benefits of furnishing these services via
telehealth outweigh the concerns. The commenter also noted that the
decision as to the appropriateness of care should be determined by the
provider, without financial disincentives between in-person and
telehealth care. The commenter noted that there are significant
benefits to being able to provide these services via telehealth. The
commenter stated that patients with dementia or other cognitive or
psychological impairments may require the assistance of additional
parties
[[Page 69456]]
during a visit, and that providing these services remotely can allow
for inclusion of other people, including family, significant others,
and additional practitioners, who can provide substantial benefits.
According to the commenter, this is not always the case for in-person
visits, as caregivers and other family members may not be able to take
time off from work or travel to the appointments, and virtual visits
allow for the practitioner, the patient, and important family members
to be in separate locations while still being able to participate in
the visit. Additionally, the commenter noted that psychiatric patients
often have social anxiety issues, leading to limitations on leaving
safe places like their home, facility, or family, and remote visits are
important ways to ensure these patients maintain access to care.
A commenter did not support these services remaining on the
Medicare Telehealth Services List, stating such additions may pose
beneficiary safety and quality-of-care issues. The commenter urged us
to exercise extreme caution when adding additional mental-health-
related services to the Medicare Telehealth Services List on a
temporary basis, considering the unique challenges faced by persons
living with mental health conditions, and the multiple, system-wide
issues currently complicating the delivery of safe and effective mental
health care.
Response: We note that CPT codes 90853 and 96121 are already
permanently on the Medicare Telehealth Services List. Regarding CPT
codes 96130-96133, 97151-97158, 0362T, and 0373T, we continue to
believe our proposal to add these services on a Category 3 basis is
appropriate and preferable. Adding these CPT codes to the Medicare
Telehealth Services List on a Category 3 basis will allow for the
collection and evaluation of data that could potentially support
permanent inclusion on the Medicare Telehealth Services List, and we
look forward to evaluating such data in the future.
After consideration of public comments, we are finalizing our
proposal to retain CPT codes 97151-97158, 0362T, and 0373T on the
Medicare Telehealth Services List on a Category 3 basis.
c. Other Services Proposed for Addition to the Medicare Telehealth
Services List
As discussed above, there are services that are included on the
Medicare Telehealth Services List temporarily during the PHE for which
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition to the list under the Category 1 or
Category 2 criteria. In addition to the services we proposed for
addition to the Medicare Telehealth Services List on a Category 3 basis
in response to requests, we also proposed to add a number of services
to the Medicare Telehealth Services List on a Category 3 basis that are
currently included on the Medicare Telehealth Services List temporarily
during the PHE that were not specifically requested for permanent
addition. These services would be included on the Medicare Telehealth
Services List through 2023 to allow us time to evaluate data that may
support their permanent addition to the list on a Category 1 or
Category 2 basis.
The services we proposed for addition to the Medicare Telehealth
Services List temporarily on a Category 3 basis include CPT codes 90875
(Individual psychophysiological therapy incorporating biofeedback
training by any modality (face-to-face with the patient), with
psychotherapy (e.g., insight oriented, behavior modifying or supportive
psychotherapy); 30 minutes), 92012 (Ophthalmological services: medical
examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient),
92014 (Ophthalmological services: medical examination and evaluation,
with initiation or continuation of diagnostic and treatment program;
comprehensive, established patient, 1 or more visits), 92507 (Treatment
of speech, language, voice, communication, and/or auditory processing
disorder; individual), 94005 (Home ventilator management care plan
oversight of a patient (patient not present) in home, domiciliary or
rest home (e.g., assisted living) requiring review of status, review of
laboratories and other studies and revision of orders and respiratory
care plan (as appropriate), within a calendar month, 30 minutes or
more), 96105 (Assessment of aphasia (includes assessment of expressive
and receptive speech and language function, language comprehension,
speech production ability, reading, spelling, writing, e.g., by Boston
Diagnostic Aphasia Examination) with interpretation and report, per
hour), 96110 (Developmental screening (e.g., developmental milestone
survey, speech and language delay screen), with scoring and
documentation, per standardized instrument), 96112 (Developmental test
administration (including assessment of fine and/or gross motor,
language, cognitive level, social, memory and/or executive functions by
standardized developmental instruments when performed), by physician or
other qualified health care professional, with interpretation and
report; first hour), 96113 (Developmental test administration
(including assessment of fine and/or gross motor, language, cognitive
level, social, memory and/or executive functions by standardized
developmental instruments when performed), by physician or other
qualified health care professional, with interpretation and report;
each additional 30 minutes (List separately in addition to code for
primary procedure)), 96127 (Brief emotional/behavioral assessment
(e.g., depression inventory, attention-deficit/hyperactivity disorder
[ADHD] scale), with scoring and documentation, per standardized
instrument), 96170 (Health behavior intervention, family (without the
patient present), face-to-face; initial 30 minutes), 96171 (Health
behavior intervention, family (without the patient present), face-to-
face; each additional 15 minutes (List separately in addition to code
for primary service)), 97129 (Therapeutic interventions that focus on
cognitive function (e.g., attention, memory, reasoning, executive
function, problem solving, and/or pragmatic functioning) and
compensatory strategies to manage the performance of an activity (e.g.,
managing time or schedules, initiating, organizing, and sequencing
tasks), direct (one-on-one) patient contact; initial 15 minutes), 97130
(Therapeutic interventions that focus on cognitive function (e.g.,
attention, memory, reasoning, executive function, problem solving, and/
or pragmatic functioning) and compensatory strategies to manage the
performance of an activity (e.g., managing time or schedules,
initiating, organizing, and sequencing tasks), direct (one-on-one)
patient contact; each additional 15 minutes (List separately in
addition to code for primary procedure)), and 99473 (Self-measured
blood pressure using a device validated for clinical accuracy; patient
education/training and device calibration). Our analyses of these
services indicate that there is some evidence of possible clinical
benefit associated with these services when furnished via telehealth.
We believe these services can safely be furnished via real-time, audio
and visual interactive telecommunications under the circumstances of
the PHE, but there is not yet sufficient evidence available to consider
the services for permanent addition to the Medicare Telehealth Services
List under the Category 1 or Category 2 criteria.
[[Page 69457]]
Some audiology testing services are currently temporarily included
on the Medicare Telehealth Services List for the duration of the PHE.
These are CPT codes 92550 (Tympanometry and reflex threshold
measurements), 92552 (Pure tone audiometry (threshold); air only),
92553 (Pure tone audiometry (threshold); air and bone), 92555 (Speech
audiometry threshold;), 92556 (Speech audiometry threshold; with speech
recognition), 92557 (Comprehensive audiometry threshold evaluation and
speech recognition (92553 and 92556 combined)), 92563 (Tone decay
test), 92565 (Stenger test, pure tone), 92567 (Tympanometry (impedance
testing)), 92568 (Acoustic reflex testing, threshold), 92570 (Acoustic
immittance testing, includes tympanometry (impedance testing), acoustic
reflex threshold testing, and acoustic reflex decay testing), 92587
(Distortion product evoked otoacoustic emissions; limited evaluation
(to confirm the presence or absence of hearing disorder, 3-6
frequencies) or transient evoked otoacoustic emissions, with
interpretation and report), 92588 (Distortion product evoked
otoacoustic emissions; comprehensive diagnostic evaluation
(quantitative analysis of outer hair cell function by cochlear mapping,
minimum of 12 frequencies), with interpretation and report), 92601
(Diagnostic analysis of cochlear implant, patient younger than 7 years
of age; with programming), 92625 (Assessment of tinnitus (includes
pitch, loudness matching, and masking)), 92626 (Evaluation of auditory
function for surgically implanted device(s) candidacy or postoperative
status of a surgically implanted device(s); first hour), 92627
(Evaluation of auditory function for surgically implanted device(s)
candidacy or postoperative status of a surgically implanted device(s);
each additional 15 minutes (List separately in addition to code for
primary procedure)). We have received information that, during the PHE,
certain practitioners have developed the capacity to perform these
services using remote technology including specialized equipment inside
an audiometric soundproof booth. We believe that, in circumstances in
which such equipment is available at the originating site, these
services can be furnished in a way in which all of the elements of the
services are met and that there is likely to be a clinical benefit when
these services are furnished via telehealth. Therefore, we proposed to
add these services to the Medicare Telehealth Services List on a
Category 3 basis, which will allow these services to be available via
telehealth through the end of CY 2023. We solicited comments regarding
how widespread the availability of this remote technology is, and
whether interested parties believe these services can be furnished in a
way that does not jeopardize patient safety or quality of care when
these services are furnished remotely.
Additionally, as discussed in section II.F. of this final rule, we
proposed to create HCPCS codes G0316 (listed as GXXX1 in our proposed
rule)(Prolonged hospital inpatient or observation care evaluation and
management service(s) beyond the total time for the primary service
(when the primary service has been selected using time on the date of
the primary service); each additional 15 minutes by the physician or
qualified healthcare professional, with or without direct patient
contact (list separately in addition to CPT codes 99223, 99233, and
99236 for hospital inpatient or observation care evaluation and
management services). (Do not report G0316 on the same date of service
as other prolonged services for evaluation and management 99358, 99359,
993X0). (Do not report G0316 for any time unit less than 15 minutes)),
G0317 (listed as GXXX2 in our proposed rule) (Prolonged nursing
facility evaluation and management service(s) beyond the total time for
the primary service (when the primary service has been selected using
time on the date of the primary service); each additional 15 minutes by
the physician or qualified healthcare professional, with or without
direct patient contact (list separately in addition to CPT codes 99306,
99310 for nursing facility evaluation and management services). (Do not
report G0317 on the same date of service as other prolonged services
for evaluation and management 99358, 99359, 993X0,). (Do not report
G0317 for any time unit less than 15 minutes)), and G0318 (listed as
GXXX3 in our proposed rule) (Prolonged home or residence evaluation and
management service(s) beyond the total time for the primary service
(when the primary service has been selected using time on the date of
the primary service); each additional 15 minutes by the physician or
qualified healthcare professional, with or without direct patient
contact (list separately in addition to CPT codes 99345, 99350 for home
or residence evaluation and management services). (Do not report G0318
on the same date of service as other prolonged services for evaluation
and management 99358, 99359, 99417). (Do not report G0318 for any time
unit less than 15 minutes)) to describe prolonged services associated
with certain types of E/M services. These codes will be replacing
existing codes that describe prolonged services, specifically inpatient
prolonged services CPT codes 99356 (Prolonged service in the inpatient
or observation setting, requiring unit/floor time beyond the usual
service; first hour (List separately in addition to code for inpatient
or observation Evaluation and Management service)) and 99357 (Prolonged
service in the inpatient or observation setting, requiring unit/floor
time beyond the usual service; each additional 30 minutes (List
separately in addition to code for prolonged service)). These services
are similar to services currently on the Medicare Telehealth Services
List, such as CPT codes 99356 and 99357, which were added to the
Medicare Telehealth Services List on a Category 1 basis in the CY 2016
rule (80 FR 71060-71062), as well as O/O prolonged service HCPCS code
G2212 (Prolonged service in the inpatient or observation setting,
requiring unit/floor time beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service)),
which was added to the Medicare Telehealth Services List on a Category
1 basis in the CY 2021 rule (85 FR 84506). Similarly, we believe that
these proposed HCPCS G codes will be sufficiently similar to
psychiatric diagnostic procedures or O/O visits currently on the
Medicare Telehealth Services List to qualify for inclusion on the list
on a Category 1 basis. Therefore, we proposed to add proposed HCPCS
codes G0316, G0317, and G0318 to the Medicare Telehealth Services List
on a Category 1 basis.
Table 12 lists the services that we are finalizing for addition to
the Medicare Telehealth Services List on a Category 3 basis. Table 13
lists the services we are finalizing for permanent addition to the
Medicare Telehealth Services List on a Category 1 basis.
BILLING CODE 4150-28-P
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[GRAPHIC] [TIFF OMITTED] TR18NO22.017
BILLING CODE 4150-28-C
We received public comments on these other services that we
proposed for addition to the Medicare Telehealth Services List. The
following is a summary of the comments we received and our responses.
Comment: Many commenters supported the addition of many of these
services on a Category 3 basis.
Response: We appreciate the support for our proposals.
Comment: One commenter stated that ophthalmologic services (92002,
92004, 92012 and 92014) are generally covered via telehealth by other
insurance plans, including Medicare Advantage plans and the Veterans
Health Administration, and should also be available to Medicare
beneficiaries. Commenters supported the addition of CPT codes 92012 and
92014 on a Category 3 basis.
Response: We thank commenters for their support of our proposal,
and we are finalizing as proposed the addition of CPT codes 92012 and
92014 to the Medicare Telehealth Services List on a Category 3 basis.
We did not identify or propose CPT codes 92002 or 92004 as Medicare
telehealth in the proposed rule. As such, discussion of these codes is
outside the scope of this rule.
Comment: Regarding our comment solicitation related to patient
safety for audiology services, a commenter stated that there is now
strong evidence confirming that patients who receive therapy services
via telehealth have similar, or even better outcomes, compared to
patients who received traditional in-person therapy services (including
citations of studies). This commenter cited this evidence in urging us
to add these services permanently. A commenter stated that the
Veteran's Administration has shown, for many years, that audiology
services can be safely provided, via telehealth, without sacrificing
patient outcomes or quality of care, and that the technology required
to perform these procedures via telehealth, in many cases with the
assistance of an audiology assistant or technician at a remote
location, is readily available. Commenters requested that many
audiology services that are not currently available on the Medicare
Telehealth Services List be added on a Category 3 basis.
Response: We appreciate the information provided by commenters, and
we may consider this information in future rulemaking. Given support of
commenters, as well as information provided, we are finalizing the
addition of audiology CPT codes 92550, 92552, 92553, 92555, 92556,
92557, 92563, 92565, 92567, 92568, 92570, 92587, 92588, 92601, 92625,
92626, and 92627 to the Medicare Telehealth Services List on a Category
3 basis, as proposed.
Comment: Commenters supported the addition of the proposed
prolonged services HCPCS codes G0316-G0318 permanently on a Category 1
basis, stating that doing so is essential to maintaining consistency
with the new coding and payment structure for inpatient E/M services.
Response: We appreciate commenters' support for this proposal. We
are finalizing the addition of HCPCS codes G0316, G0317, and G0318 to
the Medicare Telehealth Services List on a Category 1 basis, as
proposed.
Comment: Numerous commenters requested that we add many services
that are temporarily available for the PHE to the Medicare Telehealth
Services List that are currently on the list on a temporary basis, but
that we did not propose to continue on the list to be available as
Medicare telehealth services be added on a Category 3 basis
Response: As discussed above, we identified the services we
considered appropriate for addition to the Medicare Telehealth Services
List on a Category 3 basis by conducting an internal review to assess
those services that may, outside of the circumstances of the PHE, be
furnished using the full scope of service elements for their respective
service/code via two-way, audio-video communication technology, as
though the service were provided in-person. The commenters did not
present new information indicating that our analysis was incomplete.
Furthermore, because we did not propose to add the services requested
by these commenters to the Medicare Telehealth Services List on a
Category 3 basis, we found these comments to be outside the scope of
the proposed rule.
As discussed in section II.E. of this final rule, we proposed to
create two HCPCS G-codes to describe monthly Chronic Pain Management
and Treatment services: HCPCS code G3002 (Chronic pain management and
treatment, monthly bundle including, diagnosis; assessment and
monitoring; administration of a validated pain rating scale or tool;
the development, implementation, revision, and/or maintenance of a
person-centered care plan that includes strengths, goals, clinical
needs, and desired outcomes; overall treatment management; facilitation
and coordination of any necessary behavioral health treatment;
medication management; pain and health literacy counseling; any
necessary chronic pain related crisis care; and ongoing communication
and care coordination between relevant practitioners furnishing e.g.
physical therapy and occupational therapy, complementary and
integrative approaches, and community-based care, as appropriate.
Required initial face-to-face visit at least 30 minutes provided by a
physician or other qualified health professional; first 30 minutes
personally provided by physician or other qualified health care
professional, per calendar month. (When using G3002, 30 minutes must be
met or exceeded.)) and HCPCS code G3003 (Each additional 15 minutes of
chronic pain management and treatment by a physician or other qualified
health care professional, per calendar month (List separately in
addition to code for G3002). (When using G3003, 15 minutes must be met
or exceeded.)).
Comment: As discussed in section II.E.4.(33) in the CY 2023 PFS
proposed rule, we solicited comment regarding how best the initial
visit and subsequent visits should be conducted (for example, in-
person, via telehealth, or the use of a telecommunications system, and
any implications for additional or different coding). We also
considered whether to add the CPM codes to the Medicare
[[Page 69460]]
Telehealth Services List. Many commenters asked us to add CPM services
to the Medicare Telehealth Services List. One commenter stated that the
CPM code(s) would be appropriate to add on a Category 1 basis, since
chronic pain limits patient mobility and a ``silver lining'' of the
COVID-19 pandemic is that telehealth flexibilities improved access to
pain care. This commenter continued that it can be very burdensome for
patients, especially those with ``high impact'' chronic pain, to
physically get to doctor appointments, undergo the hardship of driving,
walking distances, standing in line, and sitting for long periods in
waiting rooms, all of which may exacerbate pain that has been ongoing
for days to weeks. The commenter emphasized how important access to
telehealth is for this particular group of Medicare patients and urged
us to add it to the Medicare Telehealth Services List. One commenter
stated that telehealth should be an option, because of geographic
factors (rural dwellers are underserved) and life circumstances (child
care, transportation), which can make repeated in-person appointments
inaccessible. This commenter continued that people with chronic pain
can experience challenging issues traveling to see a clinician, and
often inquire about the availability of receiving integrative care
through telehealth. For these reasons, this commenter recommended that
we add the CPM services to the Medicare Telehealth Services List. One
commenter stated they believed that telehealth increases self-efficacy
in people living with pain. As a middle pathway, another commenter
requested that we allow providers to use their discretion when
determining if telehealth is appropriate for their patient. Another
commenter added that telehealth visits should always be with the
agreement of the patient as some people are more comfortable with face-
to-face interactions. One commenter noted telehealth is appropriate
once patients are established on their care plan, while another
commenter suggested that at minimum, telehealth be allowed for all
follow up visits.
Response: As discussed earlier in this section, we agree with the
commenter's suggestion to add CPM services to the Medicare Telehealth
Services List on a Category 1 basis. We believe that the interactions
between the furnishing practitioner and the beneficiary described by
the required face-to-face visit component of the CPM services are
sufficiently similar to professional consultations, office visits, and
office psychiatry services currently on the Medicare Telehealth
Services List for these services to be added on a Category 1 basis. By
its nature, and because of the many treatment challenges described by
these and other commenters in section II.E.4.(33), pain care is ideally
suited to telehealth, and we believe appropriate to be furnished
through interactive, real-time telecommunications technology. Like
certain other non-face-to face PFS services, there are also components
of HCPCS codes G3002 and G3003 describing care planning or care
coordination with other health care professionals that are commonly
furnished remotely using telecommunications technology, and do not
require the patient to be present/in-person with the practitioner when
they are furnished. As such, these components of HCPCS codes G3002 and
G3003 are not considered telehealth services for purposes of Medicare,
and we do not need to consider whether the non-face-to-face aspects of
HCPCS codes G3002 and G3003 are similar to other telehealth services.
We are finalizing in this rule that any of the CPM in-person components
included in HCPCS codes G3002 and G3003 may be furnished via
telehealth, as clinically appropriate, in order to increase access to
care for beneficiaries. However, we reiterate as provided in the code
descriptor that the initial CPM services visit billed under HCPCS code
G3002 must be furnished in-person without the use of telecommunications
technology. (For further clarification about the initial in person
visit requirements, please see section II.E.4.(33).)
Comment: One commenter asked that we enable the CPM codes, in
addition to being rendered through telehealth, to be furnished through
audio-only technology.
Response: We appreciate the comment. In the CY 2022 PFS final rule,
we finalized a policy to revise the definition of ``telecommunications
system'' at Sec. 410.78(a)(3) to allow the use of audio-only
technology for the diagnosis, evaluation, or treatment of mental health
conditions under certain circumstances (described in detail at 86 FR
64996, 65056 through 65060) that allow visits and other services
furnished via audio-only technology to be reported as Medicare
telehealth services, with the appropriate modifier. We acknowledge that
certain scope of service aspects of CPM may pertain to the diagnosis,
evaluation, or treatment of mental health conditions. We expect
clinicians will bill for the HCPCS code that most accurately describes
the services furnished, including in instances where the service being
furnished might determine the technological modality used to deliver
the service.
After consideration of public comments, we are finalizing our
proposal to add CPT codes 90875, 92012, 92014, 92507, 94005, 96105,
96110, 96112, 96113, 96127, 96170, 96171, 97129, 97130, and 99473 to
the Medicare Telehealth Services List on a Category 3 basis, and
finalizing our proposal to add HCPCS codes G0316, G0317, and G0318,
G3002, and G3003 to the Medicare Telehealth Services List on a Category
1 basis.
d. Services Proposed for Removal From the Medicare Telehealth Services
List After 151 Days Following the End of the PHE
As we noted in the CY 2022 PFS final rule (86 FR 65054), at the
conclusion of the PHE for COVID-19, the associated waivers and interim
policies will expire, payment for Medicare telehealth services will
once again be limited by the requirements of section 1834(m) of the
Act, and we will return to the policies established through our regular
notice-and-comment rulemaking process, through which we established and
maintain the Medicare Telehealth Services List. Services that have been
added to the Medicare Telehealth Services List on a Category 3 basis
will remain on the list through the end of CY 2023. We have explained
that under our current policy, all other services that were temporarily
added to the Medicare Telehealth Services List on an interim basis
during the PHE and have not been added to the Medicare Telehealth
Services List on a Category 1, 2, or 3 basis will not remain on the
list after the end of the PHE (85 FR 84506-84509). As explained in
section II.D.1.e. of this final rule, Division P, Title III, Subsection
A of the Consolidated Appropriations Act, 2022 (CAA, 2022), extends
some of the flexibilities implemented during the PHE for COVID-19 for
an additional 151 days after the end of the PHE, including section
301(a) of Division P, Title III, Subtitle A of the CAA, 2022, which
specifies that, for services on the Medicare Telehealth Services List
as of the date of enactment (March 15, 2022) furnished during 151 days
after the end of the PHE, the originating site for the telehealth
service can be any site in the United States at which the beneficiary
is located when the service is furnished, including the beneficiary's
home. To give full effect to this provision, we believe it is necessary
to continue to include the services on the Medicare Telehealth Services
List through the 151-day period after the end of the PHE that were
temporarily added to the list
[[Page 69461]]
during the PHE but have not since been added on a Category 3 or other
basis, and which are currently set to be removed from the list at the
end of the PHE. As such, we proposed to continue to include on the
Medicare Telehealth Services List the services that are currently set
to be removed from the list when the PHE ends (that is, those not
currently added to the list on a Category 1, 2, or 3 basis) for an
additional 151 days after the PHE ends. Table 14 lists those services
that are temporarily included on the list available for the PHE, which
we proposed to retain on the Medicare Telehealth Services List for an
additional 151 days following the end of the PHE. The services listed
in Table 14 will no longer be available on the Medicare Telehealth
Services List on the 152nd day after the end of the PHE. As previously
explained, on the 152nd day after the end of the PHE, payment for
Medicare telehealth services will once again be limited by the
requirements of section 1834(m) of the Act, as aforementioned, and
telehealth claims for these services furnished on or after the codes
are removed from the list will be denied. We proposed to align the
temporary availability of services available as Medicare telehealth
services until the end of the PHE with the 151-day extensions of
flexibilities enacted in the CAA, 2022 in order to simplify the process
of ending the PHE-related flexibilities and to minimize possible
errors.
Comment: A commenter noted that CPT code 94664 did not appear in
Table 10 of the proposed rule despite being a code that was temporarily
added for the PHE.
Response: We agree that CPT code 94664 was inadvertently omitted
from Table 10 of the proposed rule. As a code that was temporarily
added to the Medicare Telehealth Services List for the duration of the
PHE, it should have been included among codes that we proposed will
remain on the Medicare Telehealth Services List for an additional 151
days following the end of the PHE. We have corrected this error in
Table 14, and we are finalizing that CPT code 94664 will remain on the
Medicare Telehealth Services List for an additional 151 days following
the end of the PHE.
Comment: Many commenters supported our proposal to align the period
of availability for services that are temporarily available for the
duration of the PHE with the 151-day extension of certain telehealth
flexibilities associated with the CAA, 2022. Some commenters stated
that we should eliminate the temporary designation for all services on
the Medicare Telehealth Services List, making permanent all services
currently available.
Response: We thank commenters for their support of our proposal to
allow services that would be available for the duration of the PHE to
remain on the Medicare Telehealth Services List through the 151-day
period following the end of the PHE. We continue to believe that
services, including those that we added on a temporary interim basis
for the PHE for COVID-19, should be considered for permanent addition
to the Medicare Telehealth Services List through the regular annual
process we established as required by section 1834(m)(4)(F)(ii) of the
Act. While we have included some services on the Medicare Telehealth
Services List on a temporary Category 3 basis through the end of CY
2023, this was to allow for the continued development of data to
support their potential future consideration for permanent addition to
the list on a Category 1 or Category 2 basis; we review all items on
the Medicare Telehealth Services List each year as per our established
process. Interested parties may continue to use the annual submission
process to request the addition of any services to or deletion of
services from the Medicare Telehealth Services List, regardless of
whether the service was added on a temporary Category 3 basis. We note
that the services that are included on the Medicare Telehealth Services
list on a Category 3 basis will remain on the list for an additional
period beyond 151 days after the end of the PHE, which is currently
through the end of 2023. We understand that, if the PHE is in effect
for most of the year next year, the 151-day period after the PHE may
end on a date that is beyond December 31, 2023. We clarify that in this
instance, the Category 3 services would remain on the Medicare
Telehealth Services List through December 31, 2023 or 151 days after
the PHE, if later. We will consider whether any additional extensions
are needed in the future.
[[Page 69462]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.018
e. Implementation of Telehealth Provisions of the Consolidation
Appropriations Acts, 2021 and 2022
As discussed in the CY 2021 PFS final rule (85 FR 84506),
legislation enacted to address the PHE for COVID-19 provided the
Secretary with new authorities under section 1135(b)(8) of the Act, as
added by section 102 of the Coronavirus Preparedness and Response
Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020)
and subsequently amended by section 6010 of the Families First
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section
3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES
Act) (Pub. L. 116-136, March 27, 2020), to waive or modify Medicare
telehealth payment requirements during the PHE for COVID-19. We used
these authorities to establish several flexibilities to accommodate
changes in the delivery of care during the PHE. Through waiver
authority under section 1135(b)(8) of the Act, in response to the PHE
for COVID-19, we removed the geographic and site of service originating
site restrictions in section 1834(m)(4)(C) of the Act, as well as
restrictions in section 1834(m)(4)(E) of the Act on the types of
practitioners who may furnish telehealth services, for the duration of
the PHE for COVID-19. We also used waiver authority to allow certain
telehealth services to be furnished via audio-only communication
technology. At the end of the PHE for COVID-19, these waivers and
interim policies will expire, and payment for Medicare telehealth
services will once again be limited by the requirements of section
1834(m) of the Act.
Section 1834(m)(7) of the Act (as added by section 2001(a) of the
SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24,
2018)), removes the geographic restrictions under section
1834(m)(4)(C)(i) of the Act and authorizes the patient's home as a
permissible originating site, for telehealth services furnished for
purposes of treatment of a substance use disorder (SUD) or a co-
occurring mental health disorder, furnished on or after July 1, 2019,
to an individual with a SUD diagnosis. Section 123(a) of Division CC of
the Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260,
December 27, 2020) amended section 1834(m)(7)(A) of the
[[Page 69463]]
Act to broaden the scope of services for which the geographic
restrictions under section 1834(m)(4)(C)(i) of the Act do not apply and
for which the patient's home is a permissible originating site to
include telehealth services furnished for the purpose of diagnosis,
evaluation, or treatment of a mental health disorder, effective for
services furnished on or after the end of the PHE for COVID-19. Section
123(a) of the CAA, 2021 also added subparagraph (B) to section
1834(m)(7) of the Act to prohibit payment for a telehealth service
furnished in the patient's home under paragraph (7), unless the
physician or practitioner furnishes an item or service in-person,
without the use of telehealth, within 6 months prior to the first time
the physician or practitioner furnishes a telehealth service to the
beneficiary, and thereafter, at such times as the Secretary determines
appropriate. For a full discussion of our implementation of section
123(a) of the CAA, 2021, refer to our CY 2022 PFS final rule (86 FR
64996).
In the proposed rule, we proposed to implement provisions of
section 1834(m) of the Act (including the amendments made by the CAA,
2021) and provisions of the CAA, 2022 that extend certain Medicare
telehealth flexibilities adopted during the PHE for 151 days after the
end of the PHE.
Sections 301, 302, 303, 304, and 305 of Division P, Title III,
Subtitle A of the CAA, 2022 amended section 1834(m) of the Act to
generally extend certain PHE-related telehealth policies for services
that are on the Medicare Telehealth Services List as of the date of
enactment (March 15, 2021). Specifically, section 301(a) of the CAA,
2022 amended section 1834(m)(4)(C) of the Act to add a new clause
(iii), which temporarily expands the scope of telehealth originating
sites for those services to include any site in the United States where
the beneficiary is located at the time of the telehealth service,
including an individual's home, for a 151-day period beginning on the
first day after the end of the PHE for COVID-19. Section 301(a) also
amended section 1834(m)(7)(A) of the Act to apply the expanded scope of
telehealth originating site policy to include any location in the
United States in new clause (iii) of section 1834(m)(4)(C) of the Act
during the 151-day period for telehealth services furnished for the
purposes of diagnosis, evaluation, or treatment of a mental health
disorder and to individuals with a SUD diagnosis for purposes of
treatment of the SUD or a co-occurring mental health disorder for this
151-day post-PHE extension period. In addition to this provision,
section 301(b) of the CAA, 2022 amended section 1834(m)(2)(B) of the
Act to add a new clause (iii) that allows payment of an originating
site facility fee to an originating site with respect to those
telehealth services furnished during the 151-day period only if the
originating site is one that meets the geographic requirements in
section 1834(m)(4)(C)(i) of the Act, and is a setting included on the
enumerated list of originating sites under section 1834(m)(4)(C)(ii) of
the Act (other than the patient's home).
Section 302 of the CAA, 2022 amended section 1834(m)(4)(E) of the
Act to temporarily expand the definition of eligible telehealth
practitioners for the 151-day period beginning on the first day after
the end of the PHE for COVID-19 to include qualified occupational
therapists, qualified physical therapists, qualified speech-language
pathologists, and qualified audiologists.
Section 303 of the CAA, 2022 amended section 1834(m)(8) of the Act
to temporarily continue payment for telehealth services furnished by
FQHCs and RHCs for the 151-day period beginning on the first day after
the end of the COVID-19 PHE using the methodology established for
telehealth services furnished by FQHCs and RHCs during the PHE, which,
in accordance with section 1834(m)(8)(B) of the Act, is based on
payment rates that are similar to the national average payment rates
for comparable telehealth services under the PFS.
Section 304(a) of the CAA, 2022 amended section 1834(m)(7)(B)(i) of
the Act to delay the requirement for an in-person visit with the
physician or practitioner within 6 months prior to the initial mental
health telehealth service, and again at subsequent intervals as the
Secretary determines appropriate. In light of this amendment, the in-
person requirements for telehealth services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder will
again be effective on the 152nd day after the PHE ends. In addition,
section 304(b) and (c) of the CAA, 2022 modified sections 1834(y) and
1834(o)(4) of the Act, respectively, to similarly delay in-person visit
requirements for mental health visits furnished by Rural Health Clinics
and Federally Qualified Health Centers via telecommunications
technology. Therefore, we proposed to revise the regulatory text at
Sec. 410.78(b)(3)(xiv) to recognize the delay of the in-person
requirements for mental health visits furnished by RHCs and FQHCs
through telecommunication technology under Medicare until the 152nd day
after the PHE for COVID-19, to conform with the statute. See section
II.B.3. of this final rule for our proposal to implement similar
changes for RHC and FQHC mental health visits.
Finally, section 305 of the CAA, 2022 added a new paragraph (9) to
section 1834(m) of the Act to require the Secretary to continue to
provide for coverage and payment of telehealth services included on the
Medicare Telehealth Services List as of the March 15, 2022, date of
enactment that are furnished via an audio-only telecommunications
system during the 151-day period beginning on the first day after the
end of the PHE for COVID-19. The new paragraph applies only to
telehealth services specified on the Medicare Telehealth Services List
under section 1834(m)(4)(F)(i) of the Act that are designated to as
eligible to be furnished via audio-only technology as of the date of
enactment of the CAA, 2022 (that is, March 15, 2022). These are the
services for which CMS waived the requirements of section 1834(m)(1) of
the Act and the first sentence of Sec. 410.78(a)(3) for use of
interactive telecommunications systems to furnish telehealth services,
to the extent they require use of video technology, during the PHE.
Under this waiver, CMS permitted the audio-only telephone E/M services
and certain behavioral health counseling and educational services to be
furnished via audio-only equipment during the PHE for COVID-19. We
proposed to continue to make payment for services included on the
Medicare Telehealth Services List as of March 15, 2022 that are
furnished via an audio-only telecommunications system for the 151-day
period beginning on the first day after the end of the PHE. We read
section 305 of the CAA, 2022 to require that we continue to make
payment for services furnished via audio-only telecommunications
systems (each described by a HCPCS code, including their successor
codes) for the 151-day period after the end of the PHE. These services
include certain behavioral health, counseling, and educational
services. (https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf, n.d.). A list of the services that involve
audio-only interaction but are included on the Medicare Telehealth
Services List for the duration of the PHE is available at the CMS
website, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
Section 309 of Division P, Title III, Subtitle A of the CAA, 2022
authorizes the Secretary to implement the amendments described above
made by
[[Page 69464]]
sections 301 through 305 through program instruction or otherwise.
Given that the end date of the PHE is not yet known and could occur
before the rulemaking process for the CY 2023 PFS is complete, and that
the changes made by these provisions are very specific and concise, we
announced in the CY 2023 PFS proposed rule that we intended to issue
program instructions or other subregulatory guidance to effectuate the
changes described above, other than the proposed revisions to Sec.
410.78. We intend to issue these instructions in the near future. We
believe this approach will serve to ensure a smooth transition after
the end of the PHE for COVID-19.
We received public comments on our proposals to implement section
304(a) of the CAA, 2022, which amended section 1834(m)(7)(B)(i) of the
Act, regarding the requirement that an in-person visit with the
physician or practitioner must occur within 6 months prior to the
initial mental health telehealth service. The following is a summary of
the comments we received and our responses.
In-Person Requirements
Comment: Many commenters expressed general support for our
proposals to implement and effectuate changes via program instructions,
and subregulatory guidance, based on the fact that the last day of the
PHE remains uncertain, but varied in their level of concern about
whether the post-PHE transition period, of 151 days, would allow enough
flexibility. Commenters expressed concerns that a sudden shift in the
in-person visit requirements, beginning 152 days after the end of the
PHE, could create beneficiary access issues, additional strain on the
existing health care workforce shortage, and significant confusion
among clinical and administrative staff about how to align resources
and inform beneficiaries. Some commenters noted that the public will
receive only 60 days' notice before the last day of the PHE, which they
believe would not allow adequate time to coordinate in-person care
across many different settings of care and varied individual
beneficiary needs. A few commenters suggested that CMS should take the
narrowest interpretation of the intent of Congress for in-person visit
requirements prior to the initial mental health telehealth service, on
the basis that the Secretary has the authority to specify the
requirements associated with the required interval for similar follow-
up in-person visit requirements. Other commenters expressed confusion
about how individual physicians or practitioners would ensure
appropriate record keeping and overall compliance plans would be
updated to provide a means of verifying that any individual service met
the in-person visit requirements. Some commenters whose focus is on
enabling and supporting telehealth care through various health IT
solutions requested that CMS provide more specifics on timing and
possible ways to standardize the means by which individual physicians
or practitioners document compliance with in-person requirements.
We also received comments that outlined concerns or possible risks
to patient safety when patients with certain mental health conditions
were treated remotely. These commenters provided examples of high-risk
circumstances, such as possible risks associated with treating complex,
or atypical patients, via telehealth. Commenters discussed that care of
certain patients, who may have a severe or rare diagnosis, may also be
under a course of treatment, where that plan of care includes a
medication regimen that requires close monitoring. Alternatively, one
commenter mentioned that certain beneficiaries with significant complex
needs may demonstrate possible outcomes that may be superior when
delivered via telehealth versus in-person. We also received a broad
range of comments suggesting varied ways that CMS could implement the
in-person visit requirements for mental health telehealth services.
Response: We appreciate these commenters' feedback. We did not
propose to modify our established policies to implement these in-person
visit requirements (except as it pertains to the 151-day extension for
the 6-month requirement for an in-person visit for mental health
treatment). We recognize that the CAA, 2022 delays implementation of
the in-person visit requirements for mental health telehealth services
for a period of 151 days after the final day of the PHE. As explained
above and in the proposed rule, we are implementing section 304(a) of
the CAA, 2022. and further emphasize that the availability of
furnishing these services via telehealth does not preclude
practitioners from seeing patients in-person, when indicated. We will
continue to gather information on these mental health telehealth
services as they are utilized, and we will take this information into
consideration in the future for possible rulemaking.
Comment: Several commenters suggested that no in-person requirement
should be enforced at all.
Response: We appreciate commenters' feedback. The statute does
require an in-person, non-telehealth visit within 6 months prior to the
first mental health services furnished via Medicare telehealth.
However, we clarify that we do not believe this requirement applies to
beneficiaries who began receiving mental health telehealth services in
their homes during the PHE. In other words, if a beneficiary began
receiving mental health telehealth services during the PHE or during
the 151-day period after the end of the PHE, then they would not be
required to have an in-person visit within 6 months; rather, they will
be considered established and will instead be required to have at least
one in-person visit every 12 months (so long as any such subsequent
telehealth service is furnished by the same individual physician or
practitioner (or a practitioner of the same sub-specialty in the same
practice) to the same beneficiary). This means that these services
would be subject to the requirement that an in-person visit is
furnished within 12 months of each mental health telehealth service for
those services that are subject to in-person visit requirements (unless
an exception is documented by their treating practitioner). For
discussion of additional requirements for these services, please see
the discussion in the CY 2022 PFS final rule.
f. Use of Modifiers for Medicare Telehealth Services Following the End
of the PHE for COVID-19
Prior to CY 2017, Medicare telehealth services furnished via
interactive audio and video telecommunications systems were reported
using the GT modifier. In the CY 2017 PFS Final Rule, CMS finalized
creation of a new Place of Service (POS) code for Medicare telehealth,
POS ``02'' (81 FR 80199-80201). When a physician or practitioner
submits a claim for their services, including claims for telehealth
services, they include a place of service (POS) code that is used to
determine whether a service is paid using the facility or non-facility
rate. Under the PFS, there are two payment rates for many physicians'
services: the facility rate and the non-facility (or office) rate. The
PFS non-facility rate is the single amount paid to a physician or other
practitioner for services furnished in their office. The PFS facility
rate is the amount generally paid to a professional when a service is
furnished in a setting of care, like a hospital, where Medicare is
making a separate payment to a facility entity in addition to the
payment to the billing physician or practitioner. This separate
payment, often referred to as a ``facility fee,'' reflects the
facility's costs associated with the service (clinical staff, supplies,
[[Page 69465]]
and equipment) and is paid in addition to what is paid to the
professional under the PFS. POS ``02'' indicates that the service was
furnished via telehealth, and under the pre-PHE process, was then paid
at the facility payment rate.
As discussed in the March 31, 2020 IFC, (refer to 85 FR 19230), we
stated that, as physician practices suddenly transitioned a potentially
significant portion of their services from in-person to telehealth
visits in the context of the PHE for the COVID-19 pandemic, the
relative resource costs of furnishing these services via telehealth may
not significantly differ from the resource costs involved when these
services are furnished in-person. Therefore, we instructed physicians
and practitioners who bill for Medicare telehealth services to report
the POS code that would have been reported had the service been
furnished in-person. This will allow our systems to make appropriate
payment for services furnished via Medicare telehealth, which, if not
for the PHE for the COVID-19 pandemic, would have been furnished in-
person, at the same rate they would have been paid if the services were
furnished in-person. In order to effectuate this change, we finalized
on an interim basis (85 FR 19233) the use of the CPT telehealth
modifier, modifier ``95'', for the duration of the PHE for COVID-19,
which should be applied to claim lines that describe services furnished
via telehealth and that the practitioner should report the POS code
where the service would have occurred had it not been furnished via
telehealth.
We further noted that we are maintaining the facility payment rate
for services billed using the general telehealth POS code ``02'',
should practitioners choose to maintain their current billing practices
for Medicare telehealth during the PHE for the COVID-19 pandemic.
We proposed that Medicare telehealth services furnished on or
before the 151st day after the end of the PHE, in alignment with the
extensions of telehealth-related flexibilities in the CAA, 2022, will
continue to be processed for payment as Medicare telehealth claims when
accompanied with the modifier ``95.'' We further proposed that
physicians and practitioners can continue to report the place of
service code that would have been reported had the service been
furnished in-person during the 151-day period after the end of the PHE,
as finalized on an interim basis in the March 31 IFC (85 FR 19233). We
proposed that Medicare telehealth services performed with dates of
service occurring on or after the 152nd day after the end of the PHE
will revert to pre-PHE rules and will no longer require modifier ``95''
to be appended to the claim, but the appropriate place of service (POS)
indicator will need to be included on the claim to be processed for
payment as Medicare telehealth claims in order to properly identify the
place where the service was furnished. We further proposed that, for
Medicare telehealth services furnished on or after the 152nd day after
the end of the PHE, the POS indicators for Medicare telehealth will be:
POS ``02''--is redefined as Telehealth Provided Other than
in Patient's Home (Descriptor: The location where health services and
health related services are provided or received, through
telecommunication technology. Patient is not located in their home when
receiving health services or health related services through
telecommunication technology.); and
POS ``10''--Telehealth Provided in Patient's Home
(Descriptor: The location where health services and health related
services are provided or received through telecommunication technology.
Patient is located in their home (which is a location other than a
hospital or other facility where the patient receives care in a private
residence) when receiving health services or health related services
through telecommunication technology.).
We remind readers that we defined ``home'' in our CY 2022 PFS final
rule (86 FR 65059) to include, as: ``both in general and for this
purpose, a beneficiary's home can include temporary lodging, such as
hotels and homeless shelters. We also clarified that for circumstances
where the patient, for privacy or other personal reasons, chooses to
travel a short distance from the exact home location during a
telehealth service, the service is still considered to be furnished `in
the home of an individual' for purposes of section 1834(m)(4)(C)(ii)(X)
of the Act.''
In our proposed rule, we discussed that, once the flexibilities for
the geographic restrictions and the site of service waivers for
Medicare telehealth services expire (on the 152nd day after the end of
the PHE, per the CAA, 2022), POS ``02'' would once again be required
for all Medicare telehealth claims (with the exception of certain
Medicare telehealth for mental health services). In the proposed rule,
we noted that the exceptions include claims for Medicare telehealth
mental health telehealth services, clinical assessments for patients
with ESRD that are receiving home dialysis, and Medicare telehealth
treatment of an SUD or mental health services that are co-occurring
mental health disorder with substance use treatment that are furnished
to with the patient in their home (that is, the originating site is in
a private residence and not a hospital or other facility setting), in
which case POS ``10'' could be used by the billing practitioner. In our
proposed rule, we further discussed that, on or after the 152nd day
after the PHE has expired, payment for Medicare telehealth services
using either of the Medicare telehealth POS codes would be made at the
PFS facility payment rate, in accordance with established PFS policy
outside the circumstances of the PHE. We proposed to align payment for
those telehealth services described as taking place in the
beneficiary's home, using POS ``10'' for Medicare telehealth, and those
services not provided in a patient's home, using POS ``02'' for
Medicare telehealth, to be made at the same facility payment amount. We
believe that the facility payment amount best reflects the practice
expenses, both direct and indirect, involved in furnishing services via
telehealth (please see section II.B. of this final rule for further
discussion regarding practice expense).
We further proposed that, beginning January 1, 2023, a physician or
other qualified health care practitioner billing for telehealth
services furnished using audio-only communications technology shall
append CPT modifier ``93'' (Synchronous Telemedicine Service Rendered
Via Telephone or Other Real-Time Interactive Audio-Only
Telecommunications System: Synchronous telemedicine service is defined
as a real-time interaction between a physician or other qualified
health care professional and a patient who is located away at a distant
site from the physician or other qualified health care professional.
The totality of the communication of information exchanged between the
physician or other qualified health care professional and the patient
during the course of the synchronous telemedicine service must be of an
amount and nature that is sufficient to meet the key components and/or
requirements of the same service when rendered via a face-to-face
interaction) to Medicare telehealth claims (for those services for
which the use of audio-only technology is permitted under Sec.
410.78(a)(3)), to identify them as having been furnished using audio-
only technology. We noted that we have also instructed all relevant
providers, including RHCs, FQHCs, and OTPs to append Medicare modifier
``FQ'' (Medicare telehealth service was furnished using audio-only
[[Page 69466]]
communication technology) for allowable audio-only services furnished
in those settings; however, consistent with our proposal for audio-only
services furnished under the PFS, we also proposed to require all
relevant providers, including RHCs, FQHCs, and OTPs to use modifier
``93'' when billing for eligible mental health services furnished via
audio-only telecommunications technology. We believe that using
modifier ``93'', which is a CPT modifier, will simplify billing, as
this modifier is used by payers outside of Medicare. Currently, these
modifiers can only be applied to Medicare telehealth mental health
services and those telehealth services for the treatment of a SUD or a
co-occurring mental health disorder when the originating site is the
beneficiary's home.
Supervising practitioners continue to be required to append the
``FR'' modifier on any applicable telehealth claim when they provide
direct supervision for a service using virtual presence through real-
time, audio and video telecommunications technology.
Comment: Some commenters expressed concern regarding our proposed
approach to the use of modifiers for billing of Medicare telehealth
services. One commenter noted that we had inadvertently overlooked the
fact that after the transition period, facility-based providers would
not be able to bill using the POS code fields, as the CMS-1450 (UB-04)
institutional claim form does not permit use of POS code fields. The
commenter noted that this may have been an oversight.
Response: We thank commenters for offering feedback on technical
issues associated with our proposed policies for use of modifiers that
allow claims processing and billing for professional services under
Part B, which includes Medicare telehealth services. We reiterate that
151 days after the end of the PHE, Medicare telehealth services will
once again be subject to the statutory requirements in section 1834(m)
of the Act. As such, only physicians and the practitioners specified in
section 1834(m)(4)(E) of the Act will be able to serve as distant site
practitioners to furnish and bill for Medicare telehealth services, and
those services would be billed on the professional, not the
institutional, claim form. Thus, beginning on the 152nd day after the
PHE ends, only certain types of practitioners will be permitted to
furnish and bill for Medicare telehealth services, and none of those
practitioners would be ``facility-based providers.''
Comment: Many commenters requested that we continue to allow for
services that would have been furnished in a non-facility setting
outside of the circumstances of the PHE to be billed at the non-
facility rate for telehealth services following the end of the PHE.
Commenters stated that they were concerned that reverting to the
facility rate for telehealth services will lead practitioners to offer
telehealth less frequently and inhibit access. According to these
commenters, many patients in rural and underserved areas are now able
to access mental health services, often for the first time. Many
commenters emphasized their concerns that mental health services would
be particularly impacted, as there is already high demand for these
services and relatively low numbers of available practitioners.
One commenter requested that we maintain payment at the non-
facility-based rate for telehealth services furnished in office
settings through the end of 2023, stating that changing payment to the
facility rate would result in a nearly 30 percent cut for some
services, which they believed will harm access to telehealth services.
Some commenters, including MedPAC, expressed concern that payment
at the facility rate will create the unintended effects of shifting
beneficiaries toward both higher intensity and volume of virtual care
modalities that would be inappropriate for beneficiaries. In MedPAC's
comment, they offered their March 2022 MedPAC Report to Congress
(https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_v2_SEC.pdf), which noted that Medicare
spending can be sensitive to shifts in the site of care, and that the
negative impact of the pandemic on E/M services may have been more
significant in 2020 were it not for Medicare telehealth.
Some commenters, including MedPAC, provided examples and
explanations that raised questions about uncertainty of clinical
benefit and possible overpayment for Medicare telehealth and offered
evidence that many patients who used telehealth during the PHE would
prefer in-person visits, once it is safe to do so.
Response: We acknowledge the commenters' concerns. We note that
there are many nuances to this issue, and we seek to minimize confusion
and practitioner burden during the period immediately following the
PHE. We are concerned about issues raised by commenters related to
payment stability in the post-PHE period, as care delivery will
potentially be transitioning between virtual, hybrid, and in-person
models. As such, we are finalizing that we will continue to allow for
payment be made for Medicare telehealth services at the place of
service for telehealth services that ordinarily would have been paid
under the PFS, if the services were furnished in-person, through the
latter of the end of the of CY 2023 or the end of the calendar year in
which the PHE ends. For those services furnished in a facility as an
originating site, POS 02 may be used, and the corresponding facility
fee can be billed, per pre-PHE policy, beginning the 152nd day after
the end of the PHE.
Comment: Some commenters expressed concern that our proposals to
transition to the use of new modifiers would create confusion and
administrative burden, without sufficient time to allow for the
sufficient training education of clinical and administrative staff to
implement new billing practices. Others supported immediate
implementation.
Response: We appreciate commenters' feedback. We believe that the
use of these modifiers following the end of the PHE, when implemented,
will enable practitioners to better report (and allow CMS to better
understand) how they practice and when certain services are furnished
via telehealth. We do not agree that these modifiers/codes would cause
confusion; rather, they will provide clarity. Moreover, education
regarding these modifiers/codes will be made available, as necessary.
After consideration of public comments, we are finalizing our
proposals, with some modifications regarding the use of telehealth
modifiers/codes and the payment rates. Practitioners will continue to
bill with modifier 95 along with the POS code corresponding to where
the service would have been furnished in-person through the later of
the end of the year in which the PHE ends or CY 2023. As stated
earlier, for those services furnished in a facility as an originating
site, POS 02 may be used, and the corresponding facility fee can be
billed, per pre-PHE policy, beginning the 152nd day after the end of
the PHE.
Additionally, effective on and after January 1, 2023, CPT modifier
``93'' can be appended to claim lines, as appropriate, for services
furnished using audio-only communications technology in accordance with
our regulation at Sec. 410.78(a)(3). All providers, including RHCs,
FQHCs, and OTPs must append Medicare modifier ``FQ'' (Medicare
telehealth service was furnished using audio-only communication
technology) for allowable audio-only services furnished in those
settings. However,
[[Page 69467]]
consistent with our proposal for audio-only services furnished under
the PFS, we are also finalizing to require all providers including
RHCs, FQHCs, and OTPs to use modifier ``93'' when billing for eligible
mental health services furnished via audio-only telecommunications
technology. Providers have the option to use the ``FQ'' or the 93''
modifiers or both where appropriate and true, since they are identical
in meaning.
Supervising practitioners continue to be required to append the
``FR'' modifier on any applicable telehealth claim when they provide
direct supervision for a service using virtual presence through real-
time, audio and video telecommunications technology.
In response to the issues raised by commenters related to payment
stability in the post-PHE period, we are reiterating that we are
finalizing that, for Medicare telehealth services, we will continue to
maintain payment at the POS had the service been furnished in-person,
and this will allow payments to continue to be made at the non-
facility-based rate for Medicare telehealth services through the latter
of the end of CY 2023 or the end of the calendar year in which the PHE
ends.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
Under Medicare Part B, certain types of services, including
diagnostic tests, services incident to physicians' or practitioners'
professional services, and other services, are required to be furnished
under specific minimum levels of supervision by a physician or
practitioner.
For professional services furnished incident to the services of the
billing physician or practitioner (see Sec. 410.26) and many
diagnostic tests (see Sec. 410.32), direct supervision is required.
Additionally, for pulmonary rehabilitation services (see Sec. 410.47)
and for cardiac rehabilitation and intensive cardiac rehabilitation
services (see Sec. 410.49), direct supervision of a physician is
required (see also Sec. 410.27(a)(1)(iv)(D) for hospital outpatient
services).Outside the circumstances of the PHE, direct supervision
requires the immediate availability of the supervising physician or
other practitioner, but the professional need not be present in the
same room during the service. We have established this ``immediate
availability'' requirement to mean in-person, physical, not virtual,
availability (please see the April 6, 2020 IFC (85 FR 19245) and the CY
2022 PFS final rule (86 FR 65062)).
Through the March 31, 2020 COVID-19 IFC, we changed the definition
of ``direct supervision'' during the PHE for COVID-19 (85 FR 19245
through 19246) as it pertains to supervision of diagnostic tests,
physicians' services, and some hospital outpatient services, to allow
the supervising professional to be immediately available through
virtual presence using real-time audio/video technology, instead of
requiring their physical presence. In the CY 2021 PFS final rule (85 FR
84538 through 84540), we finalized continuation of this policy through
the later of the end of the calendar year in which the PHE for COVID-19
ends or December 31, 2021. In the March 31, 2020 IFC (85 FR 19246) and
in our CY 2022 PFS final rule (see 85 FR 65063), we also noted that the
temporary exception to allow immediate availability for direct
supervision through virtual presence facilitates the provision of
telehealth services by clinical staff of physicians and other
practitioners' incident to their own professional services. This is
especially relevant for services such as physical therapy, occupational
therapy, and speech language pathology services, since those
practitioners can only bill Medicare for telehealth services under
Medicare telehealth waivers that are effective only during the PHE for
COVID-19 (based on the emergency waiver authority established in
section 1135(b)(8) of the Act), and for 151 days after the final day of
the PHE for COVID-19, as specified by provisions of the CAA, 2022. We
noted that sections 1834(m)(4)(D) and (E) of the Act specify the types
of clinicians who may furnish and bill for Medicare telehealth
services. Outside of the PHE and the 151-day period after the PHE ends,
such clinicians include only physicians as defined in section 1861(r)
of the Act and practitioners described in section 1842(b)(18)(C) of the
Act. We remind readers that after December 31 of the year in which the
PHE ends, the pre-PHE rules for direct supervision at Sec.
410.32(b)(3)(ii) would apply. As noted in the CY 2022 PFS final rule
(86 FR 65062), this means the temporary exception to allow immediate
availability for direct supervision through virtual presence, which
facilitates the provision of telehealth services by clinical staff of
physicians and other practitioners incident to their professional
services, will no longer apply. As such, after the end of the calendar
year in which the PHE ends, Medicare telehealth services can no longer
be performed by clinical staff incident to the professional services of
the billing physician or practitioner who directly supervises the
service through their virtual presence.
While we did not propose to make the temporary exception to allow
immediate availability for direct supervision through virtual presence
permanent, as with last year's rulemaking (86 FR 39149 through 50), we
continue to solicit information on whether the flexibility to meet the
immediate availability requirement for direct supervision through the
use of real-time, audio/video technology should potentially be made
permanent. We also solicited comment regarding the possibility of
permanently allowing immediate availability for direct supervision
through virtual presence using real-time, audio/video technology for
only a subset of services, as we recognize that it may be inappropriate
to allow direct supervision without physical presence for some services
due to potential concerns over patient safety. As discussed in last
year's final rule (86 FR 65063), and based on gaps in the currently
available evidence, we are in need of more information as we consider
whether to make permanent a temporary exception to our direct
supervision policy.
We received public comments on expiration of PHE flexibilities for
direct supervision requirements. The following is a summary of the
comments we received and our responses.
Comment: Commenters offered a variety of perspectives and
suggestions for possible ways that CMS could modify the direct
supervision requirements. Many commenters that recommended a permanent
change to direct supervision rules supported their feedback by raising
issues such as health care workforce shortages and concern with
clinician burnout that would possibly occur from implementing the pre-
PHE direct supervision requirements. Others noted that certain NPPs,
such as PAs, and advanced practice nurse practitioners are authorized
under state law statutory requirements in many states to practice
independently under virtual supervision of a physician. Still others
based their recommendations that we establish a permanent virtual
direct supervision on a specialty-level or service-level analysis. For
example, commenters identified a certain specialty or family of codes
that would be typically low-risk for patient safety issues, and
indicated that those specialties or services would be appropriate
candidates for a permanent virtual direct supervision policy. Some
[[Page 69468]]
commenters mentioned that virtual direct supervision may also reduce
the burden and overhead costs associated with enrolling their
practitioners through multiple MAC jurisdictions.
Response: We continue to gather information on this topic, and we
appreciate the information provided by commenters. We remind readers
that, as described earlier in this section, our current temporary
policy to permit immediate availability for purposes of direct
supervision through the virtual presence of the billing clinician was
adopted to address the circumstances of the PHE for COVID-19. We
believe allowing additional time to collect information and evidence
for direct supervision through virtual presence will help us to better
understand the potential circumstances in which this flexibility could
be appropriate permanently, outside of the PHE for COVID-19. We realize
that direct supervision through virtual presence is probably not
something that we would have contemplated without our experience in
implementing this policy during the PHE, and we hope to learn more
about this in the near future. We also note that the Secretary renewed
the PHE for the COVID-19 pandemic for a 90-day period beginning on
October 13, 2022,\9\ which means that the PHE would expire on January
11, 2023, absent any further action by the Secretary regarding the PHE
for COVID-19. As such, we expect to continue to permit direct
supervision through virtual presence through at least the end of CY
2023 under our previously finalized policy which, as specified in Sec.
410.32(a)(3)(ii), continues through the end of the calendar year in
which the PHE ends. With that said, CMS will consider the comments
received from the proposed rule for potential future PFS rulemaking.
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\9\ https://aspr.hhs.gov/legal/PHE/Pages/covid19-13Oct2022.aspx.
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3. Telehealth Originating Site Facility Fee Update
Section 1834(m)(2)(B) of the Act established the initial Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00,
and specifies that for telehealth services furnished on or after
January 1 of each subsequent calendar year, the telehealth originating
site facility fee is increased by the percentage increase in the
Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the
Act. The final MEI increase for CY 2023 is 3.8 percent and is based on
the most recent historical percentage increase of the 2017-based MEI
for the second quarter of 2022.
Therefore, for CY 2023, the final payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is $28.64. The
Medicare telehealth originating site facility fee and the MEI increase
by the applicable time period are shown in Table 15.
[GRAPHIC] [TIFF OMITTED] TR18NO22.019
[[Page 69469]]
E. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the
5-year review process, revisions in RVUs were proposed and finalized
via rulemaking. In addition to the 5-year reviews, beginning with CY
2009, CMS and the RUC identified a number of potentially misvalued
codes each year using various identification screens, as discussed in
section II.C. of this final rule, Potentially Misvalued Services under
the PFS. Historically, when we received RUC recommendations, our
process had been to establish interim final RVUs for the potentially
misvalued codes, new codes, and any other codes for which there were
coding changes in the final rule with comment period for a year. Then,
during the 60-day period following the publication of the final rule
with comment period, we solicit public comment about those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we paid for services based upon the
interim final values established in the final rule. In the final rule
with comment period for the subsequent year, we consider and responded
to public comments received on the interim final values, and typically
make any appropriate adjustments and finalize those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we established interim final
values in the CY 2016 PFS final rule with comment period (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), and re-proposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
Federal Government as part of our process for establishing valuations.
Where we concur that the RUC's recommendations, or recommendations from
other commenters, are reasonable and appropriate and are consistent
with the time and intensity paradigm of physician work, we proposed
those values as recommended. Additionally, we continually engage with
interested parties, including the RUC, with regard to our approach for
accurately valuing codes, and as we prioritize our obligation to value
new, revised, and potentially misvalued codes. We continue to welcome
feedback from all interested parties regarding valuation of services
for consideration through our rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conduct a review that
includes the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the Federal
Government, as well as Medicare claims data. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we use in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could include the CPT codes that make up the bundled code
and the inputs associated with those codes. We use the building block
methodology to construct, or deconstruct, the work RVU for a CPT code
based on component pieces of the code. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. Section 1848(c)(1)(A) of the
Act specifically defines the work component as the resources that
reflect time and intensity in furnishing the service. Also, the
published literature on valuing work has recognized the key role of
time in overall work. For particular codes, we refine the work RVUs in
direct proportion to the changes in the best information regarding the
time resources involved in furnishing
[[Page 69470]]
particular services, either considering the total time or the
intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an E/M service, we believe that there is overlap between the two
services in some of the activities furnished during the preservice
evaluation and postservice time. Our longstanding adjustments have
reflected a broad assumption that at least one-third of the work time
in both the preservice evaluation and postservice period is duplicative
of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. We also include a summary of interested
party reactions to our approach when available. We noted in past
rulemaking that many commenters and interested parties have expressed
concerns over the years with our reviews of and updates to work RVUs
based on changes in the best available information regarding the time
resources involved in furnishing individual services. We have been
particularly concerned with the RUC's and various specialty societies'
objections to our approach given the significance of their
recommendations to our process for valuing services and since much of
the information we use to update the RVUs is derived from their survey
process. We are obligated under the statute to consider both time and
intensity in establishing work RVUs for PFS services. As explained in
the CY 2016 PFS final rule with comment period (80 FR 70933), we
recognize that adjusting work RVUs for changes in time is not always a
straightforward process, so we have applied various methodologies to
identify several potential work values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we sometimes use the relationship
between the ``old time'' values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we believe that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC's recommendation has appeared to
disregard or dismiss the changes in time, without a persuasive
explanation of why such a change should not be accounted for in the
overall work of the service, then we have generally used one of the
aforementioned methodologies to identify potential work RVUs, including
the methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several interested parties, including the RUC, have expressed
general objections to our use of these methodologies to adjust for
reductions in time, suggesting that our adjustments to the RUC-
recommended work RVUs are inappropriate. Other interested parties have
expressed general concerns with our refinements to RUC-recommended
values. In the CY 2017 PFS proposed rule (81 FR 46162), we requested
comments regarding potential alternatives to making adjustments that
would recognize overall estimates of work in the context of changes in
the resource of time for particular services; however, we did not
receive any specific potential alternatives. In the CY 2017 PFS final
rule (81 FR 80272 through 80277), we responded in detail to several
comments that we received regarding our approach to RUC-recommended
work times and RVUs. As described earlier in this section, crosswalks
to key reference or similar codes are one of the many methodological
approaches we have employed to identify potential values that reconcile
the RUC-recommend work RVUs with the recommended time values when the
RUC-recommended
[[Page 69471]]
work RVUs did not appear to account for significant changes in time.
We received several comments regarding our methodologies for work
valuation in response to the CY 2023 PFS proposed rule and those
comments are summarized below.
Comment: Several commenters disagreed with our reference to older
work time sources, and stated that their use led to the proposal of
work RVUs based on flawed assumptions. Commenters stated that codes
with ``CMS/Other'' or ``Harvard'' work time sources, used in the
original valuation of certain older services, were not surveyed, and
therefore, were not resource-based. Commenters also stated that it was
invalid to draw comparisons between the current work times and work
RVUs of these services to the newly surveyed work time and work RVUs as
recommended by the RUC.
Response: We agree that it is important to use the recent data
available regarding work times, and we note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also believe that our operating assumption regarding
the validity of the existing values as a point of comparison is
critical to the integrity of the relative value system as currently
constructed. The work times currently associated with codes play a very
important role in PFS ratesetting, both as points of comparison in
establishing work RVUs and in the allocation of indirect PE RVUs by
specialty. If we were to operate under the assumption that previously
recommended work times had been routinely overestimated, this would
undermine the relativity of the work RVUs on the PFS in general, in
light of the fact that codes are often valued based on comparisons to
other codes with similar work times. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, which is why we apply various methodologies
to identify several potential work values for individual codes.
However, we reiterate that we believe it would be irresponsible to
ignore changes in time based on the best data available, and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
Comment: Several commenters disagreed with the use of time ratio
methodologies for work valuation. Commenters stated that this use of
time ratios is not a valid methodology for valuation of physician
services. Commenters stated that treating all components of physician
time (preservice, intraservice, postservice and post-operative visits)
as having identical intensity is incorrect, and inconsistently applying
it to only certain services under review creates inherent payment
disparities in a payment system, which is based on relative valuation.
Commenters stated that in many scenarios, CMS selects an arbitrary
combination of inputs to apply rather than seeking a valid clinically
relevant relationship that would preserve relativity. Commenters
suggested that CMS determine the work valuation for each code based not
only on surveyed work times, but also the intensity and complexity of
the service and relativity to other similar services, rather than
basing the work value entirely on time. Commenters recommended that CMS
embrace the clinical input from practicing physicians when valid
surveys were conducted and provide a clinical rationale when proposing
crosswalks for valuation of services.
Response: We disagree and continue to believe that the use of time
ratios is one of several appropriate methods for identifying potential
work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for survey information that suggests the amount of time
involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. When our review of recommended
values reveals that changes in time are not accounted for in a RUC-
recommended work RVU, the obligation to account for that change when
establishing proposed and final work RVUs remains.
We recognize that it would not be appropriate to develop work RVUs
solely based on time given that intensity is also an element of work,
but in applying the time ratios, we are using derived intensity
measures based on current work RVUs for individual procedures. We
clarify again that we do not treat all components of physician time as
having identical intensity. If we were to disregard intensity
altogether, the work RVUs for all services would be developed based
solely on time values and that is not the case, as indicated by the
many services that share the same time values but have different work
RVUs. For example, among the codes reviewed in this CY 2023 PFS final
rule, CPT codes 22632 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; each additional
interspace), 63035 (Laminotomy (hemilaminectomy), with decompression of
nerve root(s), including partial facetectomy, foraminotomy and/or
excision of herniated intervertebral disc; each additional interspace,
cervical or lumbar), 93655 (Intracardiac catheter ablation of a
discrete mechanism of arrhythmia which is distinct from the primary
ablated mechanism, including repeat diagnostic maneuvers, to treat a
spontaneous or induced arrhythmia), and 99285 (Emergency department
visit for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making) all share the same intraservice and total work
time of 60 minutes. However, these codes had very different proposed
work RVUs of 5.22 and 3.86 and 5.50 and 4.00, respectively. These
examples demonstrate that we do not value services purely based on work
time; instead, we incorporate time as one of multiple different factors
in our review process. Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277).
We also clarify for the commenters that our review process is not
arbitrary in nature. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the
[[Page 69472]]
RUC, the HCPAC, and other public commenters, medical literature, and
comparative databases, as well as a comparison with other codes within
the PFS, consultation with other physicians and health care
professionals within CMS and the Federal Government, as well as
Medicare claims data. We also assess the methodology and data used to
develop the recommendations submitted to us by the RUC and other public
commenters and the rationale for the recommendations. In the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329), we
discussed a variety of methodologies and approaches used to develop
work RVUs, including survey data, building blocks, crosswalks to key
reference or similar codes, and magnitude estimation (see the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329) for more
information).
With regard to the commenter's concerns regarding clinically
relevant relationships, we emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
Comment: Several commenters did not agree with CMS valuing codes
based on work RVU increments. Commenters stated that this methodology
for valuing codes inaccurately treats all components of the physician
time as having identical intensity and would lead to incorrect work
valuations. Commenters stated that CMS should carefully consider the
clinical information justifying the changes in physician work intensity
provided by the RUC and other interested parties.
Response: We believe that using the incremental difference between
the work RVUs of codes is a valid methodology for setting values,
especially when valuing services within a family of revised codes where
it is important to maintain appropriate intra-family relativity.
Historically, we have frequently used an incremental methodology in
which we value a code based upon the incremental work RVU difference
between the code and another code or another family of codes. We note
that the RUC has also used the same incremental methodology on occasion
when it was unable to produce valid survey data for a service. We have
no evidence to suggest that the use of an incremental difference
between the work RVUs of codes conflicts with the statute's definition
of the work component as the resources in time and intensity required
in furnishing the service. We do consider clinical information
associated with physician work intensity provided by the RUC and other
interested parties as part of our review process, although we remind
readers again that we do not believe that it is necessary for codes to
share the same site of service, patient population, or utilization
level in order to serve as an appropriate crosswalk.
Comment: Several commenters stated that they were concerned about
CMS' lack of consideration for compelling evidence that services have
changed. Commenters stated that CMS appeared to dismiss the fact that
services may change due to technological advances, changes in the
patient population, shifts in the specialty of physicians providing
services or changes in the physician work or intensity required to
perform services. Commenters stated that CMS' failure to discuss
compelling evidence does not reflect the long history of reviewing
potentially misvalued codes, first through the statutorily mandated 5-
year review processes and more recently from continuous annual reviews.
Commenters stated that CMS has discussed compelling evidence in
rulemaking since the inception of the RBRVS and has informed public
commenters to consider compelling evidence to identify potentially
misvalued codes. Commenters requested that CMS address the compelling
evidence submitted with the RUC recommendations when the agency does
not accept the RUC's recommended work RVUs.
Response: The concept of compelling evidence was developed by the
RUC as part of its work RVU review process for individual codes. The
RUC determines whether there is compelling evidence to justify an
increase in valuation. The RUC's compelling evidence criteria include
documented changes in physician work, an anomalous relationship between
the code and multiple key reference services, evidence that technology
has changed physician work, analysis of other data on time and effort
measures, and evidence that incorrect assumptions were made in the
previous valuation of the service. While we appreciate the submission
of this additional information for review, we emphasize that the RUC
developed the concept of compelling evidence for its own review
process; an evaluation of ``compelling evidence,'' at least as
conceptualized by the RUC, is not part of our review process, as our
focus is the time and intensity of services, in accordance with the
statute. With that said, we do consider changes in technology, patient
population, and other compelling evidence criteria, as such evidence
may affect the time and intensity of a service under review. For
example, new technology may cause a service to become easier or more
difficult to perform, with corresponding effects on the time and
intensity of the service. However, we are under no obligation to adopt
the same review process or compelling evidence criteria as the RUC. We
instead focus on evaluating and addressing the time and intensity of
services when reviewing potentially misvalued codes because section
1848(c)(1)(A) of the Act specifically defines the work component as the
resources that reflect time and intensity in furnishing the service.
Comment: Several commenters raised the issue of the refinement
panel which was last reformed in CY 2016. Commenters stated that the
refinement panel was not obsolete and was not mutually exclusive with
the change to include all proposed valuations in each year's proposed
rule. Commenters stated that for 2 decades, the refinement panel
process was considered by interested parties to be an appeals process
and its elimination discontinued CMS' reliance on outside interested
parties to provide accountability through a transparent appeals
process. Commenters requested that CMS consider these issues and create
an objective, transparent and consistently applied formal appeals
process that would be open to any commenting organization.
Response: We did not propose any changes to the refinement panel
for CY 2023. As we stated in the CY 2016 PFS final rule (80 FR 70917
and 70918), the refinement panel was established to assist us in
reviewing the public comments on CPT codes with interim final work RVUs
and in balancing the interests of the specialty societies who commented
on the work RVUs with the budgetary and redistributive effects that
could occur if we accepted extensive increases in work RVUs across a
broad range of services. When developing the CY 2016 proposed rule, and
continuing to the present, we did not believe that the refinement panel
had generally served as the kind of ``appeals'' or reconsideration
process that some interested parties envisioned in their comments. We
also believe that the refinement panel was not achieving its intended
purpose. Rather than providing us with additional information, balanced
across specialty interests, to assist us in establishing work RVUs, the
refinement panel
[[Page 69473]]
process generally served to rehash the issues raised and information
already discussed at the RUC meetings and considered by CMS. In
contrast to the prior process of establishing interim final values and
using a refinement panel process that generally was not observed by
members of the public, we continue to believe that the current process
of proposing the majority of code values in a proposed rule, giving the
public the opportunity to comment on those proposed values, and then
finalizing those values in a final rule offers greater transparency and
accountability.
We also note that we did not finalize our proposal to eliminate the
refinement panel completely in CY 2016. We retain the ability to
convene refinement panels for codes with interim final values under
circumstances where additional input provided by the panel is likely to
add value as a supplement to notice and comment rulemaking. We also
remind interested parties that we have established an annual process
for the public nomination of potentially misvalued codes. This process,
described in the CY 2012 PFS final rule (76 FR 73058), provides an
annual means for those who believe that values for individual services
are inaccurate and should be readdressed through notice and comment
rulemaking to bring those codes to our attention.
In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified that terms ``reference services'', ``key reference
services'', and ``crosswalks'' as described by the commenters are part
of the RUC's process for code valuation. These are not terms that we
created, and we do not agree that we necessarily must employ them in
the identical fashion for the purposes of discussing our valuation of
individual services that come up for review. However, in the interest
of minimizing confusion and providing clear language to facilitate
feedback from interested parties, we will seek to limit the use of the
term, ``crosswalk,'' to those cases where we are making a comparison to
a CPT code with the identical work RVU. We also occasionally make use
of a ``bracket'' for code valuation. A ``bracket'' refers to when a
work RVU falls between the values of two CPT codes, one at a higher
work RVU and one at a lower work RVU.
We look forward to continuing to engage with interested parties and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 16 contains a list of codes and
descriptors for which we proposed work RVUs; this includes all codes
for which we received RUC recommendations by February 10, 2022. The
finalized work RVUs, work time and other payment information for all CY
2023 payable codes are available on the CMS website under downloads for
the CY 2023 PFS final rule at (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the Federal Government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 18 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of
PE RVUs, we address certain proposed refinements that would be common
across codes. We also address the refinements to particular codes that
we are finalizing in section II.B. of this rule. We note that for each
refinement of the RUC-recommended direct PE inputs that we are
finalizing, we indicate the potential impact on direct costs for that
service. We also note that, on average, in any case where the impact on
the direct cost for a particular refinement is $0.35 or less, the
refinement has no impact on the PE RVUs. This calculation considers
both the impact on the direct portion of the PE RVU, as well as the
impact on the indirect allocator for the average service. We also noted
that many of the refinements listed in Table 17 result in changes under
the $0.35 threshold and would be unlikely to result in a change to the
RVUs.
We note that the final direct PE inputs for CY 2023 are displayed
in the CY 2023 direct PE input files, available on the CMS website
under the downloads for the CY 2023 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the final CY 2023 PE RVUs
as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general
[[Page 69474]]
guidelines regarding appropriate equipment time inputs. We appreciate
the RUC's willingness to provide us with these additional inputs as
part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time will also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also noted that we believe these same assumptions will
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question will be available if the
room is not being occupied by a particular patient. For additional
information, we referred readers to our discussion of these issues in
the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this final rule, Determination
of PE RVUs, for more information regarding the collaborative work of
CMS and the RUC in improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2023, we received invoices for several new supply and
equipment items. Tables 19 and 20 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final rule, Determination of Practice Expense Relative
Value Units, we encourage interested parties to review the prices
associated with these new and existing items to determine whether these
prices appear to be accurate. Where prices appear inaccurate, we
encourage interested parties to submit invoices or other information to
improve the accuracy of pricing for these items in the direct PE
database by February 10th of the following year for consideration in
future rulemaking, similar to our process for consideration of RUC
recommendations.
We remind interested parties that due to the relativity inherent in
the development of RVUs, reductions in existing prices for any items in
the direct PE database increase the pool of direct PE RVUs available to
all other PFS services. Tables 19 and 20 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that interested parties will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that interested
parties are more likely to have better pricing information for items
used more frequently. A single invoice may not be reflective of typical
costs and we encourage interested parties to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we include the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
[[Page 69475]]
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the list of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are
subject to the OPPS cap; are displayed in the public use files for the
PFS proposed and final rules for each year. The public use files for CY
2023 are available on the CMS website under downloads for the CY 2023
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule with comment period (78 FR 74261 through
74263).
Effective January 1, 2007, section 5102(b)(1) of the Deficit
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section
1848(b)(4) of the Act to require that, for imaging services, if--(i)
The technical component (TC) (including the TC portion of a global fee)
of the service established for a year under the fee schedule without
application of the geographic adjustment factor, exceeds (ii) The
Medicare OPD fee schedule amount established under the prospective
payment system (PPS) for hospital outpatient (HOPD) services under
section 1833(t)(3)(D) of the Act for such service for such year,
determined without regard to geographic adjustment under paragraph
(t)(2)(D) of such section, the Secretary shall substitute the amount
described in clause (ii), adjusted by the geographic adjustment factor
[under the PFS], for the fee schedule amount for such TC for such year.
As required by the section 1848(b)(4)(A) of the Act, for imaging
services furnished on or after January 1, 2007, we cap the TC of the
PFS payment amount for the year (prior to geographic adjustment) by the
Outpatient Prospective Payment System (OPPS) payment amount for the
service (prior to geographic adjustment). We then apply the PFS
geographic adjustment to the capped payment amount. Section
1848(b)(4)(B) of the Act defines imaging services as imaging and
computer-assisted imaging services, including X-ray, ultrasound
(including echocardiography), nuclear medicine (including PET),
magnetic resonance imaging (MRI), computed tomography (CT), and
fluoroscopy, but excluding diagnostic and screening mammography. For
more information regarding the history of the cap on the TC of the PFS
payment amount under the DRA (the ``OPPS cap''), we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69659 through
69662).
For CY 2023, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined above
for purposes of this cap. Beginning for CY 2023, we proposed to include
the following services on the list of codes to which the OPPS cap
applies: CPT codes 0493T (Contact near-infrared spectroscopy studies of
lower extremity wounds (e.g., for oxyhemoglobin measurement)), 0640T
(Noncontact near-infrared spectroscopy studies of flap or wound (e.g.,
for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue
oxygenation [StO2]); image acquisition, interpretation and report, each
flap or wound), 0641T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); image acquisition only, each
flap or wound), 0642T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); interpretation and report
only, each flap or wound), 0651T (Magnetically controlled capsule
endoscopy, esophagus through stomach, including intraprocedural
positioning of capsule, with interpretation and report), 0658T
(Electrical impedance spectroscopy of 1 or more skin lesions for
automated melanoma risk score), 0689T (Quantitative ultrasound tissue
characterization (non-elastographic), including interpretation and
report, obtained without diagnostic ultrasound examination of the same
anatomy (e.g., organ, gland, tissue, target structure)), 0690T
(Quantitative ultrasound tissue characterization (non-elastographic),
including interpretation and report, obtained with diagnostic
ultrasound examination of the same anatomy (e.g., organ, gland, tissue,
target structure) (List separately in addition to code for primary
procedure)), 0694T (3-dimensional volumetric imaging and reconstruction
of breast or axillary lymph node tissue, each excised specimen, 3-
dimensional automatic specimen reorientation, interpretation and
report, real-time intraoperative), 0700T (Molecular fluorescent imaging
of suspicious nevus; first lesion), 0701T (Molecular fluorescent
imaging of suspicious nevus; each additional lesion (List separately in
addition to code for primary procedure)), and 76883 (Ultrasound,
nerve(s) and accompanying structures throughout their entire anatomic
course in one extremity, comprehensive, including real-time cine
imaging with image documentation, per extremity). As CPT codes 0493T,
0642T, 0651T, 0658T, and 76883 are not within the statutory scope of
services to which the OPPS cap applies, as they cannot be split into
professional and technical components, or they only describe the
professional component (PC), we thus proposed to add these codes to the
OPPS DRA caps list in error. Therefore, we are not finalizing our
proposal to add them to the list of services to which the OPPS cap
applies. We believe that the remaining codes, CPT codes 0640T, 0641T,
0689T, 0690T, 0694T, 0700T, and 0701T, meet the definition of imaging
services under section 1848(b)(4)(B of the Act, and thus, should be
subject to the OPPS cap. Therefore, we are finalizing our proposal to
add CPT codes 0640T, 0641T, 0689T, 0690T, 0694T, 0700T, and 0701T to
the list of services to which the OPPS cap applies, and we are not
finalizing our proposal to add CPT codes 0493T, 0642T, 0651T, 0658T,
and 76883 to the OPPS cap list.
4. Valuation of Specific Codes for CY 2023
(1) Anterior Abdominal Hernia Repair (CPT Codes 15778, 49591, 49592,
49593, 49594, 49595, 49596, 49613, 49614, 49615, 49616, 49617, 49618,
49621, 49622, and 49623)
In April 2021, the RUC reviewed an existing code that describes
hernia repair, CPT code 49565 (Repair recurrent incisional or ventral
hernia; reducible). CPT code 49565 was identified as being performed
less than 50 percent of the time in the inpatient setting and being
primarily performed in the outpatient setting. Interested
[[Page 69476]]
parties requested referral to CPT to update the code's descriptor. In
response to the disparate site of service and request to update the
code's descriptor, CPT created new codes with 000-day global periods to
describe this type of service. The codes within this family are
differentiated by 3 characteristics: whether the hernia is initial or
recurrent, whether it is reducible or strangulated, and the total
length of the hernia. CPT also created two new codes that describe
parastomal hernia repair and an add-on code for removal of mesh.
The RUC recommendations differentiate the post-operative periods
for the codes within this family by whether there is a same-day
discharge, overnight stay with a visit on the same date, or whether the
patient is admitted to the hospital. We disagree with many of the RUC-
recommended work RVUs for the codes within this family that have a
post-operative overnight stay built into their valuation. More
specifically, we disagree with the RUC-recommended work RVUs for such
codes because the RUC did not completely apply the 23-hour policy
calculation (finalized in the CY 2011 PFS final rule (75 FR 73226)) in
formulating its recommendations. Additionally, we disagree with the
RUC-recommended work RVUs for the CPT codes in this family for which
the RUC considered the patient to be admitted during the post-operative
period because the RUC did not apply the 23-hour policy when
formulating its recommendations.
As we noted in the CY 2011 PFS final rule (75 FR 73226), the work
RVUs for services that are typically performed in the outpatient
setting and require a hospital stay of less than 24 hours may in some
cases involve multiple overnight stays while the patient is still
considered to be an outpatient for purposes of Medicare payment.
Because such services are typically furnished in the outpatient
setting, they should not be valued to include inpatient post-operative
E/M visits. The level of discharge day management services included in
the valuation of such services should similarly not reflect an
inpatient discharge and should therefore be reduced. And finally, as
discussed in CY 2011 rulemaking, the intraservice time from the
inpatient level E/M postoperative visit should be reallocated to the
immediate postservice time of the service. The 23-hour policy
calculation, when fully applied to the calculation of a work RVU, is
used to reduce the value of discharge day management services, remove
the inpatient E/M visits, and reallocate the intraservice time to the
immediate post-service period. See the CY 2011 PFS final rule (75 FR
73226) for additional in-depth explanation of the 23-hour policy.
For the codes with an overnight stay and an E/M visit on the same
date built into their valuation, we believe the RUC only partially
applied the 23-hour policy when it applied the policy to the immediate
post service times, but not to the calculation of the work RVUs.
Instead, we believe the 23-hour policy should be fully applied to the
codes in this family that describe outpatient services for which there
is an overnight stay during the post-operative period, regardless of
the number of nights that a patient stays in the hospital. The services
to which the 23-hour policy is usually applied would typically involve
a patient stay in a hospital for less than 24 hours, which often means
the patient may stay overnight in the hospital. On occasion, the
patient may stay in the hospital longer than a single night; however,
in both cases (one night or more than one night), the patient is
considered to be a hospital outpatient, not an inpatient, for Medicare
purposes. In short, we do not believe that the work that is typically
associated with an inpatient service should be included in the work
RVUs for the outpatient services to which the 23-hour policy applies.
The RUC recommended a work RVU of 8.0 for CPT code 15778
(Implantation of absorbable mesh or other prosthesis for delayed
closure of defect(s) (ie, external genitalia, perineum, abdominal wall)
due to soft tissue infection or trauma). CPT code 15778 was surveyed
with having one subsequent hospital visit, CPT code 99232 (subsequent
hospital care/day 25 minutes) and 25 minutes of immediate post service
time. For purposes of calculating the recommended work RVU of 8.0, the
RUC considered CPT code 15778 to describe an inpatient service, while
we consider CPT code 15778 to describe an outpatient service for
purposes of Medicare billing. As noted above, we do not believe that
work that is typically associated with an inpatient service should be
included in the work RVUs for the outpatient services to which the 23-
hour policy applies. Therefore, the valuation for this code should not
include inpatient work in the post-operative period. See the CY 2022
PFS final rule (86 FR 65090) for further discussion on the 23-hour
policy as it relates to outpatient billing. We believe the 23-hour
policy should be fully applied to CPT code 15778, and we disagree with
the RUC-recommended work RVU of 8.0.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we instead proposed a work
RVU of 7.05 for CPT code 15778 and a reallocation of the time
associated with the intra-service portion of the inpatient hospital
visit to the immediate postservice time of CPT code 15778.
The steps for the 23-hour policy calculation are as follows:
Step (1): CPT code 15778 does not have a hospital
discharge day management service; therefore, we will skip this step*.
Step (2): 8.0-1.39** = 6.61.
Step (3): 6.61 + (20 minutes x 0.0224)*** = 7.05 RVUs.
*Value associated with \1/2\ hospital discharge day management
service
**Value associated with an inpatient hospital visit, CPT code
99232.
***Value associated with the reallocated intraservice time
multiplied by the postservice intensity of the 23-hour stay code.
The following CPT codes have a post-operative period that is
considered an overnight stay with a visit on the same date: CPT codes
49592 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
incarcerated or strangulated), 49593 (Repair of anterior abdominal
hernia(s) (ie, epigastric, incisional, ventral, umbilical, spigelian),
any approach (ie, open, laparoscopic, robotic), initial, including
placement of mesh or other prosthesis, when performed, total length of
defect(s); 3 cm to 10 cm, reducible), 49594 (Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), initial,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
49595 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); greater than 10
cm, reducible), 49614 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s);
less than 3 cm, incarcerated or strangulated), and 49615 (Repair of
anterior abdominal hernia(s) (ie,
[[Page 69477]]
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s); 3
cm to 10 cm, reducible). The RUC recommended a work RVU of 9.0 for CPT
code 49592, 10.80 for CPT code 49593, 14.0 for CPT code 495944, 14.88
for CPT code 49595, 10.79 for CPT code 49614, and 12.0 for CPT code
496159. CPT codes 49592, 495933, 49614, and 49615 were surveyed with
one subsequent inpatient hospital visit at a level of CPT code 99231
(subsequent hospital care/day 15 minutes). The RUC applied the 10
minutes of intraservice time from CPT code 99231 to the immediate
postservice time of these codes, resulting in a total immediate
postservice time of 30 minutes for these codes. CPT codes 49594 and
49595 were surveyed with a subsequent inpatient hospital visit at a
level of CPT code 99232. The RUC applied the 20 minutes of intraservice
time from CPT code 99232 to the immediate postservice time of both
codes, resulting in a total immediate postservice time of 40 minutes.
Much like our concerns regarding the RUC-recommended work RVU for
CPT code 15778, we do not believe that the RUC fully applied the 23-
hour policy calculation when calculating the work RVUs for these codes
and we disagree with the RUC-recommended RVUs. While the RUC removed
the 99231 and 99232 inpatient visits included in the post-operative
period for these codes, the RUC did not subtract the values of these
visits from the work RVUs before making their work RVU recommendations.
In the CY 2011 PFS final rule (75 FR 73226), we stated that we do not
believe that the post-procedure hospital visits for outpatient services
should be at the inpatient level since the typical case is an
outpatient who would be ready to be discharged from the hospital in 23
hours or less. However, we agree with the RUC that the intra-service
time of the inpatient hospital visit may be included in the valuation
for 23-hour stay codes. Therefore, we believe that step 2 of the 23-
hour hour policy calculation, which involves deducting the RVUs of the
inpatient hospital visits from the starting work RVU value and
subsequently reallocating the time associated with the intra-service
portion of the inpatient hospital visits to the immediate postservice
time of the 23-hour stay code, should be fully applied when calculating
the work RVUs for CPT codes 49592, 49593, 49594, 49595, 49614, and
49615.
Using the 23-hour policy calculation described above and in the CY
2011 PFS final rule, we proposed work RVUs of 8.46 for CPT code 49592,
10.26 for CPT code 49593, 13.46 for CPT code 49594, 13.94 for CPT code
49595, 10.25 for CPT code 49614, and 11.46 for CPT code 49615.
The following CPT codes have a post-operative period that the RUC
considers to be admitted to a hospital: CPT code 49596 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49616 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s); 3
cm to 10 cm, incarcerated or strangulated), 49617(Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), recurrent,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); greater than 10 cm, reducible), 49618 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
recurrent, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49621 (Repair of parastomal hernia, any approach (ie,
open, laparoscopic, robotic), initial or recurrent, including placement
of mesh or other prosthesis, when performed; reducible), and 49622
(Repair of parastomal hernia, any approach (ie, open, laparoscopic,
robotic), initial or recurrent, including placement of mesh or other
prosthesis, when performed; incarcerated or strangulated). The RUC
recommended a work RVU of 18.67 for CPT code 49596, 15.55 RVUs for CPT
code 49616, 16.03 RVUs for CPT code 49617, 22.67 RVUs for CPT code
49618, 13.70 RVUs for CPT code 49621, and 17.06 RVUs for CPT code
49622. CPT codes 49596 and 496182 were surveyed and recommended with
one subsequent inpatient hospital visit at a level of CPT code 99233
(subsequent hospital care/day 35 minutes). The RUC recommendations
include an immediate postservice time of 25 minutes for CPT code 49596
and 30 minutes for CPT code 49618. CPT codes 49616, 49617, and 49622
were surveyed and recommended with one subsequent inpatient hospital
visit at a level of CPT code 99232. The RUC recommendations include an
immediate postservice time of 25 minutes for 49616, 28 minutes for CPT
code 49617, and 25 minutes for CPT code 49622. CPT code 49621 was
surveyed and recommended with one subsequent inpatient hospital visit
at a level of CPT code 99231 and an immediate postservice time of 25
minutes.
For purposes of calculating the recommended work RVUs, the RUC
considered these CPT codes to describe an admitted inpatient service,
while we consider the CPT codes to describe outpatient services for
purposes of billing. Therefore, we believe that inpatient work in the
post-operative period should not be included in the valuation. We
believe the 23-hour policy should be applied to these codes. Using the
23-hour policy calculation described above and in the CY 2011 PFS final
rule, we proposed a work RVU of 18.67 for CPT code 49596, 15.55 RVUs
for CPT code 49616, 16.03 RVUs for CPT code 49617, 22.67 RVUs for CPT
code 49618, 13.70 RVUs for CPT code 49621, and 17.06 RVUs for CPT code
49622. We are also proposing revised immediate postservice times for
the reallocation of the time associated with the intraservice portion
of the inpatient hospital visit. We proposed immediate post service
times of 40 minutes for CPT code 49596, 35 minutes for CPT code 49616,
38 minutes for CPT code 49617, 45 minutes for CPT code 49618, 30
minutes for CPT code 49621, and 35 minutes for CPT code 49622.
The following CPT codes have a post-operative period that the RUC
considers to be a same day discharge: CPT code 49591 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); less than 3 cm, reducible) and
49613 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), recurrent, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
reducible). The RUC-recommended a work RVU of 6.27 for CPT code 49591
and 7.75 for CPT code 49613. We disagree with the RUC-recommended RVU
for CPT code 495911 because it falls above the median value for codes
with similar
[[Page 69478]]
times. We proposed a work RVU of 5.96 RVUs based on the intraservice
time ratio, which is the ratio of 90 minutes of intraservice time of a
current hernia repair code--CPT code 49560 (Repair initial incisional
or ventral hernia; reducible) and the 45 minutes of intraservice time
for CPT code 49591. The proposed work RVU of 5.96 is also supported by
reference CPT code 93453 (Combined right and left heart catheterization
including intraprocedural injection(s) for left ventriculography,
imaging supervision and interpretation, when performed). CPT code 93453
has a work RVU of 5.99, the same intraservice time as CPT code 49591(45
minutes), and a slightly higher total time of 113 minutes.
For CPT code 49613, we disagree with the RUC- recommended work RVU
of 7.75, as it is above the median range compared to codes with similar
times. We proposed a work RVU of 7.42 RVUs for CPT code 49613 based off
of the intraservice time ratio of 100 minutes of intraservice time for
a current hernia repair code--CPT code 49565 (Repair recurrent
incisional or ventral hernia; reducible), compared to the 60 minutes of
intraservice time for CPT code 49613. The proposed work RVU of 7.42 is
also supported by reference CPT code 52353 (Cystourethroscopy, with
ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral
catheterization is included)). CPT code 52353 has a work RVU of 7.50
with the same intraservice time of 60 minutes and a very similar total
time of 133 minutes.
CPT code 49623 (Removal of total or near-total non-infected mesh or
other prosthesis at the time of initial or recurrent anterior abdominal
hernia repair or parastomal hernia repair, any approach (ie, open,
laparoscopic, robotic)) is an add-on code. The RUC recommended a work
RVU of 5.0 for CPT code 49623. The RUC recommendation is higher than
the work RVUs for many other CPT add-on codes with similar times. We
proposed a work RVU of 2.61 RVUs for CPT code 49623, based on the
reverse building block methodology. The proposed work RVU of 2.61 is
also supported by reference CPT code 15774 (Grafting of autologous fat
harvested by liposuction technique to face, eyelids, mouth, neck, ears,
orbits, genitalia, hands, and/or feet; each additional 25 cc injectate,
or part thereof (List separately in addition to code for primary
procedure)), which has a work RVU of 2.50 and the same total time of 45
minutes.
We reviewed the RUC-recommended direct PE inputs for all of the
codes within this family. We disagree with the RUC's recommendations of
66 total minutes of clinical staff time for CPT codes 49591 and 49613,
60 total minutes of clinical staff time for CPT codes 49592, 49593,
49594, 49595, 49596, 49614, 49615, 49616, 49617, 49618, 49621, and
49622, and 20 total minutes of clinical staff time for CPT code 15778.
In the CY 2023 PFS proposed rule, we noted that the RUC recommended
090-day pre-service times for all of these codes despite surveying all
of the services as 000-day services. In the CY 2022 PFS final rule (86
FR 65090), we stated we continue to believe that setting and
maintaining clinical labor time and valuation standards provides
greater consistency among codes that share clinical labor tasks and
could improve relativity of values among codes. Therefore, we believe
that the standard clinical labor packages that are in accordance with
the surveyed global period continue to be the most appropriate for
purposes of clinical labor valuation.
The RUC recommendations for CPT codes 49591 and 49613, and CPT
codes 49592, 49593, 49594, 49595, 49596, 49614, 49615, 49616, 49617,
49618, 49621, and 49622, include the standard for 090-day preservice
times for clinical labor activities, which is 60 minutes. For 49591 and
49613 in particular, the RUC also recommended an additional 6 minutes
in the post service period to conduct patient communications. We
disagree with the RUC-recommended 090-day times as these CPT codes were
surveyed by the RUC as 000-day services and should have times
consistent with 000- day services. Therefore, we proposed the standard
clinical labor times for a 000-day extensive package for a total pre-
service clinical staff time of 30 minutes for CPT codes 49591 through
49622 with an additional standard 3 minutes of post-service patient
communications for 49591 and 49613. CPT code 49623 is an add-on code
and does not have RUC-recommended direct PE inputs.
For CPT code 15778, the RUC recommendation is 20 minutes of
clinical staff activities, which is standard for an emergent procedure
package. We do not agree that the service described by CPT code 15778
should be considered an emergent procedure. Therefore, we proposed the
minimal clinical staff package minus pre-service education for CPT code
15778, for a total of 12 clinical staff time minutes.
Comment: We received public comments for this code family that did
not support our proposed RVUs. Commenters stated that they do not agree
with our ``systemic and formulaic'' reduction in work RVUs by the use
of the Reverse Building Block (RBB) methodology. The commenters also
stated that our use of the RBB in the context of the 23-hour policy is
duplicative and results in inappropriately low valuations, in contrast
to their preferred method of magnitude estimation.
Response: We believe that there are multiple appropriate
methodologies for calculating work RVUs, including the RBB method, time
ratios, increments, and survey data. We finalized in the CY 2011 PFS
final rule (75 FR 73328 through 73329), the RBB formula for applying
the 23-hour policy to the work RVUs and the times of the outpatient
service and the same-day E/M codes. We do not believe that it is
duplicative to apply the full 23-hour policy to CPT codes when the RUC
recommendations do not account for the appropriate reduction in work
RVUs; this is relevant for some of the codes in this family as well as
the Intracranial Laser Interstitial Thermal Therapy (LITT) family (CPT
Codes 61736 and 61737) discussed in the CY 2022 PFS final rule (86 FR
65090). We continue to believe the entire 23-hour policy calculation,
as finalized in the CY 2011 PFS final rule, should be completely and
consistently applied where applicable.
Comment: Commenters noted several concerns regarding the
application of the 23-hour policy to this code family. Commenters
stated that they disagree with the additional application of the 23-
hour policy to the CPT codes that the RUC has considered as overnight
with a visit on the same date because they believe that this has
already been accounted for during the survey process magnitude
estimation. Commenters noted that they do not believe that the 23-hour
policy should be applied to the codes that the RUC has considered as
admitted because the patient will likely become an inpatient.
Additionally, the commenters expressed concern that we have added CPT
codes 49596, 49616, 49617, 49618, 49621, and 49622 to the Hospital
Outpatient Prospective Payment System's Inpatient Only List and the
volume being reallocated to the new CPT codes are from inpatient
predecessor codes, CPT codes 49561 and 49566, which is contradictory.
One commenter noted that the post-operative care will be occurring on
the same day as the service and they believe that we did not account
for this. Commenters also noted concern about contradictory policies
regarding the newly revised E/M CPT codes, 99232, 99233, 99238, and
99239, which they noted now represents the same physician work whether
inpatient or outpatient. Commenters opined that the revision to the E/M
[[Page 69479]]
codes renders the 23-hour policy invalid. One commenter also expressed
concern about our assertion that the 23-hour policy can encompass
scenarios where the patient stays multiple overnights in the hospital,
as this is contradictory to our ``Two-Midnight rule'' regarding
inpatient versus outpatient status.
Response: As stated previously, we believe that it is not
duplicative to apply the full 23-hour policy calculation to the CPT
codes that the RUC has considered as overnight with a visit on the same
date. It is not evident from the RUC recommendations provided to us
that the final work RVU was appropriately reduced (per the CY 2011 PFS
final rule formula) consistent with the second step of the 23-hour
calculation. Therefore, we believe the entire calculation should be
applied to the CPT codes that the RUC has considered as overnight with
a visit on the same date. We acknowledge that we proposed to add the
CPT codes that the RUC has considered as admitted to the Hospital
Outpatient Prospective Payment System's Inpatient Only List for 2023.
However, we believe that doing so is not inconsistent with our
proposals for this family. The RUC recommendations include a request to
treat these CPT codes as 000-day global services. As such, regardless
of the inpatient status of the patients, we continue to believe that
000-day global service code families allow for separately billable
post-operative E/M visits. Therefore, we believe it is still
appropriate to subtract the value of the post-operative E/M visit that
the RUC recommended as bundled into the valuations of the codes from
the valuation of the codes. We also acknowledge that the RUC
recommendations include the post-operative work occurring on the same
day of the service. In light of that, we intend to reallocate the
intraservice time from the removed post-operative E/M visit to the
immediate post-service time of the service, as proposed. We believe
that the proposed revisions for CPT codes 99221-99223 and 99231-99233
are not inconsistent with our 23-hour policy as it applies to this code
family; the RUC recommendations referenced in this rule (from April
2021) explicitly identify many of the codes in this family as being
subject to our 23-hour policy. Consistent with discussions in the CY
2011 and CY 2022 PFS final rules cited above, we agree with the RUC
that these codes are subject to the 23-hour policy, and we believe it
is appropriate to fully apply the 23-hour policy to several of the
codes within this family. We again note that the RUC recommendations
request this family be 000-day global services, as such, this allows
for separately billable E/M visits regardless of the patient's
admission status.
We note that we also discussed 000-day global services and
separately billable E/M visits in the CY 2022 PFS final rule relative
to CPT codes 21315 and 21320 (86 FR 65074). We note that we acknowledge
commenter's concerns regarding policy implications as a result of
adopting the E/M inpatient/observation revisions and will take that
into consideration for future rulemaking. Also consistent with the CY
2011 and CY 2022 final rules, we disagree with the commenter's concerns
regarding multiple overnights and the application of the 23-hour
policy. We stated in the CY 2022 final rule cited above that the 23-
hour policy can encompass several scenarios, including multiple
overnight stays (87 FR 45860). We did not propose any changes to the
previously finalized 23-hour policy nor a policy regarding ``Two-
Midnights''. Therefore, we believe it is still consistent to fully
apply the 23-hour policy to the codes within this family that the RUC
considers overnight with a visit on the same date and admitted.
Comment: One commenter stated that they have concerns with our CY
2011 PFS final rule policy (75 FR 73226) to reallocate the intraservice
time of the inpatient level E/M postoperative visit to the immediate
postservice time of the service. The commenter noted that the E/M
services furnished post operatively are separate and distinct from the
main surgical procedure and there is no difference in work to provide a
separate E/M service furnished to a postoperative patient by the
surgeon compared to another provider. Additionally, the commenter
stated that we have not provided a rationale or evidence for this
policy and the components of it, such as the intraservice vs. total
time and the chosen intensity. The commenter also noted that this
policy of reallocating the intraservice time from the inpatient level
E/M postoperative visit to the immediate postservice time of the
service is discriminatory to surgeons and the 23-hour policy overall is
flawed and not in line with statute.
Response: We acknowledge that some commenters had concerns
regarding various aspects of our 23-hour policy and CMS's full
application of the policy to the CPT codes in this family. We refer
readers to our discussion regarding the policy and its application in
the CY 2011 and CY 2022 PFS final rules, cited above. Since we did not
propose any changes to our 23-hour policy, its application or
calculation, we are not finalizing any changes to the policy for CY
2023.
Comment: Commenters disagreed with our proposed valuation
methodologies for several specific codes within the family. For CPT
codes 49591 and 49613, commenters disagreed with our use of the
intraservice time ratio as a valuation methodology. Commenters noted
that using ratios treats all components of physician time as having
identical intensities. Commenters also noted that we did not adequately
account for the bundled work of the placement of mesh, that previously
was reported separately. Commenters also disagreed with our chosen
supporting reference codes, as they noted their clinical nature and
intensity is not appropriate for purposes of comparison. For CPT code
49623, commenters disagreed with our use of the RBB methodology as the
service is currently not described by an existing CPT code and is
instead reported using an unlisted code or with modifier -22.
Response: We continue to believe that intraservice time ratios are
a valid and appropriate tool for determining work RVUs. We reiterate
that, consistent with the statute, we are required to value the work
RVU based on the relative resources involved in furnishing the service,
which include time and intensity. In accordance with the statute, we
believe that changes in time and intensity must be accounted for when
developing work RVUs. When our review of recommended values reveals
that changes in the resource of time are not accounted for in a RUC-
recommended RVU, the obligation to account for that change when
establishing the proposed and final work RVUs remains. For more details
on our methodology for developing work RVUs, we direct readers to the
discussion on time ratios as discussed above in this Valuation of
Specific Codes section.
For CPT codes 49591 and 49613, we believe that the RUC recommended
work RVUs are overvalued compared to similar codes with similar
intraservice times. We also do not believe that our supporting
reference codes must have similar clinical characteristics for purposes
of comparison due to the inherent relativity of the PFS. Also, for CPT
code 49591, we found multiple other supporting reference codes that
have similar and even lower intraservice and total times, but RVUs much
lower than the RUC recommended value for this code. For example, CPT
code 33289 (Transcatheter implantation of wireless pulmonary artery
pressure sensor for long-term hemodynamic monitoring, including
deployment and calibration of
[[Page 69480]]
the sensor, right heart catheterization, selective pulmonary
catheterization, radiological supervision and interpretation, and
pulmonary artery angiography, when performed) was reviewed by the RUC
in 2018. This CPT code has 40 minutes of intraservice time, 111 minutes
of total time, a work RVU of 6.0 and a nearly identical intensity of
0.115 as compared to the RUC derived intensity of 0.113 for their
recommended work RVU value for this code. Therefore, we believe a work
RVU of 5.96 for CPT code 49591 is an appropriate valuation based on CPT
codes with similar times and intensities. For CPT code 49613, we
disagree that our supporting reference code (CPT code 52353) is
inappropriate for purposes of comparison. In addition to the similar
times, it also has an intensity of 0.101 that is very close to the RUC
derived intensity of 0.105 for their recommendation for this code.
Therefore, we believe a work RVU of 7.42 for CPT code 49613 is an
appropriate valuation based on CPT codes with similar times and
intensities.
For CPT code 49623, we disagree that it is inappropriate to use the
RBB to reach a work RVU valuation. We believe that there are multiple
valuation methodologies that we can use to calculate work RVUs for CPT
codes, all of which align with the statutory requirement to value work
RVUs based on the relative resources involved in furnishing the
service, which include time and intensity. However, we agree with
commenters that there are other more appropriate CPT codes that could
be used in the RBB calculation for purposes of comparison. For example,
CPT code 11008 (Removal of prosthetic material or mesh, abdominal wall
for infection (e.g., for chronic or recurrent mesh infection or
necrotizing soft tissue infection) (List separately in addition to code
for primary procedure)) has a total time of 60 minutes and an RVU of
5.0. Using CPT code 11008 in the RBB calculation yields a work RVU of
3.75 for CPT code 49623. We believe that CPT code 11008 is a more
appropriate code to use within the RBB calculation for CPT code 49623.
We also support a work RVU of 3.75 with a reference code, CPT code
63048 (Laminectomy, facetectomy and foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s], [e.g., spinal or lateral recess stenosis]), single vertebral
segment; each additional segment, cervical, thoracic, or lumbar (List
separately in addition to code for primary procedure)), which has the
same total time of 45 minutes and work RVU of 3.47. Therefore, we are
finalizing a work RVU of 3.75 for CPT code 49623.
Comment: Commenters did not support our proposed practice expense
(PE) clinical staff time packages for this code family. Commenters
disagreed with using a 000/010-day extensive package and believe that
the 090-day clinical staff time package is still appropriate because
the change to a 000-day global period from a 090-day global period was
requested by the RUC to account for the variable post-operative care
and not the procedural clinical staff work that is associated with it.
One commenter also noted that in April 2022, the RUC created a new
clinical staff time package for 000/010-day global period codes that
had previously been 090-day global period codes. Commenters also
requested that we accept the RUC's recommendation to use the standard
emergent procedure package, with 20 minutes of clinical staff
activities e for CPT code 15778.
Response: As stated in the CY 2023 PFS proposed rule (87 FR 45909),
we continue to believe that maintaining clinical labor standards
provides greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. We
reviewed the individual codes in question and concluded that the use of
000-day or 010-day global period standards for ``Extensive use of
Clinical Staff'' would be most typical and consistent in these cases.
Upon further clinical review, we also continue to believe that the most
appropriate clinical staff package for CPT code 15778 is the minimal
staff package minus pre-service education. We are pleased to learn that
the RUC has developed a new clinical staff package for CPT codes that
are transitioning from a 90-day global period. This clinical staff
package was not included in the recommendations submitted for this code
family.
After consideration of the public comments, we are finalizing the
work RVU values for this code family as proposed, with the exception of
CPT code 49623, as indicated above. We are also finalizing all PE
inputs as proposed.
(2) Removal of Sutures or Staples (CPT Codes 15851, 15853, and 15854)
In October 2021, the CPT Editorial Panel approved the deletion of
CPT code 15850 and revised CPT code 15851 (Removal of sutures or
staples requiring anesthesia (ie, general anesthesia, moderate
sedation)), and created two new related CPT add-on codes, 15853 and
15854, to describe Removal of sutures or staples requiring anesthesia
(i.e., general anesthesia, moderate sedation). The RUC reviewed the
three codes: 15851, 15853 and 15854 at the January 2022 RUC meeting.
After reviewing CPT code 15851, we proposed the RUC-recommended
work RVU of 1.10 for CPT code 15851. CPT codes 15853 (Removal of
sutures OR staples not requiring anesthesia (List separately in
addition to E/M code)), and 15854 (Removal of sutures OR staples not
requiring anesthesia (List separately in addition to E/M code) are
valued by the RUC as PE-only codes. The RUC did not recommend any work
inputs for these two add-on codes and we did not propose any work RVU
refinements.
We also proposed the RUC-recommended direct PE inputs for CPT codes
15851, 15853, and 15854 without refinement.
Comment: One commenter expressed support for our proposed
valuations for the family of codes that describe the removal of sutures
or staples.
Response: We appreciate the commenter's support, and we are
finalizing our proposal of the RUC-recommended direct PE inputs for CPT
codes 15851, 15853, and 15854 without refinement.
(3) Arthrodesis Decompression (CPT Codes 22630, 22632, 22633, 22634,
63052, and 63053)
In October 2020, the CPT Editorial Panel approved the revision of
four codes describing arthrodesis and the addition of two new add-on
codes, CPT codes 63052 (Laminectomy, facetectomy, or foraminotomy
(unilateral or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[s] [e.g., spinal or lateral recess stenosis]),
during posterior interbody arthrodesis, lumbar; single vertebral
segment (List separately in addition to code for primary procedure))
and 63053 (Laminectomy, facetectomy, or foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s] [e.g., spinal or lateral recess stenosis]), during posterior
interbody arthrodesis, lumbar; each additional segment (List separately
in addition to code for primary procedure)), to report laminectomy,
facetectomy, or foraminotomy during posterior interbody arthrodesis,
lumbar to more appropriately identify the decompression that may be
separately reported. In January 2021, the RUC reviewed the survey
results for the two new codes and expressed concern that the four base
codes had not been surveyed along with the two new add-
[[Page 69481]]
on codes. The RUC recommended that the entire family be resurveyed and
presented for review at its April 2021 meeting. The RUC suggested that
until new values could be established, interim values be established
for CPT codes 63052 and 63053, which CMS revised for CY 2022 based on
the survey data and RUC review available to us at the time of the
development of the CY 2022 PFS proposed rule. We have noted in similar
circumstances, such as the minimally invasive glaucoma surgery (MIGS)
procedures with cataract surgery discussed in the CY 2022 PFS final
rule (86 FR 65097), that it is best for entire code families to be
surveyed at the same time. We also noted that we finalized a policy in
the CY 2015 PFS final rule (79 FR 67602 through 67609) to make all
changes in the work and MP RVUs and the direct PE inputs for new,
revised, and potentially misvalued services under the PFS by proposing
and then finalizing such changes through notice and comment rulemaking,
as opposed to initially finalizing changes on an interim final basis.
For CPT codes 22630 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; lumbar), 22633
(Arthrodesis, combined posterior or posterolateral technique with
posterior interbody technique including laminectomy and/or discectomy
sufficient to prepare interspace (other than for decompression), single
interspace; lumbar), 22634 (Arthrodesis, combined posterior or
posterolateral technique with posterior interbody technique including
laminectomy and/or discectomy sufficient to prepare interspace (other
than for decompression), single interspace; each additional interspace
and segment (List separately in addition to code for primary
procedure)), 63052, and 63053, we disagreed with the RUC-recommended
work RVUs of 22.09, 26.80, 7.96, 5.70, and 5.00, respectively, because
these values do not account for the surveyed changes in time, and we
proposed a work RVU of 20.42 for CPT code 22630, a work RVU of 24.83
for CPT code 22633, a work RVU of 7.30 for CPT code 22634, the current
work RVU of 4.25 for CPT code 63052 and a work RVU of 3.78 for CPT code
63053. For CPT code 22632 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; each additional interspace
(List separately in addition to code for primary procedure)), we agreed
with the RUC-recommended maintenance of the current work RVU of 5.22,
as there were no surveyed changes in time.
We proposed a work RVU of 20.42 for CPT code 22630 based on the
reverse building block methodology to account for the surveyed 8-minute
decrease in total time, 10-minute decrease in pre-service time, 30-
minute decrease in intraservice time, and 2-minute decrease in
immediate post-service time. We believe that since the two components
of work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, it would be inappropriate to maintain the current work RVU
given the significant decrease in intraservice time without adequate
justification of increased intensity. There are currently three CPT
code 99231 (Subsequent hospital care/day 15 minutes) and four CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits bundled in
CPT code 22630's 090-day global period and valuation. The RUC
recommended that the post-operative period for CPT code 22630 change to
include two CPT code 99232 (subsequent hospital care/day 25 minutes),
one CPT code 99231, one CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter.), and two CPT code 99213 visits. The currently bundled post-
operative visits total to 6.16 work RVUs, whereas the RUC-recommended
changes to the post-operative visits total 6.98 work RVUs, resulting in
a 0.82 work RVU increase (if no other changes occurred to CPT code
22630). The proposed work RVU of 20.42 for CPT code 22630 maintains the
same IWPUT of 0.067 and maintains the 0.82 work RVU difference between
the current and RUC-recommended post-operative period. We believe this
proposed work RVU is more accurate than the RUC-recommended work RVU
because there was no obvious or explicitly stated rationale in the
RUC's recommendations for the change in intensity of intraservice time,
and there was a 30-minute decrease in intraservice time for CPT code
22630. We believe that since the two components of work are time and
intensity, absent an obvious or explicitly stated rationale for why the
relative intensity of a given procedure has increased, it would have
been inappropriate to propose the RUC-recommended work RVU for CPT code
22630.
Similarly, we proposed a work RVU of 24.83 for CPT code 22633,
based on the reverse building block methodology, to account for the
surveyed 56-minute decrease in total time, 20-minute decrease in
intraservice time, and 33-minute decrease in post-operative time. The
reverse building block methodology accounts for the time and intensity
of post-operative work through long-established and agreed-upon times
and intensities for bundled post-operative visits, and accurately
adjusts for the changes occurring in the post-operative period. There
is currently one post-operative CPT code 99232, two CPT code 99233
(Subsequent hospital care/day 35 minutes), and three CPT code 99213
visits bundled in CPT code 22633's valuation. The RUC recommended that
the post-operative period for CPT code 22633 change to include two CPT
code 99232, one CPT code 99231, one CPT code 99214 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making. When using
time for code selection, 30-39 minutes of total time is spent on the
date of the encounter.), and two CPT code 99213 visits. The currently
bundled post-operative visits total to 8.30 work RVUs, whereas the RUC-
recommended changes to the post-operative visits total 6.98 work RVUs,
resulting in a 1.32 work RVU decrease (if no other changes occurred to
CPT code 22633). Using the reverse building block methodology, the
proposed work RVU of 24.83 maintains the same IWPUT of 0.080 and the
1.32 work RVU difference between the current and RUC-recommended post-
operative period. We believe this proposed work RVU is more accurate
than the RUC-recommended work RVU because there was no obvious or
explicitly stated rationale in the RUC's recommendations for the change
in intensity of intraservice time, and there was a 20-minute decrease
in intraservice time for CPT code 22633. We believe that since the two
components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, it would have
[[Page 69482]]
been inappropriate to propose the RUC-recommended work RVU decrease of
0.95, which is only about three-quarters of the established decrease in
work RVU of 1.32 and intensity from the changes in the post-operative
period alone. We also considered the apparent decrease in intraservice
time and the lack of an adequate justification for increased intensity
to arrive at our proposed work RVU of 24.83 for CPT code 22633.
We proposed a work RVU of 7.30 for CPT code 22634 based on a
comparison to its base code, CPT code 22633. We used the proposed work
RVU of 24.83 for the parent CPT code (22633) as the numerator and the
current work RVU for CPT code 22633 of 27.75 as the denominator, and
multiplied that fraction by the current work RVU of 8.16 for CPT code
22634 to arrive at a proportionate proposed work RVU of 7.30 for CPT
code 22634 ((24.83/27.75) * 8.16) = 7.30). The proposed work RVU
accounts for the decrease in intraservice time and is well bracketed by
CPT code 34820 (Open iliac artery exposure for delivery of endovascular
prosthesis or iliac occlusion during endovascular therapy, by abdominal
or retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 7.00 work RVUs with an
intraservice time of 60 minutes, and CPT code 34833 (Open iliac artery
exposure with creation of conduit for delivery of endovascular
prosthesis or for establishment of cardiopulmonary bypass, by abdominal
or retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 8.16 work RVUs with an
intraservice time of 72 minutes.
CPT codes 63052 and 63053 were new add-on codes to report
decompression when performed in conjunction with posterior interbody
arthrodesis at the same interspace for CY 2022. The proposed work RVU
for CPT code 63052 would maintain the current work RVU, despite a
surveyed change in time. In the CY 2022 PFS final rule, we finalized a
work RVU of 4.25 for CPT code 63052 for CY 2022 based on a crosswalk to
CPT code 22853 (Insertion of interbody biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to intervertebral
disc space in conjunction with interbody arthrodesis, each interspace
(List separately in addition to code for primary procedure)), which has
a work RVU of 4.25 and an intraservice time of 45 minutes. Despite a
surveyed 5-minute intraservice time increase for CPT code 63052, we
believe the crosswalk to CPT code 22853 is still valid, given that only
3 months passed between the two surveys, as it now has the same
intraservice time as CPT code 63052, is a spinal procedure, and is an
add-on code to the same base codes as CPT code 63052. Commenters on the
CY 2022 PFS proposed rule supported the bracket of key reference
service CPT code 22552 (Arthrodesis, anterior interbody, including disc
space preparation, discectomy, osteophytectomy and decompression of
spinal cord and/or nerve roots; cervical below C2, each additional
interspace (List separately in addition to code for primary procedure))
and MPC CPT code 34812 (Open femoral artery exposure for delivery of
endovascular prosthesis, by groin incision, unilateral (List separately
in addition to code for primary procedure)), and therefore, we noted
that the final work RVU of 4.25 for CY 2022 was supported by the
commenters (86 FR 65092). CPT code 22552 has a work RVU of 6.50 and an
intraservice time of 45 minutes, and commenters noted that CPT code
22552 has a higher intensity as anticipated for a surgical procedure in
comparison with a lumbar procedure. CPT code 34812 has a work RVU of
4.13 and 40 minutes of intraservice time, and commenters noted that
this code involves open femoral artery exposure by groin incision and
closure of the wound, typically for separately reported delivery of an
endovascular prosthesis for an asymptomatic infrarenal abdominal aortic
aneurysm. In comparison, exposure and closure for CPT code 63052 are
performed as part of the primary arthrodesis code and the intraservice
time includes higher intensity bony and soft tissue resection, and
therefore, although both codes require the same time, the physician
work and intensity of CPT code 63052 is greater than CPT code 34812.
In the CY 2022 PFS final rule, we finalized a work RVU of 3.19 for
CPT code 63053 for CY 2022 based on an intraservice time ratio between
CPT codes 63052 and 63053 ((30 minutes/40 minutes) * 4.25 = 3.19). We
believe this intraservice time ratio between the two CPT codes is still
valid, given that only 3 months passed between the two surveys, and
therefore, we proposed a work RVU of 3.78 based on the surveyed time
changes for CPT codes 63052 and 63053 ((40 minutes/45 minutes) * 4.25 =
3.78) in order to maintain consistency with previous analysis of time
and intensity of these two add-on codes. Due to the lack of an obvious
or explicitly stated rationale in the RUC's April recommendations for
the change in intensity between the January 2021 and April 2021
surveys, we relied on the changes in surveyed time to calculate the
proposed work RVUs for CPT codes 63052 and 63053.
We proposed the RUC-recommended PE inputs for CPT codes 22630 and
22633.
Comment: Some commenters disagreed with our proposed work RVUs for
CPT codes 22630 and 22633, stating that the changes in time for these
CPT codes are attributed to changes in technology that reduced operator
time but increased the intensity of the services provided within that
time. The commenters stated that routine use of fluoroscopy to obtain
intraoperative films may decrease the time required for these
procedures, but the surgeon is using that data in real-time to
determine the positioning and safety of hardware placement. The
commenters also stated that using high-speed electric drills eliminates
the routine need to change out air pressure tanks required for
pneumatic drills, but the differences in torque and handling change the
``feel'' of a procedure involving a high-speed drill close to the
spinal nerves. The commenters stated that the decreases in
intraoperative time is due to reduction in time devoted to low-risk and
less intense portions of the procedures (for example, waiting on a
radiology technician to obtain an intraoperative cross-table lateral
film; waiting for X-ray films to be developed after a flat plate film
was taken and waiting for air tanks to be changed out for a pneumatic
drill). The commenters contended that the decrease in intraservice time
is matched by a related increase in the intensity of the procedure
itself, as the lower intensity aspects of the procedure have been
eliminated, leaving the high-risk elements of the procedures to be
provided in less time with greater intensity.
Response: We note that we proposed a work RVU of 20.42 for CPT code
22630 based on the reverse building block methodology to account for
the surveyed 8-minute decrease in total time, 10-minute decrease in
pre-service time, 30-minute decrease in intraservice time, and 2-minute
decrease in immediate post-service time. We believed it would be
inappropriate to maintain the current work RVU for CPT code 22630 given
the significant decrease in intraservice time and the absence of an
adequate justification of increased intensity. However, after
consideration of the commenters' rationale for decreased time and
increased intensity, we are finalizing the RUC recommended work RVUs of
22.09 and 26.80 for CPT codes 22630 and
[[Page 69483]]
22633, respectively, as we believe the RUC recommended work RVUs
adequately account for the changes in resources. We appreciate the
commenters additional input regarding intensity, but remind interested
parties that both time and intensity changes must be addressed in the
summary of recommendations. We remind interested parties that, since
the two components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. If the RUC's recommendations
appear to disregard or dismiss the changes in time, without a
persuasive explanation of why such a change should not be accounted for
in the overall work of the service, then we generally use one of the
methodologies discussed above to identify potential work RVUs,
including the methodologies intended to account for the changes in the
resources involved in furnishing the procedure.
We note that we proposed a work RVU of 7.30 for CPT code 22634
based on a comparison to our proposed work RVU for its base code, CPT
code 22633, which we are not finalizing. Given that we have decided to
finalize the RUC recommended work RVU of 26.80 for CPT code 22633, in
order to maintain for relativity within the family, we are also
finalizing the RUC recommended work RVU of 7.96 for CPT code 22634.
Comment: A few commenters urged CMS to finalize the RUC recommended
work RVUs for CPT codes 63052 and 63053, stating that the intraservice
time for CPT code 63035 increased by five minutes to a total of 45
minutes and that the time spent performing this procedure is
essentially all high-risk. The commenters asserted that the lower
intensity surgical exposure activities were already completed with the
base code, so the physician work of CPT code 63052 involves only the
high intensity, dangerous aspects of neural element and spinal cord
decompression. Similarly, some commenters disagreed with our use of an
intraservice time ratio to value CPT code 63053. Commenters stated that
this approach ignores magnitude estimation and stated that the second
survey included more respondents who routinely perform this procedure.
Commenters stated that the new survey from April 2021, which included
all six codes in the family, generated an intraservice time of 40
minutes, a difference of five minutes between CPT codes 63052 and
63053, which is believed to be a more accurate reflection of the
difference in work between laminectomy/facetectomy/foraminotomy with
decompression of the first segment and an additional segment versus the
January 2021 survey, which generated an intraservice time difference of
ten minutes between CPT codes 63052 and 63053.
Response: We agree with the commenters that an intraservice time
difference of 5 minutes between CPT codes 63052 and 63053 is a
reflection of the difference in work between laminectomy/facetectomy/
foraminotomy with decompression of the first segment and an additional
segment, and therefore, we proposed the RUC recommended physician time
values for CPT codes 63052 and 63053. However, we continue to believe
that, despite a surveyed 5-minute intraservice time increase for CPT
code 63052, the crosswalk to CPT code 22853 is still valid to support a
work RVU of 4.25 for CPT code 63052, given that only 3 months passed
between the two surveys, that it now has the same intraservice time as
CPT code 22853, are both spinal procedures, and are both add-on codes
to the same base codes. We reiterate that commenters on the CY 2022 PFS
proposed rule supported the bracket of key reference service CPT code
22552 (Arthrodesis, anterior interbody, including disc space
preparation, discectomy, osteophytectomy and decompression of spinal
cord and/or nerve roots; cervical below C2, each additional interspace
(List separately in addition to code for primary procedure)) and MPC
CPT code 34812 (Open femoral artery exposure for delivery of
endovascular prosthesis, by groin incision, unilateral (List separately
in addition to code for primary procedure)), and therefore, we noted
that the final work RVU of 4.25 for CY 2022 was supported by the
commenters (86 FR 65092). CPT code 22552 has a work RVU of 6.50 and an
intraservice time of 45 minutes, and commenters noted that CPT code
22552 has a higher intensity as anticipated for a surgical procedure
and in comparison with a lumbar procedure. CPT code 34812 has a work
RVU of 4.13 and 40 minutes of intraservice time, and commenters noted
that this code involves open femoral artery exposure by groin incision
and closure of the wound, typically for separately reported delivery of
an endovascular prosthesis for an asymptomatic infrarenal abdominal
aortic aneurysm. In comparison, exposure and closure for CPT code 63052
are performed as part of the primary arthrodesis code and the
intraservice time includes higher intensity bony and soft tissue
resection, and therefore, although both codes require the same time,
the physician work and intensity of CPT code 63052 is greater than CPT
code 34812. Therefore, we are finalizing a work RVU of 4.25 for CPT
code 63052.
We remind commenters that in the CY 2022 PFS final rule, we
finalized a work RVU of 3.19 for CPT code 63053 for CY 2022 based on an
intraservice time ratio between CPT codes 63052 and 63053 ((30 minutes/
40 minutes) * 4.25 = 3.19). We continue to believe this intraservice
time ratio between the two CPT codes is still valid, given that only 3
months passed between the two surveys, and therefore, we are finalizing
a work RVU of 3.78 based on the surveyed time changes for CPT codes
63052 and 63053 ((40 minutes/45 minutes) * 4.25 = 3.78) in order to
maintain consistency with previous analysis of time and intensity of
these two add-on codes. We reiterate that, due to the lack of an
obvious or explicitly stated rationale in the RUC's April
recommendations for the change in intensity between the January 2021
and April 2021 surveys, we relied on the changes in surveyed time to
calculate the work RVU for CPT code 63053.
We are finalizing the RUC-recommended PE inputs for CPT codes 22630
and 22633, as proposed.
(4) Total Disc Arthroplasty (CPT Codes 22857 and 22860)
In September 2021, the CPT Editorial Panel created CPT Category I
code 22860 to describe Total disc arthroplasty (artificial disc),
anterior approach, including discectomy to prepare interspace (other
than for decompression); second interspace, lumbar (List separately in
addition to code for primary procedure) and replace CPT Category III
code 0163T (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression), each additional interspace, lumbar (List separately in
addition to code for primary procedure)), which prompted CPT codes
22860 and 22857 (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression); single interspace, lumbar) to be surveyed for the
January 2022 RUC meeting. At the January 2022 RUC meeting, the
specialty societies indicated, and the RUC agreed, that the survey
results for both CPT codes 22857 and 22860 were erroneous and that the
codes should be resurveyed for the April 2022 RUC meeting. Therefore,
we proposed to maintain the RUC-recommended work RVU of 27.13 for
[[Page 69484]]
CPT code 22857 and contractor pricing for CPT code 22860 for CY 2023.
We will revisit the valuations of CPT codes 22857 and 22860 in future
rulemaking when we review the April 2022 RUC recommendations, based on
our annual review process discussed in the background section of this
final rule.
We did not receive comments on our proposals for this code family
and we are finalizing the values as proposed.
(5) Insertion of Spinal Stability Distractive Device (CPT Codes 22869
and 22870)
For CPT codes 22869 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without open decompression or fusion,
including image guidance when performed, lumbar; single level) and
22870 (Insertion of interlaminar/interspinous process stabilization/
distraction device, without open decompression or fusion, including
image guidance when performed, lumbar; second level (List separately in
addition to code for primary procedure)), we proposed to maintain the
current work RVUs of 7.03 and 2.34, respectively. We proposed the RUC-
recommended direct PE inputs for CPT code 22869 without refinement.
We did not receive comments on our proposals for this code family
and we are finalizing the values as proposed.
(6) Knee Arthroplasty (CPT Codes 27446 and 27447)
CPT codes 27446 (Arthroplasty, knee, condyle and plateau; medial OR
lateral compartment) and 27447 (Arthroplasty, knee, condyle and
plateau; medial AND lateral compartments with or without patella
resurfacing (total knee arthroplasty)) were reviewed by the RUC in
April 2021. We previously reviewed CPT code 27447 in the CY 2021 PFS
final rule; (see 85 FR 84609 and 84610 for our previous discussion).
The RUC proposed a revised survey instrument to ask about additional
pre-operative time and resources spent on pre-optimization patient
work. The RUC agreed that the pre-service planning activities are being
performed routinely for the typical patient but the inclusion of this
work is not reflected in the 090-day global period structure. The RUC
indicated that separate planning codes may be developed, or current
codes such as the prolonged service codes may be reported for these
activities.
We proposed the RUC-recommended work RVU of 17.13 for CPT code
27446. The survey 25th percentile actually showed an increase in work
RVU even though there was a decrease in total time. One post facility
visit, CPT code 99232 (Subsequent hospital care/day 25 minutes), was
removed and replaced with CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter) a post-operative visit in the office. Given a decrease in
the total time spent and a lower level post-operative visit, it is
reasonable that the work RVU went down. There was no change in the
global period.
For CPT code 27447, the RUC reaffirmed the same valuation that it
recommended for the CY 2021 PFS rulemaking cycle. Since we did not
receive any new information regarding this code, we did not propose to
change our previously finalized values (see 85 FR 84609 and 84610 for
our previous discussion of this code in the CY 2021 PFS final rule). We
proposed to maintain a work RVU of 19.60 for CPT code 27447, the value
that we previously finalized through rulemaking. We proposed the RUC-
recommended direct PE inputs for CPT code 27446 and we proposed to
maintain the direct PE inputs for CPT code 27447.
Comment: One commenter, representing interested parties who furnish
these services, agreed with the RUC recommendation, but noted that CPT
code 27447 has been undervalued since its reduction in 2021 and noted
the current work RVU is based on the AMA RUC's recommendations
following the 2019 survey. This commenter and other interested parties
previously argued to maintain the then current work RVU of 20.72, which
was lower than the survey median. The commenter claimed that CPT codes
27447 and 27130 are undervalued due to the RUC and CMS utilizing
different percentiles from surveys to assign the work RVUs and
recommended that CMS adopt a policy to base work RVUs uniformly on the
same percentile of physician survey results as the RUC. We did not make
any proposals for CPT code 27130.
The commenter appreciated CMS discussing the concept of pre-
optimization time for these services in the proposed rule and provided
further clarification with regard to the RUC survey. The commenter
noted that the RUC specifically rejected a proposal for a revised
survey instrument to ask about additional pre-operative time and
resources spent on pre-optimization patient work. Additionally, the use
of current prolonged services, CPT codes 99358 and 99359 was suggested;
however, it was noted that these codes could not be used in conjunction
with CPT codes 27446 and 27447, given the standard of practice includes
preservice time over several days and not one single day, as stated in
the code descriptor for CPT codes 27446 and 27447. The commenter noted
it continues to work with the AMA and CPT to clarify if there are
existing codes to bill for pre-optimization time.
The commenter was in support of the proposed RVUs for PE and
malpractice for CPT code 27447. The commenter generally supported
increased payment rates to facilities for arthroplasty due to the
extreme complexity of the procedure, innovations in the standard of
care and outcomes, and to recognize increased costs through the COVID-
19 public health emergency (PHE). Nevertheless, the ongoing annual
increases in Medicare facility payments for arthroplasty present a
stark contrast with severely decreasing Medicare physician payments for
arthroplasty.
Response: We thank the commenter for their support of our proposal
and appreciate the commenters continued engagement with the AMA and the
CPT to clarify if there are existing codes to bill for pre-optimization
time. We are finalizing the values as proposed for CPT codes 27446 and
27447.
(7) Endovascular Pulmonary Arterial Revascularization (CPT Codes 33900,
33901, 33902, 33903, and 33904)
At the February 2021 meeting of the CPT Editorial Panel, CPT
approved a new family of Category I CPT codes to describe percutaneous
endovascular repair of pulmonary artery stenosis (PAS) by stent
replacement. CPT codes 33900 through 33904 were surveyed by the RUC at
the October 2021 RUC meeting.
We disagree with the RUC-recommended work RVU of 14.0 for CPT code
33900 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 11.03 for CPT code 33900. A work RVU of 11.03 is supported by a
bracket of reference CPT codes, including CPT code 61650 and CPT code
61640. CPT code 61650 (Endovascular intracranial prolonged
administration of pharmacologic agent(s) other than for thrombolysis,
arterial, including catheter placement, diagnostic angiography, and
imaging guidance;
[[Page 69485]]
initial vascular territory) has a work RVU of 10.0 and the same
intraservice time of 90 minutes and the same total time of 206 minutes.
CPT code 61640 (Balloon dilatation of intracranial vasospasm,
percutaneous; initial vessel) has a work RVU of 12.32 and an
intraservice time of 90 minutes and a higher total time of 233 minutes.
There are no direct PE inputs for CPT Code 33900.
We disagree with the RUC-recommended work RVU of 18.0 for CPT code
33901 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 14.50. A work RVU of 14.50 is supported by a reference CPT
code--CPT code 11005. CPT code 11005 (Debridement of skin, subcutaneous
tissue, muscle and fascia for necrotizing soft tissue infection;
abdominal wall, with or without fascial closure) has a work RVU of
14.24 and the same intraservice time of 120 minutes and nearly the same
total time of 235 minutes.
There are no direct PE inputs for CPT Code 33901.
We disagree with the RUC-recommended work RVU of 17.33 for CPT code
33902 (Percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 14.0. A work RVU of 14.0 is supported by a reference CPT code--
CPT code 61640. CPT code 61640 (Balloon dilatation of intracranial
vasospasm, percutaneous; initial vessel) has a work RVU of 12.32 and
the same intraservice time of 90 minutes and a higher total time of 233
minutes.
There are no direct PE inputs for CPT Code 33902.
We disagree with the RUC-recommended work RVU 20.0 for CPT code
33903 (percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. Although we disagree with the RUC-recommended
work RVU, we concur that the relative difference in work between CPT
codes 33901 and 33903 is equivalent to the RUC-recommended interval of
2.0 RVUs. Therefore, we proposed a work RVU of 16.50 for CPT code
33903, based on the recommended interval of 2.0 additional RVUs above
our proposed work RVU of 14.50 for CPT code 33901. A work RVU of 16.50
is also supported by a reference code--CPT code 11005. CPT code 11005
(Debridement of skin, subcutaneous tissue, muscle and fascia for
necrotizing soft tissue infection; abdominal wall, with or without
fascial closure) has a work RVU of 14.24 and the same intraservice time
of 120 minutes and a higher total time of 265 minutes.
There are no direct PE inputs for CPT Code 33903.
We disagree with the RUC-recommended RVU of 7.27 for CPT code 33904
(Percutaneous pulmonary artery revascularization by stent placement,
each additional vessel or separate lesion, normal or abnormal
connections (list separately in addition to code for primary procedure)
(use 33904 in conjunction with 33900, 33901, 33902, 33903)). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We proposed the survey 25th percentile work
RVU of 5.53. A work RVU of 5.53 is supported by a reference code--CPT
code 57267. CPT code 57267 (Insertion of mesh or other prosthesis for
repair of pelvic floor defect, each site (anterior, posterior
compartment), vaginal approach (List separately in addition to code for
primary procedure) has a work RVU of 4.88 and the same time of 45
minutes.
There are no direct PE inputs for CPT code 33904.
Comment: Commenters disagree with our proposed valuations for all
of the codes within this family. Commenters asserted that we failed to
properly justify the decrease for each CPT code because we did not
provide a clinical rationale. One commenter stated that the RUC
intentionally did not use the survey 25th percentile value because the
RUC believes the clinical nature is vastly different than currently
described by similar coding and more intense. Therefore, commenters
noted that we should accept the RUC-recommended survey median values.
For CPT codes 33900, 33901, 33902, and 33904, commenters disagreed with
our chosen supporting reference codes. They noted that the CPT codes
are not clinically similar and the CPT codes that the RUC recommended
are more appropriate for purposes of comparison. Commenters also noted
that we did not maintain the RUC recommended relativity within the code
family that accounts for the change from unilateral to bilateral
anatomically. For CPT code 33903, a commenter disagreed with our use of
the incremental methodology. The commenter noted that using increments
forms a linear relationship between RVUs, which is not appropriate.
Response: We disagree with commenters that supporting reference
codes must have similar clinical characteristics to be appropriate for
purposes of reaching valuations. We believe that the inherent
relativity of the PFS is such that all codes can be used for purposes
of comparison, while considering time and intensity. We maintain that
the RUC recommended work RVU values for CPT codes 33900-33904 are
overvalued relative to codes with similar times and intensities. For
example, CPT code 11004 (Debridement of skin, subcutaneous tissue,
muscle and fascia for necrotizing soft tissue infection; external
genitalia and perineum), has a work RVU of 10.80, an intraservice time
of 90 minutes and a total time of 280 minutes. This is the same
intraservice time and a significantly higher total time than CPT code
33900 and is almost 3 RVUs less than the RUC recommended value of 14.0
for this CPT code. We also disagree that we did not maintain relativity
within the family. We believe that our proposed RVUs account for the
recommended changes in time within the family as the procedure changes
from unilateral to bilateral and is further supported by our reference
codes with similar times. For example, for CPT code 33903, we used the
incremental difference between the RUC recommended values for CPT codes
33901 and 33903 (2 RVUs) to reach our proposed value of 16.50 RVUs for
CPT code 33903. This value is higher than the 25th percentile and
accounts for the change in intensity from unilateral to bilateral. We
also believe the use of an incremental difference between codes is a
valid methodology for setting values, especially in valuing services
within a family where it is important to maintain appropriate intra-
family relativity. Historically, we have frequently utilized an
incremental methodology in which we value a code based upon its
incremental difference between another code or another family of codes.
We note that the RUC has also used the same incremental methodology on
occasion when it was unable to produce valid survey data for a service.
We are finalizing our work RVUs for this family as proposed.
(8) Percutaneous Arteriovenous Fistula Creation (CPT Codes 36836 and
36837)
In October 2021, the CPT Editorial Panel created CPT codes 36836
(Percutaneous arteriovenous fistula creation, upper extremity, single
access
[[Page 69486]]
of both the peripheral artery and peripheral vein, including fistula
maturation procedures (e.g., transluminal balloon angioplasty, coil
embolization) when performed, including all vascular access, imaging
guidance and radiologic supervision and interpretation) and 36837
(Percutaneous arteriovenous fistula creation, upper extremity, separate
access sites of the peripheral artery and peripheral vein, including
fistula maturation procedures (e.g., transluminal balloon angioplasty,
coil embolization) when performed, including all vascular access,
imaging guidance and radiologic supervision and interpretation) to
describe the creation of an arteriovenous fistula in an upper extremity
via a percutaneous approach. Previously, CPT coding did not account for
percutaneous arteriovenous access creation, as current the CPT codes
only describe an open surgical approach. Given that new technologies
have been developed that allow for less invasive approaches that
utilize percutaneous image-guided methods to approximate a target
artery and vein using magnets or mechanical capture, we created HCPCS
codes G2170 (Percutaneous arteriovenous fistula creation (avf), direct,
any site, by tissue approximation using thermal resistance energy, and
secondary procedures to redirect blood flow (e.g., transluminal balloon
angioplasty, coil embolization) when performed, and includes all
imaging and radiologic guidance, supervision and interpretation, when
performed) and G2171 (Percutaneous arteriovenous fistula creation
(avf), direct, any site, using magnetic-guided arterial and venous
catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed) in July 2020 that describe two
approaches to percutaneous arteriovenous access creation. The RUC
intends for CPT codes 36836 and 36837, which represent two percutaneous
approaches to creating arteriovenous access for End-Stage Renal Disease
(ERSD) patients during hemodialysis, to replace HCPCS codes G2170 and
G2171, and has requested both G2170 and G2171 be deleted. For CY 2023,
the RUC recommended a work RVU of 7.50 for CPT code 36836, and a work
RVU of 9.60 for CPT code 36837.
We disagreed with the RUC-recommended RVUs for CPT codes 36836 and
36837. We found that the recommended work RVUs were high when compared
to other codes with similar time values. The RUC-recommended RVU of
7.50 for 36836 is the second highest RVU for codes with 55 to 65
minutes of intraservice time and 94 to 114 minutes of total time, with
RVUs ranging from 2.45 to 8.84. Similarly, the RUC-recommended RVU of
9.60 for 36837 is the third highest RVU for codes with 65 to 85 minutes
of intraservice time and 109 to 129 minutes of total time, with RVUs
ranging from 4.69 to 10.95. Therefore, we proposed a work RVU of 7.20
for CPT code 36836, and a work RVU of 9.30 for CPT code 36837.
We disagreed with the RUC-recommended work RVU of 7.50 for CPT code
36836 and proposed an RVU of 7.20 that is based on the intra-service
time ratio calculation using the second reference code from the RUC
survey, CPT code 36905 (Percutaneous transluminal mechanical
thrombectomy and/or infusion for thrombolysis, dialysis circuit, any
method, including all imaging and radiological supervision and
interpretation, diagnostic angiography, fluoroscopic guidance, catheter
placement(s), and intraprocedural pharmacological thrombolytic
injection(s); with transluminal balloon angioplasty, peripheral
dialysis segment, including all imaging and radiological supervision
and interpretation necessary to perform the angioplasty). The proposed
RVU of 7.20 is based on the intra-service time ratio using the RUC-
recommended 60 minutes intra-service time for CPT code 36836 divided by
75 minutes of intra-service time for CPT code 36905, then multiplying
by the RVU of 9.00 for CPT code 36905 ((60/75) x 9.00 = 7.20). We chose
to use the second reference code from the RUC survey, CPT code 36905,
in this calculation because its intra-service time and total time
values were closer to the time values proposed by the RUC for CPT code
36836. We noted that the RUC-recommended RVU of 7.50 is one of the
highest values within the range of reference codes we reviewed with the
same intra-service time and similar total time. The proposed work RVU
of 7.20 is supported by the reference CPT codes we compared to CPT code
36836 with the same 60 minutes of intra-service time and similar total
time as CPT code 36836; reference CPT code 47541 (Placement of access
through the biliary tree and into small bowel to assist with an
endoscopic biliary procedure (e.g., rendezvous procedure),
percutaneous, including diagnostic cholangiography when performed,
imaging guidance (e.g., ultrasound and/or fluoroscopy), and all
associated radiological supervision and interpretation, new access) has
a work RVU of 6.75, and reference CPT code 33991 (Insertion of
ventricular assist device, percutaneous, including radiological
supervision and interpretation; left heart, both arterial and venous
access, with transseptal puncture) has a work RVU of 8.84. Again, we
believe 7.20 is a more appropriate value overall than 7.50 when
compared to the range of codes with the same intra-service time and
similar total time.
Although we disagreed with the RUC-recommended work RVU of 9.60 for
CPT code 36837, we concur that the relative difference in work between
CPT codes 36836 and 36837 is equivalent to the RUC-recommended interval
of 2.10 RVUs. We believe the use of an incremental difference between
these CPT codes is a valid methodology for setting values, especially
in valuing services within a family of codes where it is important to
maintain an appropriate intra-family relativity. Therefore, we proposed
a work RVU of 9.30 for CPT code 36837, based on the RUC-recommended
interval of 2.10 RVUs above our proposed work RVU of 7.20 for CPT code
36836.
For the direct PE inputs, we solicited additional information on
two equipment items and four supply items. For two of those four supply
items, we requested a justification for their inclusion as direct PE
inputs. The RUC submitted invoices for two new equipment inputs; one
for a Wavelinq EndoAVF generator (EQ403) used for CPT code 36837, and
the other for an Ellipsys EndoAVF generator (EQ404) used for CPT code
36836. We solicited comments and requested information that may inform
us why the Wavelinq generator (EQ403) is so much more expensive on its
invoice as compared with the Ellipsys generator (EQ404) since the
former costs $18,580 and the latter costs $3,000.
In addition, the RUC included supply items SD149 (catheter, balloon
inflation device) and SD152 (catheter, balloon, PTA) as direct PE
inputs for CPT codes 36836 and 36837. We solicited comments and
requested information that may inform us if supply items SD149 and
SD152 are typical, and how often they are used, for CPT codes 36836 and
36837. Also, the RUC included supply items SF056 (detachable coil) and
SF057 (non-detachable embolization coil) as direct PE inputs for CPT
code 36837 (one each for SF056 and two each for SF057). We solicited
comments and requested
[[Page 69487]]
information that may provide us with a justification for keeping supply
items SF056 and SF057 as direct PE inputs for CPT code 36837. We need
to know if both of these supply items are typical and how often they
are used for CPT code 36837. If these supply inputs are not typical for
these procedures, we believe that they should be removed from the
direct PE inputs.
We proposed to delete HCPCS codes G2170 and G2171 and replace them
with CPT codes 36836 and 36837 as recommended by the RUC.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters agreed with our proposal to delete HCPCS
codes G2170 and G2171, and replace them with CPT codes 36836 and 36837.
One of the commenters also stated that they preferred CMS setting the
rates for percutaneous creation of an arteriovenous fistula through
rulemaking, rather than relying on contractor pricing. Other commenters
stated that the contractor-priced payments for HCPCS codes G2170 and
G2171 varied widely among the different Medicare Administrative
Contractors (MACs), ranging approximately from $6,100 to $12,000
(rounded).
Response: We thank the commenters for their support. We are
finalizing our proposal to delete HCPCS codes G2170 and G2171, and
replacing them with CPT codes 36836 and 36837. We are establishing the
RVUs for CPT codes 36836 and 36837 in this final rule, so the payments
for these codes will not be contractor-priced, in contrast to the
payments for HCPCS codes G2170 and G2171.
Comment: Several commenters disagreed with our proposed RVU of 7.20
for CPT code 36836 and RVU of 9.30 for CPT code 36837. Several
commenters also disagreed with our methodologies for the valuation of
the proposed RVUs and stated they do not appropriately reflect the
complexity and intensity of physician work associated with these
services. Therefore, they post that the statutorily-required intensity
component of the work RVU and its role in the valuation of these
procedures was overlooked. The commenters preferred that we accept the
RUC-recommended RVU of 7.50 for CPT code 36836 and RVU of 9.60 for CPT
code 36837 instead. The commenters stated that the proposed RVU is
unworkable given the time it takes to perform these procedures and PE
involved and that CMS's proposed RVU will cause barriers to patient
access to these procedures, and will have a disproportionate impact on
patients from underrepresented minority groups. However, there was one
commenter that stated even the RUC-recommended RVU of 9.60 for CPT code
36837 was too low. Many commenters stated that CMS is using flawed
methodologies for the valuation of codes for 2023, such as the building
block methodology, incremental methodology, code comparisons, and time
ratio methodology. This includes the intra-service time ratio
calculation that informs the proposed work RVU of 7.20 for CPT code
36836 and the incremental methodology used for the proposed RVU of 9.30
for CPT code 36837. Also, the commenters stated that CMS did not
provide any rationale or transparency as to how they arrived at the
reductions applied to CPT codes 36836 and 36837. The commenters stated
that CMS proposes an inconstant combination of inputs to apply, and
that this selection process has the appearance of seeking an arbitrary
value from the vast array of possible mathematical calculations, rather
than seeking a valid, clinically relevant relationship that would
preserve relativity between codes.
Response: We continue to believe that the RVU of 7.20 for CPT code
36836, and the RVU of 9.30 for CPT code 36837, are appropriate RVUs for
these procedures. We found that the RUC-recommended work RVUs were high
for these codes when compared to other codes with similar time values.
The RUC-recommended RVU of 7.50 for 36836 is the second highest RVU for
codes with 55 to 65 minutes of intraservice time and 94 to 114 minutes
of total time, with RVUs ranging from 2.45 to 8.84. Similarly, the RUC-
recommended RVU of 9.60 for 36837 is the third highest RVU for codes
with 65 to 85 minutes of intraservice time and 109 to 129 minutes of
total time, with RVUs ranging from 4.69 to 10.95.
We disagreed with the RUC-recommended work RVU of 7.50 for CPT code
36836 and proposed an RVU of 7.20 that is based on the intra-service
time ratio calculation using the second reference code from the RUC
survey, CPT code 36905. In our effort to remain transparent, we
provided the following rationale: The proposed RVU of 7.20 is based on
the intra-service time ratio using the RUC-recommended 60 minutes
intra-service time for CPT code 36836 divided by 75 minutes of intra-
service time for CPT code 36905, then multiplying by the RVU of 9.00
for CPT code 36905 ((60/75) x 9.00 = 7.20). We chose to use the second
reference code from the RUC survey, CPT code 36905, in this calculation
because its intra-service time and total time values were closer to the
time values proposed by the RUC for CPT code 36836. We noted that the
RUC-recommended RVU of 7.50 is one of the highest values within the
range of reference codes we reviewed with the same intra-service time
and similar total time. The proposed work RVU of 7.20 is supported by
the reference CPT codes we compared to CPT code 36836 with the same 60
minutes of intra-service time and similar total time as CPT code 36836;
reference CPT code 47541 has a work RVU of 6.75, and reference CPT code
33991 has a work RVU of 8.84. We continue to believe that the use of
time ratios is one of several appropriate methods for identifying
potential work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for information provided by surveys that suggests the amount of
time involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. When our review of recommended
values reveals that changes in the resource of time are not accounted
for in a RUC-recommended RVU, the obligation to account for that change
when establishing proposed and final work RVUs remains. We recognize
that it would not be appropriate to develop work RVUs solely based on
time given that intensity is also an element of work, but in applying
the time ratios, we are using derived intensity measures based on
current work RVUs for individual procedures. Were we to disregard
intensity altogether, the work RVUs for all services would be developed
based solely on time values and that is definitively not the case, as
indicated by the many services that share the same time values but have
different work RVUs. Furthermore, we reiterate that we use time ratios
to identify potentially appropriate work RVUs, and then use other
methods (including estimates of work from CMS medical personnel and
crosswalks to key reference or similar codes) to validate these RVUs.
For more details on our methodology for developing work RVUs, we direct
readers to the discussion CY 2017 PFS final rule (81 FR 80272 through
80277). Again, for CPT code 36836, we believe 7.20 is a more
appropriate value overall than 7.50 when compared to the range
[[Page 69488]]
of codes with the same intra-service time and similar total time.
For CPT code 36837, although we disagreed with the RUC-recommended
work RVU of 9.60, we did concur that the relative difference in work
between CPT codes 36836 and 36837 is equivalent to the recommended
interval of 2.10 RVUs. Therefore, we proposed a work RVU of 9.30 for
CPT code 36837, based on the recommended interval of 2.10 RVUs above
our proposed work RVU of 7.20 for CPT code 36836. We continue to
believe the use of an incremental difference between these CPT codes is
a valid methodology for setting values, especially in valuing services
within a family of codes where it is important to maintain an
appropriate intra-family relativity. Historically, we have frequently
utilized an incremental methodology in which we value a code based upon
its incremental difference between another code or another family of
codes. We note that the RUC has also used the same incremental
methodology on occasion when it was unable to produce valid survey data
for a service. Again, for CPT code 36837, we believe a work RVU of 9.30
based on an incremental increase of 2.10 RVUs above CPT code 36836 is a
more appropriate value than 9.60.
Comment: A few commenters stated that the proposed RVU of 7.20 for
CPT code 36836 and RVU of 9.30 for CPT code 36837 fall below the RUC
survey 25th percentile values of 7.50 and 9.60 respectively. Commenters
also stated that we need to provide a significant justification when we
propose an RVU that is below the 25th percentile.
Response: We remind the commenters that we used an intraservice
time ratio, described above, to develop the proposed RVU of 7.20 for
CPT code 36836, and that we used a 2.10 incremental increase from the
proposed RVU of 7.20 for CPT code 36836 for CPT code 36837, resulting
in an RVU of 9.30. The time ratio methodology and the incremental
methodology are both valid methodologies for developing the RVUs that
we propose, and there is no rule stating that the RVU cannot go below
the survey 25th percentile. In addition to the time ratio and
incremental methodologies, we also use other methods for developing
RVUs, such as the building block methodology and code comparisons. For
more details on our methodology for developing work RVUs, we direct
readers to the discussion CY 2017 PFS final rule (81 FR 80272 through
80277).
Comment: Several commenters responded to our request for additional
information for four direct PE supply items (SD149 (catheter, balloon
inflation device), SD152 (catheter, balloon, PTA), SF056 (detachable
coil), and SF057 (non-detachable embolization coil)) and two new direct
PE equipment items (EQ403 (Wavelinq EndoAVF generator) and EQ404
(Ellipsys EndoAVF generator)). Supply items SD149 and SD152 are direct
PE inputs for CPT codes 36836 and 36837, and supply items SF056 and
SF057 are direct PE inputs for CPT code 36837. Equipment item EQ403 is
a direct PE input for CPT code 36837, and equipment item EQ404 is a
direct PE input for CPT code 36836. For the four supply items, we had
requested a justification for their inclusion as direct PE inputs and
asked if these supply items are typical and how often they are used.
For the two new equipment items, we had requested information that may
inform us why the EQ403 is so much more expensive on its invoice as
compared with the EQ404, since the former costs $18,580 and the latter
costs $3,000.
Response: We thank the commenters for responding to our request for
information. The majority of commenters that responded to our request
for information stated that all four of these supply items are typical
and should be included as direct PE inputs for CPT codes 36836 and
36837 as recommended by the RUC. One commenter stated they believe the
typical direct PE input for CPT code 36837 is for one SF056 and that
SF057 is not a typical use, and also stated that they could not find
evidence of typical use (50 percent or greater) for supplies SD149 and
SD152 during CPT procedure code 36837.
A few commenters responded to our request for more information on
the costs for EQ403 and EQ404. The commenters stated that the specialty
societies submitted invoice pricing for supplies and equipment to the
RUC, and that they do not have any influence on the prices that vendors
set for their products. Some commenters described how each of these
equipment items are used. Another commenter stated that typically, the
WavelinQTM EndoAVF generator (E0403) can be acquired through
direct purchase or financed through an agreement where the provider
agrees to purchase a predetermined number of WavelinQTM
catheters (SD350). The price of the generator (EQ403) can change
depending on how many catheters the provider agrees to purchase and/or
the type of purchase agreement the provider chooses.
Again, we thank the commenters for responding to our request for
information. The majority of the commenters stated that PE supply items
SD149 and SD152 are typical direct PE inputs for CPT codes 36836 and
36837; and supply items SF056 and SF057 are typical direct PE inputs
for CPT code 36837. After reviewing the information provided by the
commenters, we are finalizing the direct PE supply items SD149, SD152,
SF056, and SF057 for CPT codes 36836 and 36837 as recommended by the
RUC without refinement. We are finalizing direct PE equipment items
EQ403 and EQ404 for CPT codes 36836 and 36837 as recommended by the RUC
without refinement.
Comment: One commenter was concerned that the proposed work RVU for
CPT code 36837 did not include the reimbursement for the coil
embolization supply items. The commenter stated that coil embolization
at the time of WavelinQ procedure is critical to the success of the
arteriovenous fistula. The commenter stated that embolization is a very
important step in the success of the procedure and should be taken into
account in the fee schedule.
Response: The work RVU is only for the activity of the physician
for a procedure code. Supply items SF056 (detachable coil) and SF057
(non-detachable embolization coil) are direct PE inputs for CPT code
36837, and the payment for these supply items is included in the PE
RVU. Therefore, the coil embolization supply items are reimbursed and
are taken into account in the physician fee schedule, though not in the
work RVU.
Comment: A few commenters requested that CMS separately identify
and pay for high-cost disposable supplies priced at more than $500
using appropriate HCPCS codes, instead of including these high-cost
supplies as direct PE inputs for CPT codes 36836 and 36837. These
supply items should then be reviewed annually and updated.
Response: We have received a number of prior requests from
interested parties, including the RUC, to implement separately billable
alpha-numeric Level II HCPCS codes to allow practitioners to be paid
the cost of high cost disposable supplies per patient encounter instead
of per CPT code. We stated at the time, and we continue to believe,
that this option presents a series of potential problems that we have
addressed previously in the context of the broader challenges regarding
our ability to price high cost disposable supply items. For a
discussion of this issue, we direct the reader to our discussion in the
CY 2011 PFS final rule with comment period (75 FR 73251).
Comment: One commenter submitted an additional invoice associated
with
[[Page 69489]]
the pricing of the EllipsysTM Vascular Access Catheter,
(SD351) supply. The commenter stated that Medtronic recently has been
compelled by rising costs to implement price increases across their
portfolio world-wide. Among the many contributing factors,
manufacturing labor costs have increased by nine percent, and key
materials that are used in making our products are exhibiting double-
digit cost increases. One commenter stated that starting in July of
2022, they revised their standard pricing for the EllipsysTM
catheter sold to physicians' offices to reflect rising costs and to
achieve parity with prices for catheters in other sites of service
(that is, hospital outpatient departments and ASCs). The commenter
stated that the price to physician office customers the
EllipsysTM catheter is now $8,950, and submitted an invoice
to support this assertion.
Response: We appreciate the submission of additional pricing
information this commenter for the SD351 supply. We note that the RUC
submitted invoices for this supply item with their recommendations
based on information gathered from the specialties that perform this
service. While we acknowledge that pricing for the item in question may
have changed, we are interested in additional review by other
interested parties before finalizing an increase in the price. The
submitted invoice would represent an increase from $6000 to $8950 for
the SD351 supply, an extraordinary increase in the span of 6 months
since the service was reviewed at the January 2022 RUC meeting. We will
review the valuations for this service when they are revised by the RUC
to reflect the additional costs described by this commenter, including
any increases in the price of the SD351 supply, and consider for future
updates to this service.
Comment: One commenter expressed concern that CMS is using only a
single invoice of $6,000 for SD351 (EllipsysTM Vascular
Access Catheter) and noted this pricing is unrepresentative for this
device. The commenter urged CMS to work with the manufacturers to
collect additional invoices to arrive at more appropriate pricing for
SD351.
Response: We often request that practitioners send us additional
invoices for supplies and equipment, which we then use to establish the
PE inputs and PE RVUs for specific services. We did receive an
additional invoice for SD351 but as noted above, the RUC submitted
invoices for this supply item with their recommendations based on
information gathered from the specialties that perform this service. We
will consider the additional invoice and this new information in future
rulemaking.
Comment: A few commenters stated that the direct PE inputs for
equipment for CPT code 36836 should reflect the use of EL011 (room,
angiography) rather than EL016 (room, ultrasound, vascular). One of
these commenters noted that although CPT code 36836 is done under
ultrasound, the typical location for this procedure is in an
angiography room given the angioplasty performed after the fistula
creation more than 90 percent of the time. Another commenter stated
that CMS' proposal to use an ultrasound room rather than an angiography
room in the development of the PE values for CPT code 36836 is
incorrect in their view, as CPT code 36836 typically infers inclusion
of a balloon angioplasty among the performed procedures, and in their
experience the appropriate venue when a balloon angioplasty is
performed is always an angiography room.
Response: We disagree with the commenters and believe that EL016
(room, ultrasound, vascular) is the appropriate direct PE equipment
input for CPT code 36836. We reviewed the equipment inputs on the
Practice Expense Summary of Recommendation for the non-facility
setting, and the PE spreadsheet, provided by the RUC for CPT codes
36836 and 36837. The RUC-recommended EL016 for CPT code 36836, and we
agree with the RUC recommendation. Please consider presenting any
direct PE equipment input changes for CPT code 36836 to the AMA RUC for
review.
After consideration of the public comments, we are finalizing the
work RVU values for the Percutaneous Arteriovenous Fistula Creation
code family (CPT codes 36836 and 36837) as proposed. We are finalizing
the direct PE inputs for CPT codes 36836 and 36837 without refinement.
Also, we are deleting HCPCS codes G2170 and G2171 as proposed.
(9) Energy Based Repair of Nasal Valve Collapse (CPT Codes 30468 and
30469)
In September 2021, the CPT Editorial Panel created CPT code 30469
(Repair of nasal valve collapse with low energy, temperature-controlled
(i.e., radiofrequency) subcutaneous/submucosal remodeling) which is
currently reported with an unlisted code. For the January 2022 RUC
meeting, both CPT code 30468 (Repair of nasal valve collapse with
subcutaneous/submucosal lateral wall implant(s)) and CPT code 30469
were reviewed. For CY 2023, the RUC recommended no change to the
current work RVU of 2.80 for CPT code 30468, and a work RVU of 2.70 for
CPT code 30469.
The RUC reviewed the specialty society request to affirm the recent
RUC valuations for CPT code 30468, which was surveyed and valued by the
RUC in January 2020 for CY 2021. The RUC agreed, so for CY 2023, the
RUC is not recommending any change to the current work RVU of 2.80 for
CPT code 30468. In addition, the PE Subcommittee reviewed the direct PE
inputs and made modifications to the pre-service clinical staff time to
CPT code 30468 in accordance with current standards. There was a
previous oversight in valuing the direct PE inputs for CPT code 30468.
Therefore, 3 minutes of clinical staff time has been added to CPT code
30468 for clinical activity CA005 (complete pre-procedure phone calls
and prescription).
We proposed to maintain the current work RVU of 2.80 for CPT code
30468 as recommended by the RUC. We also proposed the RUC-recommended
direct PE inputs for CPT code 30468, which now includes clinical
activity code CA005, without refinement.
For CPT code 30469, the RUC recommended a work RVU of 2.70 based on
a direct work RVU crosswalk from CPT code 31295 (Nasal/sinus endoscopy,
surgical, with dilation (e.g., balloon dilation); maxillary sinus
ostium, transnasal or via canine fossa). We disagreed with the RUC-
recommended work RVU of 2.70. Therefore, we proposed a work RVU of 2.44
for CPT code 30469, which is the same RVU as CPT code 31297 (Nasal/
sinus endoscopy, surgical, with dilation (e.g., balloon dilation);
sphenoid sinus ostium) and has the same 20 minutes of intra-service
time and similar total time. We noted that CPT code 31295, which the
RUC used as a direct crosswalk for the work RVU for CPT code 30469, has
the same 20 minutes of intra-service time and 56 minutes of total time
as CPT code 31297. We believe the RUC should have used CPT code 31297
as the crosswalk for CPT code 30469. Both CPT codes 31295 and 31297
were reviewed in 2017 and are in the same code family. The proposed
work RVU of 2.44 is supported by the reference CPT codes we compared to
CPT code 30469 with the same 20 minutes of intra-service time and
similar total time as CPT code 30469; reference CPT code 31233 (Nasal/
sinus endoscopy, diagnostic; with maxillary sinusoscopy (via inferior
meatus or canine fossa puncture)) with an RVU of 2.18, and CPT code
31295 with an RVU of 2.70. Again, we believe 2.44 is a more appropriate
value overall than 2.70
[[Page 69490]]
when compared to the range of codes with the same intra-service time
and similar total time.
We proposed the RUC-recommended direct PE inputs for CPT code 30469
without refinement.
The following is a summary of the comments we received and our
responses.
Comment: A few comments supported our proposal to maintain the
current work RVU of 2.80 for CPT code 30468.
Response: We thank the commenters for their support, and we are
finalizing the RUC-recommended RVU of 2.80 for CPT code 30468 as
proposed.
Comment: A few comments disagreed with our proposed work RVU of
2.44 for CPT code 30469. The commenters stated that we did not consider
the intensity for CPT code 30469, and that the intensity was a closer
match to the RUC-recommended crosswalk CPT code 31295, instead of our
proposed comparator code of CPT code 31297. One commenter stated that
CPT code 30469 has greater intensity because it involves multiple
applications in anatomic locations subject to damage which would worsen
the patient's condition. Also, commenters were concerned with
maintaining relativity between CPT codes 30468 and 30469, and also
stated that the proposed RVU of 2.44 for CPT code 30469 falls below the
survey 25th percentile for CPT code 30469.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another, and we still believe that CPT
code 31297 is a valid comparator to CPT code 30469, which has the same
20 minutes of intra-service time and similar total time as CPT code
30469. We also noted that CPT code 31295, which the RUC used as a
direct crosswalk for the work RVU for CPT code 30469, has the same 20
minutes of intra-service time and 56 minutes of total time as CPT code
31297. We do not agree with the commenter that we did not consider the
intensity for CPT code 30469, and would like to note that the intensity
represented by the IWPUT of 0.0853 for CPT code 32197 is similar to the
IWPUT of 0.0874 for the 2nd reference code used in the RUC survey,
which is CPT code 31238 (Nasal/sinus endoscopy, surgical; with control
of nasal hemorrhage). For relativity purposes, we note that there were
different codes with similar time values the RUC could have used
besides CPT code 31295. We continue to believe that the proposed work
RVU of 2.44 is supported by the reference CPT codes we compared to CPT
code 30469 with the same 20 minutes of intra-service time and similar
total time as CPT code 30469; reference CPT code 31233 with an RVU of
2.18, and CPT code 31295 with an RVU of 2.70. Also, we point out that
the RUC-recommended RVU of 2.70 was below the 25th percentile on two of
the three survey entries provided on the RUC Summary Report for CPT
code 30469, and that the lowest 25th percentile value for these three
entries was 2.25, which is below our proposed value of 2.44. Therefore,
we are finalizing the work RVU of 2.44 as proposed for CPT code 30469.
After consideration of the public comments, we are finalizing the
work RVUs for the Energy Based Repair of Nasal Valve Collapse code
family (CPT codes 30468 and 30469) as proposed. We are also finalizing
the direct PE inputs for codes 30468 and 30469 as proposed, without
refinement.
(10) Drug Induced Sleep Endoscopy (DISE) (CPT Code 42975)
In October 2020, the CPT Editorial Panel created CPT code 42975
(Drug-induced sleep endoscopy, with dynamic evaluation of velum,
pharynx, tongue base, and larynx for evaluation of sleep-disordered
breathing, flexible, diagnostic) to report drug induced sleep endoscopy
(DISE) flexible, diagnostic. At the January 2021 RUC Meeting, the RUC
requested that this service be resurveyed for the April 2021 RUC
Meeting using a standard 000-day survey template. For CY 2023, the RUC
recommended a work RVU of 1.95 for CPT code 42975.
We disagreed with the RUC-recommended work RVU of 1.95 for CPT code
42975 and proposed a work RVU of 1.58. We believe the RVU should be
lower than the RUC recommendation of 1.95 to reflect the decrease in
total time from 68 minutes to 50 minutes. The proposed RVU of 1.58 is
based on the total time ratio calculation using the RUC-recommended 50
minutes total time for CPT code 42975 divided by the 48 minutes of
total time for CPT code 43197 (Esophagoscopy, flexible, transnasal;
diagnostic, including collection of specimen(s) by brushing or washing,
when performed (separate procedure)), then multiplying by the RVU of
1.52 for CPT code 43197 ((50/48) x 1.52 = 1.58). We found that CPT code
43197 has the same intra-service time and similar total time as CPT
code 42975. Also, CPT code 43197 is a similar endoscopic procedure as
CPT codes 42975 and 31579 (Laryngoscopy, flexible or rigid telescopic,
with stroboscopy). We noted that CPT code 31579 is the first key
reference code in the RUC survey. The proposed work RVU of 1.58 is
supported by the reference CPT codes we compared to CPT code 42975 with
the same 15 minutes of intra-service time and similar total time as CPT
code 42975; reference CPT code 43200 (Esophagoscopy, flexible,
transoral; diagnostic, including collection of specimen(s) by brushing
or washing, when performed (separate procedure)) with an RVU of 1.42,
and CPT code 62272 (Spinal puncture, therapeutic, for drainage of
cerebrospinal fluid (by needle or catheter)) with an RVU of 1.58.
Again, we believe the proposed RVU of 1.58 is a more appropriate value
overall than 1.95 when compared to the range of codes with the same
intra-service time and similar total time.
We proposed the RUC-recommended direct PE inputs for CPT code 42975
without refinement.
The following is a summary of the comments we received and our
responses.
Comment: A few commenters disagreed with our proposed RVU of 1.58
for CPT code 42975, and want us to accept the RUC-recommended RVU of
1.95 instead. The commenters stated that they did not understand our
rationale that the RVU should be reduced due to the decrease in total
time between the two surveys for the January 2021 and April 2021 RUC
meetings, especially since an interim RVU of 1.90 was previously
accepted by CMS for the 2022 PFS. The commenters stated it is important
to note that the interim value accepted by CMS for the 2022 PFS was
based on inaccurate survey data, as the immediate post-service time was
not captured appropriately in the initial survey of CPT code 42975.
Upon resurvey, respondents gave identical intra time and post procedure
time. The only difference was the removal of 18 minutes of post time
(for the half day discharge management visit) that was included in
total time approved on an interim basis in January 2021, which
represents the reduction of total time from the January 2021 (68
minutes) to the April 2021 (50 minutes) total time for CPT code 42975.
Based on this, the commenters did not understand CMS' rationale that
the work RVU should be reduced due to the decrease in total time
between the two surveys, and argued that the first survey was
invalidated due to the use of the incorrect tool. Respondents therefore
were asked about post procedure visits/time, and indicated that a
discharge management visit occurs. The standard time for a half day
discharge management was then recommended by
[[Page 69491]]
one of the specialty societies. The only change in data for the April
survey was that respondents were not asked about a discharge management
visit, and therefore, they did not indicate that one occurred. Their
pre, intra, and immediate post times were almost identical. Therefore,
the commenters believe that the RUC-recommended RVU of 1.95 is
justified and is appropriate as compared to the key reference services
selected and the broader fee schedule of codes with similar times and
intensity.
Response: We appreciate the RUC resurveying CPT code 42975. This
allowed us to review CPT code 42975 again and revalue it for 2023. We
note that when CPT code 42975 was initially valued in January 2021, an
incorrect survey instrument was used, thus requiring CPT code 42975 to
be resurveyed in April 2021. In January 2021, the RUC questioned the 18
minutes for the \1/2\ discharge day management used by the specialty
society to value CPT code 42975, and determined that it was not
necessary for this code. When CPT code 42975 was resurveyed for the
April 2021 RUC meeting, the total time showed the decrease of 18
minutes due to the removal of the \1/2\ discharge day management. Thus,
the total time for CPT code 42975 dropped from 68 minutes to 50
minutes. Therefore, we continue to believe the RVU should be lower than
the RUC recommendation of 1.95 to reflect the decrease in total time
from 68 minutes to 50 minutes. The proposed RVU of 1.58 is based on the
total time ratio calculation using the RUC-recommended 50 minutes total
time for CPT code 42975 divided by the 48 minutes of total time for CPT
code 43197, then multiplying by the RVU of 1.52 for CPT code 43197
((50/48) x 1.52 = 1.58). We found that CPT code 43197 has the same
intra-service time and similar total time as CPT code 42975. Also, CPT
code 43197 is a similar endoscopic procedure as CPT codes 42975 and
31579. We noted that CPT code 31579 is the first key reference code in
the RUC survey. The proposed work RVU of 1.58 is supported by the
reference CPT codes we compared to CPT code 42975 with the same 15
minutes of intra-service time and similar total time as CPT code 42975;
reference CPT code 43200 with an RVU of 1.42, and CPT code 62272 with
an RVU of 1.58. Again, we continue to believe the proposed RVU of 1.58
is a more appropriate value overall than 1.95 when compared to the
range of codes with the same intra-service time and similar total time.
Therefore, we are finalizing the work RVU of 1.58 for code 42975 as
proposed.
Comment: One commenter disagreed with our use of a total time ratio
to develop the proposed RVU of 1.58 for CPT code 42975, and stated that
it neglects to capture the level of intensity. The commenter stated
that the methodologies CMS used for the valuation of specific codes for
2023 is flawed, including the total time ratio calculation that informs
the proposed work RVU of 1.58 for CPT code 42975.
Response: We disagree with the commenter and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
In accordance with the statute, we believe that changes in time and
intensity must be accounted for when developing work RVUs. When our
review of recommended values reveals that changes in the resource of
time are not accounted for in a RUC-recommended RVU, the obligation to
account for that change when establishing the proposed and final work
RVUs remains. We recognize that it would not be appropriate to develop
work RVUs solely based on time given that intensity is also an element
of work, but in applying the time ratios, we are using derived
intensity measures based on current work RVUs for individual
procedures. Were we to disregard intensity altogether, the work RVUs
for all services would be developed based solely on time values and
that is definitively not the case, as indicated by the many services
that share the same time values but have different work RVUs.
Furthermore, we reiterate that we use time ratios to identify
potentially appropriate work RVUs, and then use other methods
(including estimates of work from CMS medical personnel and crosswalks
to key reference or similar codes) to validate these RVUs. For more
details on our methodology for developing work RVUs, we direct readers
to the discussion in the CY 2017 PFS final rule (81 FR 80272 through
80277).
Comment: One commenter stated that the proposed RVU of 1.58 for CPT
code 42975 falls below the RUC survey 25th percentile of 1.95, and that
we need to provide a significant justification when we propose an RVU
that is below the 25th percentile.
Response: We disagree with the commenter and would like to remind
the commenter that we used a total time ratio, described above, to
develop the proposed RVU of 1.58 for CPT code 42975. A total time ratio
is one of several valid methodologies we use for developing the RVUs
that we propose, and there is no rule stating that the work RVU cannot
go below the survey 25th percentile. We believe that changes in work
time should be reflected in changes to the work RVU, and note that the
total time decreased for CPT code 42975 when it was resurveyed in April
2021.
After consideration of the public comments, we are finalizing the
work RVU for the Drug Induced Sleep Endoscopy (DISE) code family (CPT
code 42975) as proposed. We are finalizing the direct PE inputs for
code 42975 as proposed, without refinement.
(11) Endoscopic Bariatric Device Procedures (CPT Codes 43235, 43290,
and 43291)
In February 2021, the CPT Editorial Panel created CPT codes 43290
(Esophagogastroduodenoscopy, flexible, transoral; with deployment of
intragastric bariatric balloon) and 43291 (Esophagogastroduodenoscopy,
flexible, transoral; with removal of intragastric bariatric balloon(s))
for endoscopic bariatric device procedures to the
esophagogastroduodenoscopy (EGD) code family. CPT code 43235
(Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing, when performed
(separate procedure)) is the base code for the EGD family and was
surveyed with the new endoscopic bariatric device procedures, 43290 and
43291. All three of these CPT codes were reviewed at the April 2021 RUC
meeting. For CY 2023, the RUC recommended an RVU of 3.11 for CPT code
43290, an RVU of 2.80 for CPT code 43291, and maintaining the current
work RVU of 2.09 for CPT code 43235.
We proposed the RUC-recommended work RVU of 3.11 for CPT code
43290, the RUC-recommended work RVU of 2.80 for CPT code 43291, and
maintaining the current work RVU of 2.09 for CPT code 43235 for this
code family.
We proposed the direct PE inputs for CPT code 43235 without
refinement. However, we proposed refinements to the direct PE inputs
for CPT codes 43290 and 43291.
For CPT code 43290, we proposed refinements to the direct PE inputs
for
[[Page 69492]]
clinical labor activity codes CA001 (complete pre-service diagnostic
and referral forms) and CA011 (provide education/obtain consent). We
proposed to refine CA001 from 5 minutes to the standard 3 minutes since
no explanation was provided to support 5 minutes for this clinical
labor activity. We proposed to refine CA011 from 15 minutes to 10
minutes since it was not clear why this much time for education is
needed, and we do not believe that the recommended 15 minutes would be
typical for the procedure. Also, when we looked at other procedures
with clinical labor activity code CA011 we did not find many procedures
with more than 12 minutes for this activity. Therefore, we proposed to
refine the clinical labor activity times for CA001 and CA011 for CPT
code 43290 as described above, and to accept the remaining RUC-
recommended direct PE inputs without refinement.
For CPT code 43291, we proposed a refinement to the direct PE input
for clinical labor activity code CA016 (prepare, set-up and start IV,
initial positioning and monitoring of patient) from 10 minutes to the
standard 2 minutes. In the PE Summary of Recommendations for non-
facility direct PE inputs provided by the RUC, the RUC recommended 8
minutes above the standard 2 minutes for CA016 and stated this clinical
labor activity was identical to the 10 minutes for positioning the
patient as CPT code 43260 (Endoscopic retrograde
cholangiopancreatography (ERCP); diagnostic, including collection of
specimen(s) by brushing or washing, when performed (separate
procedure)). However, our study of this code family could not find 10
minutes of non-facility direct PE inputs for clinical labor activity
CA016. Also, CPT code 43260 is only performed in a facility and does
not have any non-facility clinical labor times. Therefore, we proposed
to refine the clinical labor activity time for CA016 for CPT code 43291
as described above, and to accept the remaining RUC-recommended direct
PE inputs without refinement. This proposed reduction of 8 minutes to
the CA016 clinical labor activity also carried over to the equipment
times for the suction machine (Gomco) (EQ235), the scope video system
(monitor, processor, digital capture, cart, printer, LED light)
(ES031), and the multi-channeled flexible digital scope, esophagoscopy
gastroscopy duodenoscopy (EGD) (ES087) which we proposed to reduce by
the same 8 minutes.
The following is a summary of the comments we received and our
responses.
We did not receive comments on the proposed work RVUs for CPT codes
43235, 43290, and 43291. Therefore, we are finalizing the work RVU of
2.09 for CPT code 43235, the RVU of 3.11 for code 43290, and the RVU of
2.80 for code 43291 as proposed. We did receive comments on the direct
PE inputs for CPT codes 43290 and 43291, and those comments and
responses are below.
Comment: We received a few comments regarding the PE inputs for CPT
code 43290 in the non-facility setting. The commenters requested that
we accept the RUC-recommended clinical labor times for CA001 and CA011
in the non-facility setting. The commenters stated that the RUC agreed
that the ``Extensive Use of Clinical Staff'' package should be used for
CA001 to allow 5 minutes for CPT code 43290. Also, the commenters
stated that additional minutes above the standard for CA011 were needed
for CPT code 43290 due to the extent of the patient instruction
required, and stated 15 minutes should be allowed.
Response: We continue to disagree with the RUC-recommended direct
PE inputs for clinical labor activity codes CA001 and CA011 for CPT
code 43290. We reviewed the Practice Expense Summary of Recommendation
for the facility and non-facility settings. We continue to believe that
3 minutes for CA001, and 10 minutes for CA011, in the non-facility
setting is appropriate. Although the RUC recommended 5 minutes for
CA001 in the non-facility setting, we note that that the RUC
recommended only 3 minutes for CA001 in the facility setting, and not
the 5 minutes that would be the standard for the ``Extensive Use of
Clinical Staff'' in the facility and non-facility settings. After
reviewing the comments, we are still not convinced that the information
provided would support the need for 5 minutes for CA001 in the non-
facility setting. Also, for clinical labor activity CA011, we continue
to believe that 10 minutes is appropriate and that the recommended 15
minutes would not be typical for the procedure. When we looked at other
procedures with clinical labor activity code CA011, we did not find
many procedures with more than 12 minutes for this activity. After
reviewing the comments, we remain unconvinced that the information
provided would support the need for 15 minutes for CA011 in the non-
facility setting. Therefore, we are finalizing the clinical labor
activity times for CA001 and CA011 for CPT code 43290 as proposed.
Comment: The commenters stated that 10 minutes was needed for CA016
for CPT code 43291, instead of the standard 2 minutes, for positioning
the patient because no other procedure in this code family is performed
in this position, which is why extra time is required. The commenters
stated that clinical labor time needed to position the patient is
identical to that of CPT code 43260 and described the process as
follows: patient is placed face up with their head resting on a pad
positioner or pillow and their neck in a neutral position, patient's
arms are positioned to maintain a neutral thumb-up or supinated
position and may be tucked at their sides or abducted to less than 90
degrees on arm boards, then the patient is intubated while supine and
staff must then move the patient into left lateral position.
Response: After reviewing the comments, we are still not convinced
that the information provided would support the need for 10 minutes for
CA016 for CPT code 43291. We continue to believe that the standard 2
minutes for CA016 is appropriate. We remind the commenters that in our
study of CPT code 43260, we could not find 10 minutes of non-facility
direct PE inputs for clinical labor activity CA016 as suggested. Also,
we remind the commenters that CPT code 43260 is only performed in the
facility setting and does not have any non-facility clinical labor
times. Therefore, we are finalizing the clinical labor activity time
for CA016 for CPT code 43291 as proposed.
After consideration of the public comments, we are finalizing the
work RVU values for the Endoscopic Bariatric Device Procedures code
family (CPT codes 43235, 43290, and 43291) as proposed. We are
finalizing the direct PE inputs for CPT code 43235 as proposed, without
refinement. We are finalizing the direct PE inputs for CPT codes 43290
and 43291 as proposed.
(12) Delayed Creation Exit Site From Embedded Catheter (CPT Code 49436)
CPT code 49436 (Delayed creation of exit site from embedded
subcutaneous segment of intraperitoneal cannula or catheter) was
finalized as potentially misvalued in the CY 2022 PFS final rule (86 FR
64996) and the code was found to be appropriate to value for the non-
facility/office setting. The RUC only reviewed the PE inputs for this
service at the January 2022 meeting. The RUC recommended 5 minutes for
Clinical Activity Code CA013, line 34 in the non-facility/office
setting on the RUC-recommended PE spreadsheet. We disagreed with the
RUC-recommended
[[Page 69493]]
time, and proposed the standard time of 2 minutes, as an adequate
rationale was not provided for the additional time in the global space.
The proposed reduction of 3 minutes to the CA013 clinical labor
activity also carries over to the equipment times, which we proposed to
reduce by the same 3 minutes. Otherwise, we agreed with the RUC-
recommended clinical labor times for activity codes CA011 and CA018,
and we proposed the remaining refinements as recommended.
The RUC did not recommend any work inputs for this code and we did
not propose any work RVU refinements.
We received three comments regarding our proposed direct PE input
refinements for CPT code 49436 in response to the CY 2023 PFS proposed
rule and those comments are summarized below.
Comment: Two commenters stated that the rationale for the
additional 3 minutes under the CA013 clinical labor activity was
included in the PE Summary of Recommendations (SOR), which lists the
supply items needed to set up the procedure room. The commenters stated
that the 36 supply items are mostly sterile and will take at least 3
more minutes to set up than the standard 2 minutes allocated for an E/M
service. Another commenter requested that we reevaluate and finalize
the RUC-recommended 5 minutes.
Response: We continue to disagree with the RUC-recommended 5
minutes for Clinical Activity Code CA013. The PE SOR did not provide a
sufficient rationale for the additional time, and commenters did not
provide new data to justify the additional time. This procedure is
performed during an office visit, and we believe that the standard 2
minutes adequately accounts for the preparation of supplies, when
compared to similar codes in the global space and non-facility/office
setting.
After consideration of the public comments, we are finalizing 2
minutes for CA013 as proposed. The proposed reduction of 3 minutes to
the CA013 clinical labor activity also carries over to the formula used
to calculate equipment times, which we are finalizing to reduce by the
same 3 minutes. We agreed with the RUC-recommended clinical labor times
for activity codes CA011 and CA018, and we are finalizing the remaining
refinements as proposed and recommended.
(13) Percutaneous Nephrolithotomy (CPT Codes 50080 and 50081)
In September 2021, the CPT Editorial Panel revised the descriptors
to CPT codes 50080 (Percutaneous nephrolithotomy or pyelolithotomy,
lithotripsy stone extraction, antegrade ureteroscopy, antegrade stent
placement and nephrostomy tube placement, when performed, including
imaging guidance; simple (e.g., stone[s] up to 2 cm in a single
location of kidney or renal pelvis, nonbranching stones)) and 50081
(Percutaneous nephrolithotomy or pyelolithotomy, lithotripsy stone
extraction, antegrade ureteroscopy, antegrade stent placement and
nephrostomy tube placement, when performed, including imaging guidance;
complex (e.g., stone[s] 2 cm, branching stones, stones in
multiple locations, ureter stones, complicated anatomy)), that in
recent claims data were identified via the site of service anomaly
screen, to be performed less than 50 percent of the time in the
inpatient setting, but both codes have 090 day global periods, which
include post-op inpatient hospital E/M services as a component of their
value, typical of major surgery codes. The revised code descriptors
also include image guidance and nephrostomy tube placement, which were
not present in the old descriptors, and were reported as procedures
that were separate from CPT codes 50081 and 50082. These codes have not
been reviewed for nearly 30 years.
CPT code 50080 currently has a work RVU of 15.74 with 117 minutes
of intra-service time and 359.5 minutes of total time. The RUC
recommended a work RVU of 13.50, 90 minutes of intra-service time, and
244 minutes of total time for CPT code 50080, which represents a
reduction from the current values. However, the recommended intra-
service times dropped by 76.9 percent from the current intra-service
time and the RUC recommended work RVU is reduced only by 85.9 percent.
Therefore, we disagree with the RUC recommended work RVU and we
proposed a work RVU of 12.11 for CPT code 50080 with the RUC
recommended 90 minutes of intra-service time and 244 minutes of total
time. We noted that our proposed work RVU for CPT code 50080 falls
between CPT code 36830 (Creation of arteriovenous fistula by other than
direct arteriovenous anastomosis (separate procedure); nonautogenous
graft (e.g., biological collagen, thermoplastic graft)), with a work
RVU of 12.03 and the same intra-service time of 90 minutes, and CPT
code 36818 (Arteriovenous anastomosis, open; by upper arm cephalic vein
transposition), with a work RVU of 12.39 and the same intra-service
time of 90 minutes (and both with similar total times to CPT code
50080).
CPT code 50081 currently has a work RVU of 23.50 with 42 minutes of
pre-service evaluation time, 0 minutes of pre-service positioning time,
25 minutes of pre-service scrub/dress/wait time, 195 minutes of intra-
service time, 27 minutes of immediate post-service time, and 507.5
minutes of total time. The RUC recommended 22.00 work RVUs with 40
minutes of pre-service evaluation time, 3 minutes positioning time, 10
minutes scrub/dress/wait time, 140 minutes of intra-service time, 44
minutes of immediate post-service time, for a sum of 302 minutes of
total time. The RUC-recommended intra-service time and total time for
CPT code 50081 are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs. Though
the RUC recommended a work RVU of 22.00 that is less than the current
23.50 work RVU, a substantial reduction in time should be better
reflected in the work RVU.
The RUC recommended 13.50 work RVUs for CPT code 50800 and 22.00
for CPT code 50081, with an incremental difference between the two
codes of 8.50 work RVUs (22.00 - 13.50 = 8.50). We proposed a work RVU
of 20.61 for CPT code 50081, based on the proposed CPT code 50080's
work RVU of 12.11 plus the RUC-recommended incremental difference 8.50
work RVUs between CPT code 50080 and CPT code 50081(12.11 + 8.50 =
20.61).
We proposed the direct PE inputs as recommended by the RUC for both
codes in the family.
Comment: We received several comments concerning CPT codes 50080
and 50081, all opposing our proposed work RVUs for these services.
Commenters pointed out that CPT codes 50080 and 50081 are not the same
services that they were when they were last reviewed. They noted that
both codes have retained their current work RVUs since CY 2010 and that
they now encompass several other procedures that previously could have
been separately billable, which has increased their intensity and
complexity. These additions include imaging supervision and
interpretation, antegrade stent placement, nephrostomy tube placement
and antegrade ureteroscopy as have been included in their new
descriptors.
Response: We acknowledge that it has been many years since these
two CPT codes were last reviewed and percutaneous nephrolithotomy's
technologies and methodologies have changed, which may have added
complexities to the service, but at the same time, there have been
improvements in methods and
[[Page 69494]]
efficiencies through research and evaluations of better and best
practices. We see evidence of this just in the change in the physician
intra-services times for CPT code 50080 with what was 117 minutes, but
is now 90 minutes, even with the addition of those services now added
to the new descriptor (compared to the previous descriptor for CPT code
50080; Percutaneous nephrostolithotomy or pyelostolithotomy, with or
without dilation, endoscopy, lithotripsy, stenting, or basket
extraction; up to 2 cm.). Similarly, with the change in the physician
intra-services times for CPT code 50081 with what was 195 minutes, but
is now 140 minutes, even with the addition of those services now added
to the new descriptor (compared to the previous descriptor for CPT code
50081; Percutaneous nephrostolithotomy or pyelostolithotomy, with or
without dilation, endoscopy, lithotripsy, stenting, or basket
extraction; over 2 cm). The skills and trainings of the physicians have
certainly become more efficient in performing the main task and the
additional tasks now bundled into CPT codes 50080 and 50081 using less
intra-service time and total time for these procedures.
Comment: Commenters suggested that CMS should consider CPT codes
50080 and 50081 as entirely new codes with their new descriptors
describing their bundling and that the old codes are not really
comparable to all of the tasks performed in the new code and thus CMS
should place more weight in the most recent results from these codes'
surveyed work RVUs and their surveyed times, specifically the 25th
percentile results.
Response: We do agree that the new descriptors for CPT codes 50080
and 50081 are more detailed and more specific about what is now bundled
in with the entirety of the service but the fundamental core of these
services are still the same and they are not completely new and
different enough to make them incomparable. We still believe that the
reductions in physician work times should generally result in
reductions in of the work RVUs, as we have proposed. If those
additional tasks of imaging supervision and interpretation, antegrade
stent placement, nephrostomy tube placement and antegrade ureteroscopy
were separately paid from CPT codes 50080 and 50081, those separate
claim codes and their typical units of service were not included in the
AMA RUC recommendations for consideration to value the bundled service.
Having those CPT codes, their work RVUs, and their intra-service
minutes would have been useful when we were valuing these services.
Commenters reiterated that these services, these additional tasks, are
now part of the bundled codes, which lead us to re-review the AMA RUC
recommendations. From our re-review of the AMA RUC recommendations, we
do note that in the text material accompanying the RUC recommendation
for CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour
physician or other qualified health care professional time) codes or
language was struck from the text material. It is unclear if the
reference to CPT code 76000 was intentionally deleted, but we note that
CPT code 76000 has a work RVU value of 0.30 and an intra-service time
of 10.0 minutes and a total time of 20.0 minutes.
Comment: Commenters objected to CMS' selection of comparator codes.
Commenters stated that the comparator codes chosen by CMS (for CPT code
50080 which falls between CPT codes 36830 and 36818) do not have
similar clinical anatomical basis to CPT codes 50080 and 50081, and
that our comparator codes have not taken into account similar levels of
work intensities.
Response: We believe our selected comparator codes are relevant in
the PFS relative value system and that all services are appropriately
subject for comparison to each other. By statute, we are required to
consider times and intensities as they are related to work when
reviewing and valuating all CPT and HCPCS services.
After review and consideration of all comments on our proposals for
CPT codes 50080 and 50081, we believe that the value of CPT code 76000
is not entirely accounted for in our original proposed valuations and
we are adding Fluoroscopy's 0.30 work RVUs to both CPT codes 50080 and
50081, since this work was omitted from our proposed valuations. We are
finalizing 12.41 work RVUs (12.11 + 0.30) for CPT code 50080 and 20.91
work RVUs (12.11 + 8.50 + 0.30) for CPT code 50081 for CY 2023. We are
also finalizing the direct PE inputs as proposed and as recommended by
the RUC for both of these codes.
(14) Laparoscopic Simple Prostatectomy (CPT Codes 55821, 55831, 55866,
and 55867)
In October 2021, the CPT Editorial Panel added CPT placeholder code
55867 (Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) and prompted this family of
Laparoscopic Simple Prostatectomy codes for survey and review for the
January 2022 RUC meeting.
The RUC recommended a work RVU of 15.18 for CPT code 55821
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); suprapubic, subtotal, 1 or 2 stages) with 33 minutes of
pre-service evaluation time, 3 minutes positioning time, 10 minutes
scrub/dress/wait time, 120 minutes of intra-service time, and 25
minutes of immediate post-service time, for a sum of 329 minutes of
total time. CPT code 55821 currently has a work RVU value of 15.76 with
102.0 minutes of intra-service time and 399.5 minutes of total time.
After reviewing this code and relative similar codes in the PFS, we
proposed the RUC-recommended work RVU of 15.18 with 315 minutes of
total time.
The RUC recommended a work RVU of 15.60 for CPT code 55831
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); retropubic, subtotal), with 40 minutes of pre-service
evaluation time, 3 minutes positioning time, 10 minutes scrub/dress/
wait time, 120 minutes of intra-service time, 25 minutes of immediate
post-service time, for a sum of 329 minutes of total time. CPT code
55831 currently has a work RVU value of 17.19 with 114.0 minutes of
intra-service time and 422.5 minutes of total time. The RUC notes an
additional degree of difficulty with this retropubic incision approach
(behind the pubis) compared to the suprapubic approach. After reviewing
this code and relative similar codes in the PFS, we proposed the RUC
recommended work RVU of 15.60 with 322 minutes of total time.
The RUC recommended a work RVU of 22.46 for CPT code 55866
(Laparoscopy, surgical prostatectomy, retropubic radical, including
nerve sparing, includes robotic assistance, when performed) with 40
minutes of pre-service evaluation time, 15 minutes positioning time, 12
minutes scrub/dress/wait time, 180 minutes of intra-service time, 50
minutes of immediate post-service time, for a sum of 362 minutes of
total time. CPT code 55866 currently has a work RVU value of 26.80 with
180 minutes of intra-service time and 422 minutes of total time. The
RUC notes that this procedure removes the entire prostate with robotic
assistance, and the complexity of nerve sparing when operating with a
cancerous
[[Page 69495]]
prostate, increases the medical complexity and intensity of this
procedure. After reviewing this code and relative similar codes in the
PFS, we proposed the RUC recommended work RVU of 22.46 with 362 minutes
of total time to CPT code 55866.
The RUC recommended a work RVU of 19.53 for CPT code 55867
(Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) with 40 minutes of pre-service
evaluation time, 8 minutes positioning time, 11 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 50 minutes of immediate
post-service time, for a sum of 354 minutes of total time. The RUC
offers CPT code 42420 (Excision of parotid tumor or parotid gland;
total, with dissection and preservation of facial nerve) with a work
RVU of 19.53, 180 minutes of intra-service time and 383 minutes of
total time)) as a crosswalk to CPT code 55867. After reviewing this
code and relative similar codes in the PFS, we proposed the RUC-
recommended work RVU of 19.53 with 354 minutes of total time to CPT
code 55867.
We proposed the RUC-recommended direct PE inputs for CPT codes
55821, 55831, 55866, and 55867 without refinement.
CMS received two comments for CPT codes 55821, 55831, 55866, and
55867.
Comment: Both comments for these Laparoscopic Simple Prostatectomy
codes indicated support for CMS to accept the RUC-recommended work RVUs
and the direct PE inputs adjustments.
Response: We thank commenters for taking time to submit comments
expressing support for our proposals to accept the RUC-recommendations
for CPT codes 55821, 55831, 55866, and 55867.
We are finalizing the RUC-recommended work RVUs and direct PE
inputs for these Laparoscopic Simple Prostatectomy codes.
(15) Lumbar Laminotomy With Decompression (CPT Codes 63020, 63030, and
63035)
In October 2018, CPT code 63030 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, lumbar) was identified by the AMA as having an anomalous
site of service when compared to Medicare utilization data. The
Medicare data from 2014 through 2017 indicated that CPT code 63030 was
performed less than 50 percent of the time in the inpatient setting,
yet included inpatient hospital evaluation and management (E/M)
services within its global period. In January 2019, the RUC recommended
that this code be reviewed in 2 years (January 2021) to determine if
previous changes to differentiate percutaneous, endoscopic, and open
spine procedures were effective to correct reporting of this service.
In December 2020, the Relativity Assessment Workgroup noted that CPT
code 63030 continues to be primarily reported in the outpatient
setting, but still includes inpatient hospital visits in its valuation.
The specialty society indicated that there is still confusion about
this code, and therefore, the RUC recommended that CPT code 63030 be
referred to the CPT Editorial Panel to revise the descriptor to
mitigate the incorrect reporting in the outpatient setting, but the CPT
Editorial Panel did not accept the code change application to
differentiate inpatient (63030) versus outpatient (630X0) at the
September 2021 CPT meeting. Since this is a site of service issue, CPT
code 63030 was surveyed with the code family for the January 2022 RUC
meeting.
For CPT codes 63020 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, cervical), 63030, and 63035 (Laminotomy (hemilaminectomy),
with decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; each
additional interspace, cervical or lumbar (List separately in addition
to code for primary procedure)), we disagree with the RUC's recommended
work RVUs of 15.95, 13.18, and 4.00, respectively, because they do not
account for the surveyed changes in time for CPT codes 63020, 63030,
and 63035, and the full application of the 23-hour policy to CPT code
63030. We proposed a work RVU of 14.91 for CPT code 63020, a work RVU
of 12.00 for CPT code 63030, and a work RVU of 3.86 for CPT code 63035.
The RUC recommended 40 minutes pre-service evaluation, 20 minutes
pre-service positioning, 15 minutes pre-service scrub/dress/wait time,
90 minutes intraservice time, 30 minutes immediate post-service time,
and one CPT code 99232 (subsequent hospital care/day 25 minutes), one
CPT code 99231 (Subsequent hospital care/day 15 minutes), one CPT code
99238 (Hospital discharge day management; 30 minutes or less), one CPT
code 99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter.), and two CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits in the post-
operative period. This results in a 15-minute decrease in the pre-
service period, a 30-minute decrease in intraservice time, a 5-minute
decrease in immediate post-service time, and a 17-minute increase in
the post-operative period. The proposed work RVU of 14.91 is based on
the total time ratio calculation using the RUC-recommended 379 minutes
of total time divided by the current total time of 412 minutes for CPT
code 63020, then multiplying by the current work RVU of 16.20 for CPT
code 63020 ((379 minutes/412 minutes) * 16.20 = 14.90). We noted that
this is a direct crosswalk to CPT code 27057 (Decompression
fasciotomy(ies), pelvic (buttock) compartment(s) (e.g., gluteus medius-
minimus, gluteus maximus, iliopsoas, and/or tensor fascia lata muscle)
with debridement of nonviable muscle, unilateral), which has a work RVU
of 14.91, identical intraservice and immediate post-service time of 90
minutes and 30 minutes, respectively, and only 10 more minutes of total
time. We believe this work RVU more adequately accounts for the
decrease in total and intraservice time than the RUC recommended work
RVU, and we noted that we considered the reverse building block
methodology, which would result in a work RVU of 14.30, but we believed
that it decreased the valuation of CPT code 63020 too much, considering
the shift in post-operative work to include a longer, more intense
office/outpatient visit (CPT code 99214).
We disagree with the RUC-recommended work RVU for CPT code 63030.
More specifically, we disagree with the RUC recommended work RVU for
CPT code 63030 because the RUC did not completely apply the 23-hour
policy calculation (finalized in the CY 2011 PFS final rule (75 FR
73226)) in formulating its recommendations.
[[Page 69496]]
Additionally, we disagree with the RUC recommended work RVU for this
code for which the RUC considered the patient to be admitted during the
post-operative period because the RUC did not fully apply the 23-hour
policy when formulating their recommendations. As we noted in the CY
2011 PFS final rule (75 FR 73226), and as we discuss earlier in this
section of this final rule (``(1) Anterior Abdominal Hernia Repair (CPT
codes 15778, 49591, 49592, 49593, 49594, 49595, 49596, 49613, 49614,
49615, 49616, 49617, 49618, 49621, 49622, and 49623''), the work RVUs
for services that are typically performed in the outpatient setting and
require a hospital stay of less than 24 hours may in some cases involve
multiple overnight stays while the patient is still considered to be an
outpatient for purposes of Medicare payment. Because such services are
typically furnished in the outpatient setting, they should not be
valued to include inpatient post-operative E/M visits. The level of
discharge day management services included in the valuation of such
services should similarly not reflect an inpatient discharge and should
therefore be reduced. And finally, as discussed in CY 2011 rulemaking,
the intraservice time from the inpatient level E/M postoperative visit
should be reallocated to the immediate postservice time of the service.
The 23-hour policy calculation, when fully applied to the calculation
of a work RVU, is used to reduce the value of discharge day management
services, remove the inpatient E/M visits, and reallocate the
intraservice time to the immediate post-service period. We refer
readers to the 2011 PFS final rule (75 FR 73226) for an in-depth
explanation of the 23-hour policy.
For CPT code 63030, we believe the RUC only partially applied the
23-hour policy when it applied the policy to the immediate post service
time, but not to the calculation of the work RVU. Instead, we believe
the 23-hour policy should be fully applied to this code that describes
outpatient services for which there is an overnight stay during the
post-operative period, regardless of the number of nights that a
patient stays in the hospital. The services to which the 23-hour policy
is usually applied would typically involve a patient stay in a hospital
for less than 24 hours, which often means the patient may stay
overnight in the hospital. On occasion, the patient may stay in the
hospital longer than a single night; however, in both cases (one night
or more than one night), the patient is considered to be a hospital
outpatient, not an inpatient, for Medicare purposes. In short, we do
not believe that the work that is typically associated with an
inpatient service should be included in the work RVUs for the
outpatient services to which the 23-hour policy applies, especially
considering the previously discussed site of service anomaly for CPT
code 63030.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we are instead proposing a
work RVU of 12.00 for CPT code 63030.The steps are as follows:
Step (1): 13.18 - 0.64 * = 12.54.
Step (2): 12.54 - 0.76 ** = 11.78.
Step (3): 11.78 + (10 minutes x 0.0224) *** = 12.00 RVUs.
* Value associated with \1/2\ hospital discharge day management
service.
** Value associated with an inpatient hospital visit, CPT code
99231.
*** Value associated with the reallocated intraservice time
multiplied by the post-service intensity of the 23-hour stay code.
The RUC recommended the maintenance of the current work RVU of
13.18 because there was no change in intraservice time and the 37-
minute decrease in total time is largely due to the change in immediate
post-service time and post-operative period from the application of the
23-hour policy. We noted that the proposed work RVU of 12.00 is higher
than the other valuations that we considered, including the total time
ratio work RVU of 11.75 ((305 minutes/342 minutes) * 13.18 = 11.75) and
the reverse building block work RVU of 11.45. We noted that the
proposed work RVU of 12.00 is well-bracketed by two 90-minute
intraservice timed 090-day CPT codes 28725 (Arthrodesis; subtalar),
with a work RVU of 11.22, and 58720 (Salpingo-oophorectomy, complete or
partial, unilateral or bilateral (separate procedure)), with a work RVU
of 12.16.
We noted that, in the summary of recommendations (SOR) submitted to
CMS by the RUC, the specialty societies assert that the surveyed total
time would be the same as the current total time if the 23-hour policy
was not fully applied to the immediate post-service time and post-
operative period, with only a shift of work from facility to office,
but we noted that this is not true. The surveyed total time is 339
minutes, but the RUC recommended 40 minutes for the pre-service
evaluation time rather than the specialty societies' surveyed 45
minutes. If the RUC had recommended the survey times, with the pre-
service evaluation refinement, the reverse building block work RVU
would be 12.62, still less than the RUC-recommended work RVU of 13.18,
effectively accounting for the shift from facility to office post-
operative visits.
For CPT code 63035, we proposed a work RVU of 3.86 based on the
reverse building block methodology to account for the 11-minute
increase in intraservice time. We noted that this proposed value is
between the surveyed 25th percentile value of 3.50 and the RUC-
recommended work RVU of 4.00. We noted that the proposed work RVU is
well-bracketed by two 60-minute add-on CPT codes--CPT code 50706 and
63231. CPT code 50706 (Balloon dilation, ureteral stricture, including
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all
associated radiological supervision and interpretation (List separately
in addition to code for primary procedure)), has a work RVU of 3.80,
and CPT code 63621 (Stereotactic radiosurgery (particle beam, gamma
ray, or linear accelerator); each additional spinal lesion (List
separately in addition to code for primary procedure)), has a work RVU
of 4.00.
For the direct PE inputs, we proposed to remove the 125 minutes of
equipment time for EQ168 (light, exam) for CPT codes 63020 and 63030
because the RUC contested the typicality of its use to assess the wound
and remove staples. Because it is a standard piece of equipment in a
neurosurgeon and orthopedic exam room, and the RUC questioned its
typicality, we proposed 0 minutes for EQ168 for CPT codes 63020 and
63030.
We received several comments regarding our proposed work RVUs and
two comments regarding our proposed refinement to direct PE input EQ168
(light, exam) for CPT codes 63020, 63030, and 63035 in response to the
CY 2023 PFS proposed rule and those comments are summarized below.
Comment: Commenters urged CMS to use valid survey data to establish
work RVUs when possible, instead of a calculated value supported by
another code with no clinical relevancy. The commenters disagreed with
our proposed work RVU of 14.91 for CPT code 63020, stating that the RUC
recommended the survey 25th percentile work RVU using magnitude
estimation from a valid survey of physicians who perform this service
and that it appropriately accounts for the decrease in intraservice
time, and therefore, it did not need to be decreased further.
Commenters also disagreed with the work RVU crosswalk from CPT code
27057 to CPT code 63020, stating that CPT code 27057 is a rarely
performed procedure for a significantly different patient population,
thus making it an
[[Page 69497]]
inappropriate comparison that discounts the time, work, and intensity
required to perform CPT code 63020. Commenters stated that CPT code
63020 requires removal of bone, along with dissection around nerve
roots and the spinal cord, whereas CPT code 27057 only requires the
soft tissue work of a fasciotomy. Commenters also stated that the
physician work described by CPT code 27057 does not entail the same
intensity of work required by CPT code 63020, does not include
significant risk of paralysis, and does not require routine use of
fluoroscopy and image guidance to perform the procedure. Commenters
stated that positioning for CPT code 63020 requires use of the Mayfield
headrest and is more complex than a routine prone positioning for CPT
code 27057. Commenters stated that CPT code 27057 includes gluteal
muscle debridement, which is tedious and time consuming, but not as
complex as work involving the resection of bone and retraction of
spinal nerves.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes that describe
clinically similar services are sometimes stronger comparator codes, we
do not agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate code
comparison or an appropriate crosswalk. As noted above, we proposed a
crosswalk to CPT code 27057 with the support of the total time ratio.
We believe that time ratios are a valid and appropriate tool for
determining work RVUs. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
In accordance with the statute, we believe that changes in time and
intensity must be accounted for when developing work RVUs. When our
review of recommended values reveals that changes in the resource of
time are not accounted for in a RUC-recommended RVU, the obligation to
account for that change when establishing proposed and final work RVUs
remains. For more details on our methodology for developing work RVUs,
we direct readers to the discussion on time ratios as discussed above
in this Valuation of Specific Codes section.
Regarding the commenters' assertion that the RUC-recommended work
RVU, which is only a decrease of 0.25 work RVUs from the current
valuation of CPT code 63020, accounts for the 15-minute decrease in the
pre-service period, a 30-minute decrease in intraservice time, a 5-
minute decrease in immediate post-service time, and a 17-minute
increase in the post-operative period, and did not need to be further
decreased, we reiterate that, although we do not imply that the
decrease in time as reflected in survey values must always equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity, absent an
obvious or explicitly stated rationale for why the relative intensity
of a given procedure has increased, it would be inappropriate to use
the RUC-recommended work RVU to value CPT code 63020 given the
significant decrease in intraservice time and the absence of an
adequate justification of increased intensity. The RUC-recommended work
RVU yields an IWPUT of 0.077, whereas the current IWPUT is 0.059. The
RUC-recommended work RVU would yield an IWPUT increase of 0.018 with no
obvious or explicitly stated rational for an increased intensity. If
the RUC's recommendations appear to disregard or dismiss the changes in
time, without a persuasive explanation of why such a change should not
be accounted for in the overall work of the service, then we generally
use one of the methodologies discussed above to identify potential work
RVUs, including the methodologies intended to account for the changes
in the resources involved in furnishing the procedure such as a total
time ratio.
We continue to believe our proposed work RVU of 14.91 for CPT code
63020 based on the total time ratio calculation and a direct crosswalk
to CPT code 27057, which has a work RVU of 14.91, identical
intraservice and immediate post-service time of 90 minutes and 30
minutes, respectively, and only 10 more minutes of total time, more
adequately accounts for the decrease in total and intraservice time
than the RUC recommended work RVU.
We note that while CPT code 63020 requires removal of bone, along
with dissection around nerve roots and the spinal cord whereas CPT code
27057 requires the soft tissue work of a fasciotomy, does not include
significant risk of paralysis, and does not require routine use of
fluoroscopy and image guidance to perform the procedure, CPT code
27057's vignette and service description describes a 75-year old female
who is febrile with leukocytosis who is taken to the operating room
emergently for fasciotomy(ies) and debridement of necrotic muscle. We
note that the typical patient is at risk of acute renal failure and
life-threatening rhabdomyolysis. We note that, while we understand that
the positioning for CPT code 63020 requires use of the Mayfield
headrest and is more complex than a routine prone positioning for CPT
code 27057, that difference is accounted for in the difference in pre-
service positioning time of 8 minutes, which has longstanding, well-
established standardized WPUT of 0.0224 which factors into the reverse
building block work RVU of 14.30. Therefore, we continue to believe a
direct crosswalk to CPT code 27057 is appropriate to value CPT code
63020 and are finalizing a work RVU of 14.91 for CPT code 63020.
Comment: The commenters disagreed with our proposed work RVU of
12.00 for CPT code 63030, stating that there is concern about
contradictory policies regarding the newly revised E/M CPT codes that
combined inpatient and observation (outpatient) services. They believe
this renders the 23-hour policy invalid.
Response: We believe that adopting the revisions for CPT codes
99221-99223 and 99231-99233 is not inconsistent with our 23-hour policy
as it applies to this code family. In this instance, we are reviewing
RUC-recommendations that explicitly identify CPT code 63030 as being
subject to our 23-hour policy. Consistent with discussions in the CY
2011 and CY 2022 PFS final rules cited above, we agree with the RUC
that this code is subject to the 23-hour policy, and we believe it is
appropriate to fully apply the 23-hour policy to CPT code 63030. We
note that we acknowledge commenters' concerns regarding policy
implications as a result of adopting the E/M inpatient/observation
revisions and will take that into consideration for future rulemaking.
Additionally, we note that we did not propose any changes to the
previously finalized 23-hour policy in the proposed rule, and we
believe it is still consistent to apply the 23-hour policy, as was
recommended by the RUC, for CPT code 63030. We also remind commenters
that the 23-hour policy calculation, when fully applied to the
calculation of a work RVU, is used to reduce the value of discharge day
management services, remove the inpatient E/M visits, and reallocate
the intraservice time to the immediate post-service period. We refer
readers to the 2011 PFS final rule (75 FR 73226) for an in-depth
explanation of the 23-hour policy. For CPT code 63030, we believe the
RUC only partially applied the 23-hour policy when it applied the
policy to the immediate post service time, but not to the calculation
of the work RVU. Instead, we continue to believe the 23-hour policy
should be fully applied to this code that describes
[[Page 69498]]
outpatient services for which there is an overnight stay during the
post-operative period, regardless of the number of nights that a
patient stays in the hospital. In short, we continue to believe that
the work that is typically associated with an inpatient service should
not be included in the work RVUs for the outpatient services to which
the 23-hour policy applies, especially considering the previously
discussed site of service anomaly for CPT code 63030. Therefore, we are
finalizing our proposed work RVU of 12.00 for CPT code 63030.
Comment: Commenters disagreed with our proposed work RVU of 3.86
for CPT code 63035, stating that it was a Harvard valued code with time
and work values that were generated from the base code, CPT code 63030.
Commenters expressed that the Harvard survey did not include all the
surgical specialties that now perform the service, with only 17
responses from neurosurgeons. Therefore, the commenters stated that the
previous intraservice time should not be used to arrive at a calculated
value. The commenters also expressed concern that CMS did not address
the compelling evidence provided by the RUC, and urged CMS to address
this rationale.
Response: We believe that it is important to use the recent data
available regarding work times, and we note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also believe that our operating assumption regarding
the validity of the existing values as a point of comparison is
critical to the integrity of the relative value system as currently
constructed. The work times currently associated with codes play a very
important role in PFS ratesetting, both as points of comparison in
establishing work RVUs and in the allocation of indirect PE RVUs by
specialty. If we were to operate under the assumption that previously
recommended work times had been routinely overestimated, this would
undermine the relativity of the work RVUs on the PFS in general, in
light of the fact that codes are often valued based on comparisons to
other codes with similar work times. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, which is why we apply various methodologies
to identify several potential work values for individual codes.
However, we reiterate that we believe it would be irresponsible to
ignore changes in time based on the best data available, and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
We remind commenters that the concept of compelling evidence was
developed by the RUC as part of its work RVU review process for
individual codes. The RUC determines whether there is compelling
evidence to justify an increase in valuation. The RUC's compelling
evidence criteria include documented changes in physician work, an
anomalous relationship between the code and multiple key reference
services, evidence that technology has changed physician work, analysis
of other data on time and effort measures, and evidence that incorrect
assumptions were made in the previous valuation of the service. While
we appreciate the submission of this additional information for review,
we emphasize that the RUC developed the concept of compelling evidence
for its own review process; an evaluation of ``compelling evidence,''
at least as conceptualized by the RUC, is not part of our review
process, as our focus is the time and intensity of services, in
accordance with the statute. With that stated, we do consider changes
in technology, patient population, and other compelling evidence
criteria, as such evidence may affect the time and intensity of a
service under review. For example, new technology may cause a service
to become easier or more difficult to perform, with corresponding
effects on the time and intensity of the service. However, we are under
no obligation to adopt the same review process or compelling evidence
criteria as the RUC. We instead focus on evaluating and addressing the
time and intensity of services when valuing codes because section
1848(c)(1)(A) of the Act specifically defines the work component as the
resources that reflect time and intensity in furnishing the service.
Therefore, we are finalizing a work RVU of 3.86 for CPT code 63035 as
proposed.
Comment: Two commenters disagreed with our proposal to remove 125
minutes of equipment time for EQ168 (light, exam) for CPT codes 63020
and 63030, stating that they believe the exam light is needed to check
for possible seroma and to examine and take out stitches. The
commenters urged CMS not to remove the exam light expense from these
code values.
Response: We proposed to remove the 125 minutes of equipment time
for EQ168 (light, exam) for CPT codes 63020 and 63030 because the RUC
contested the typicality of its use to assess the wound and remove
staples. Because it is a standard piece of equipment in a neurosurgeon
and orthopedic exam room, and the RUC questioned its typicality, we
proposed 0 minutes for EQ168 for CPT codes 63020 and 63030. We note
that we found five other 090-day codes in the CPT code 630XX series,
CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda equina and/or
nerve root[s], [eg, spinal or lateral recess stenosis]), single
vertebral segment; cervical), 63046 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; thoracic), 63047 (Laminectomy,
facetectomy and foraminotomy (unilateral or bilateral with
decompression of spinal cord, cauda equina and/or nerve root[s], [eg,
spinal or lateral recess stenosis]), single vertebral segment; lumbar),
63050 (Laminoplasty, cervical, with decompression of the spinal cord, 2
or more vertebral segments), and 63051 (Laminoplasty, cervical, with
decompression of the spinal cord, 2 or more vertebral segments; with
reconstruction of the posterior bony elements (including the
application of bridging bone graft and non-segmental fixation devices
[eg, wire, suture, mini-plates], when performed)) that do not have time
allotted to EQ168, despite their inclusion of ``Monitor wounds and
remove sutures/staples'' in their post-service descriptions, therefore
we do not believe this is a typical equipment input. Since we have not
received new information that contradicts the findings in the RUC
Database to indicate that the use of this equipment is typical, we are
finalizing 0 minutes for EQ168 for CPT codes 63020 and 63030 as
proposed.
[[Page 69499]]
(16) Somatic Nerve Injections (CPT Codes 64415, 64416, 64417, 64445,
64446, 64447, 64448, 76942, 77002, and 77003)
In May 2021, the CPT Editorial Panel revised the descriptors and
billing instructions for CPT codes 64415 (Injection(s), anesthetic
agent(s) and/or steroid; brachial plexus, including imaging guidance,
when performed), 64416 (Injection(s), anesthetic agent(s) and/or
steroid; brachial plexus, continuous infusion by catheter (including
catheter placement), including imaging guidance, when performed), 64417
(Injection(s), anesthetic agent(s) and/or steroid; axillary nerve,
including imaging guidance, when performed), 64445 (Injection(s),
anesthetic agent(s) and/or steroid; sciatic nerve, including imaging
guidance, when performed), 64446 (Injection(s), anesthetic agent(s)
and/or steroid; sciatic nerve, continuous infusion by catheter
(including catheter placement), including imaging guidance, when
performed), 64447 (Injection(s), anesthetic agent(s); femoral nerve,
including imaging guidance, when performed), 64448 (Injection(s),
anesthetic agent(s) and/or steroid; femoral nerve, continuous infusion
by catheter (including catheter placement), including imaging guidance,
when performed), 77002 (Fluoroscopic guidance for needle placement),
77003 (Fluoroscopic guidance and localization of needle or catheter tip
for spine or paraspinous diagnostic or therapeutic injection procedures
(epidural or subarachnoid)) and 76942 (Ultrasonic guidance for needle
placement, imaging supervision and interpretation). These codes were
then surveyed by the RUC in October 2021.
We last finalized values for CPT codes 64415, 64416, 64417, 64445,
64446, 64447, and 64448 in the CY 2020 PFS final rule (84 FR 62744
through 62745). In May 2018, the CPT Editorial Panel approved the
revision of descriptors and guidelines for codes in the somatic nerve
injection family. At its October 2018 meeting, the RUC recommended work
RVU and PE inputs for a number of somatic nerve injection codes,
including CPT codes 64415, 64416, 64417, 64445, 64446, 64447, and
64448. (Note that in 2018, the codes did not include ``including
imaging guidance, when performed'' in their descriptors.) During the
October 2018 RUC presentation for this family of services, the
specialty societies stated that CPT codes 64415, 64416, 64417, 64446,
66447, and 64448 were reported with the imaging code CPT code 76942
more than 50 percent of the time. In reviewing this family of services
in the CY 2020 PFS final rule, our finalized work and PE values for the
codes did not consider the simultaneous performance of injection and
imaging (84 FR 62744). In May 2021, the CPT Editorial Panel revised the
codes to include ``with imaging, when performed'' in the descriptors.
When presenting its CY 2023 valuation recommendations, the RUC
pointed out that the current values and times for CPT codes 64415,
64416, 64417, 64445, 64446, 64447, and 64448 reflect only the work and
time of the injection. The revised codes, however, include both
injection and imaging. In order to make an equitable comparison between
the RUC recommendations and the current values, the RUC suggested we
compare the RUC recommendations to values that combined the current
work and estimated time of the injection codes and the imaging code
with which they are being bundled, CPT code 76942. We agreed with this
approach and thank the RUC for providing combined work RVUs and
estimated combined times, which we considered as part of the RUC's
recommendations.
As part of its recommendations, the RUC reaffirmed its prior
recommendations for a number of codes that were previously reviewed or
reaffirmed in the CY 2020 PFS final rule, including: CPT codes 64400
(Injection(s), anesthetic agent(s); trigeminal nerve, each branch
(i.e., ophthalmic, maxillary, mandibular)), 64408 (Injection(s),
anesthetic agent(s), and/or steroid; vagus nerve), 64420 (Injection(s),
anesthetic agent(s) and/or steroid; intercostal nerve, single level),
64421 (Injection(s), anesthetic agent(s) and/or steroid; intercostal
nerves, each additional level (List separately in addition to code for
primary procedure)), 64425 (Injection(s), anesthetic agent(s) and/or
steroid; ilioinguinal, iliohypogastric nerves), 64430 (Injection(s),
anesthetic agent(s) and/or steroid; pudendal nerve), 64435
(Injection(s), anesthetic agent(s) and/or steroid; paracervical
(uterine) nerve), 64449 (Injection(s), anesthetic agent(s) and/or
steroid; lumbar plexus, posterior approach, continuous infusion by
catheter (including catheter placement)), and 64450 (Injection(s),
anesthetic agent(s); other peripheral nerve or branch) (84 FR 62744
through 62745); CPT code 64451 (Injection(s), anesthetic agent(s) and/
or steroid; nerves innervating the sacroiliac joint, with image
guidance (ie, fluoroscopy or computed tomography) (84 FR 62740); and
CPT code 64454 (Injection(s), anesthetic agent(s) and/or steroid;
genicular nerve branches including imaging guidance, when performed)
(84 FR 62749). The RUC also reaffirmed its recommendation for CPT code
64455 (Injection(s), anesthetic agent(s) and/or steroid; plantar common
digital nerve(s) (e.g., Morton's neuroma)), which was reviewed and
valued in the CY 2019 PFS final rule (83 FR 58542). The codes the RUC
wishes to reaffirm for CY 2023 have not been revised by the CPT
Editorial Panel and were not resurveyed by the RUC since their prior
valuation. Since we did not receive new information regarding these
codes, we acknowledged the RUC's reaffirmation but we did not review
the values of these codes in the proposed rule. In the proposed rule,
we also noted that the RUC-reaffirmed values for CPT codes 64435 (work
RVU of 0.75), 64450 (work RVU of 0.75), 64451 (work RVU of 1.52), and
64454 (work RVU of 1.52) are the same as the current work RVUs that we
finalized in the CY 2020 PFS final rule. The RUC reaffirmed work RVU of
0.94 for CPT code 64405 is the current work RVU, which was finalized in
the CY 2019 PFS final rule (83 FR 59542) and reaffirmed in the CY 2020
final rule, and the RUC-reaffirmed work RVU of 1.10 for CPT code 64418
is the current work RVU value finalized in the CY 2018 PFS final rule
(82 FR 53054) and reaffirmed in the CY 2020 PFS final rule. The RUC
reaffirmed a work RVU of 0.75 for CPT code 64455 which is the current
work RVU we finalized in the CY 2019 PFS final rule (83 FR 58542).
For CY 2023, we proposed the RUC-recommended work RVUs for CPT
codes 64417 (work RVU of 1.31), 64447 (work RVU of 1.34), 64448 (work
RVU of 1.68), 77002 (work RVU of 0.54), 77003 (work RVU of 0.60), and
76942 (work RVU of 0.67).
For CPT code 64415, we disagreed with the RUC-recommended work RVU
of 1.50 and proposed a work RVU of 1.35, based on the intraservice time
ratio calculated using the ``combined'' values for CPT code 64415 and
the imaging CPT code 76942 provided by the RUC. (The combined work RVU
the RUC offered for comparison was 2.02 (the sum of the work RVUs for
both codes: CPT code 64415 is 1.35 and CPT code 76942 is 0.67), and an
estimated intraservice time of 15 minutes and total time of 43
minutes.) This proposed work RVU of 1.35 for CPT code 64415 is
supported by a crosswalk to CPT code 11982 (Removal, non-biodegradable
drug delivery implant), which has a work RVU of 1.34, an identical
service time, and a total time that is two minutes lower than CPT code
64415. This value is further supported by a bracket of CPT codes: CPT
code 64486
[[Page 69500]]
and CPT code 33285. CPT code 64486 (Transversus abdominis plane (TAP)
block (abdominal plane block, rectus sheath block) unilateral; by
injection(s) (includes imaging guidance, when performed)) has a work
RVU of 1.27 and identical intraservice and total time values to CPT
code 64415, and CPT code 33285 (insertion, subcutaneous cardiac rhythm
monitor, including programming) has a work RVU of 1.53, an intraservice
time of 10 minutes and a total time of 40 minutes.
We noted that when compared to the current time file information
for CPT code 64415, the RUC-recommended intraservice time decreased
from 12 to 10 minutes (16.7 percent reduction) and RUC-recommended
total time decreased from 40 to 35 minutes (12.5 percent reduction).
However, the RUC-recommended work RVU increased by 0.15 which is an
11.1 percent increase. Although we do not imply that the decrease in
time as reflected in survey values must always equate to a one-to-one
or linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should not be
met with significant increases to work RVUs without adequate
justification. Additionally, while we do acknowledge that adding
imaging does bundle some additional work into the code, we do not
believe that the recoding of the services in this family has resulted
in a significant increase in their intensity, only a change in the way
in which they will be reported, and through the bundling of some of
these frequently reported services, it is reasonable to expect that the
new coding system will achieve efficiencies via elimination of
duplicative assumptions of the resources involved in furnishing
particular services. We believe the new coding assigns more accurate
work times, and thus, reflects efficiencies in resource costs that
existed but were not reflected in the services as they were previously
reported. If the addition of imaging guidance had made the new CPT
codes significantly more intense to perform, we believe that this would
have been reflected in the surveyed work times, which in the case of
CPT code 64415 actually decreased from the predecessor code. Thus, we
are disinclined to ignore the impact of decreased times on the work
RVU. We believe our proposed value of 1.35 appropriately reflects both
the additional work and the decrease of time.
We considered proposing a work RVU of 1.27 for CPT code 64415,
using CPT code 64486 as a comparison code, since it has the same
intraservice and total times as the revised CPT code 64415. However,
CPT code 64486, with a work RVU of 1.27, has a lower work RVU than the
current work RVU of 64415 (1.35.) We are in general agreement with the
RUC that it is important to acknowledge that there is some additional
work that comes with adding imaging to this procedure.
For CPT code 64416, we disagreed with the RUC-recommended work RVU
of 1.80 and instead proposed a work RVU of 1.65. While we disagreed
with the RUC's recommended work RVU, we did agree with the RUC's
proposed increment of +0.30 between CPT codes 64415 and 64416. (The RUC
recommendation for CPT code 64415 was 1.50, and the recommendation for
CPT code 64416 was 1.80.) We found persuasive the RUC's observation
that the current increment between CPT codes 64415 and 64416 is
unusually small when compared to other sets of related codes in the
family. Typically, the codes that add catheter placement in addition to
the injection are 0.30-0.36 work RVUs higher than the codes for an
injection in the same nerve group or region. Retaining such a narrow
interval of 0.15 between CPT codes 64415 and 64416 would create a rank
order anomaly within the family in light of adjustments to some of the
other codes' work RVUs. Our proposed work RVU of 1.65 for CPT code
64416 is supported by a bracket of CPT codes: CPT code 64448 and CPT
code 36573. CPT code 64448 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) bilateral; by injections
(includes imaging guidance, when performed)) has a work RVU of 1.60, 15
minutes intraservice time and 40 minutes total time, and CPT code 36573
(Insertion of peripherally inserted central venous catheter (PICC),
without subcutaneous port or pump, including all imaging guidance,
image documentation, and all associated radiological supervision and
interpretation required to perform the insertion; age 5 years or older)
has a work RVU of 1.70, 15 minutes intraservice time and 40 minutes
total time.
We noted that, when compared to the current time file, the RUC-
recommended intraservice time for CPT code 64416 decreased from 20 to
15 minutes (25 percent reduction) and the RUC-recommended total time
decreased from 49 to 44 minutes (10.2 percent reduction). However, the
RUC recommended a 0.32 increase in the work RVU, which is a 21.6
percent increase. We noted that the RUC-recommended work RVU of 1.80
would give CPT code 64416 the highest work RVU of the surveyed codes,
and would make it among the highest valued codes in the family. We do
not believe the RUC-recommended work RVU appropriately accounts for the
reductions in the surveyed total time for the procedure, and did not
receive specific information explaining why, despite the decrease in
time, the value should receive such a significant increase relative to
the other surveyed codes. As stated previously, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased significantly, decreases in time should be
reflected in the revised work RVUs. As noted in our discussion of CPT
code 64415 above, if the addition of imaging guidance had made the new
CPT codes significantly more intense to perform, we believe that this
would have been reflected in the surveyed work times, which in the case
of CPT code 64416, are now actually lower. We believe our proposed work
RVU of 1.65 corrects the increment between CPT code 64415 and 64416,
while also acknowledging that, the addition of imaging notwithstanding,
the times for CPT code 64416 have noticeably decreased.
For CPT code 64445, we disagreed with the RUC-recommended work RVU
of 1.39 and instead proposed a work RVU of 1.28, based on the
intraservice time ratio calculated using the ``combined'' values for
CPT code 64445 and the imaging CPT code 76942 provided by the RUC. (The
combined work RVU the RUC offered for comparison was 1.67 (the sum of
the work RVUs for both codes: CPT code 64445 is 1.00 and CPT code 76942
is 0.67), and an estimated intraservice time of 13 minutes and total
time of 27 minutes.) This proposed value of 1.28 is supported by a
comparison to CPT code 64486 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) unilateral; by
injection(s) (includes imaging guidance, when performed)), which has a
work RVU of 1.27 and intraservice time of 10 minutes and total time of
35 minutes. The value is also supported by a low bracket of CPT code
58100 (Endometrial sampling (biopsy) with or without endocervical
sampling (biopsy), without cervical dilation, any method (separate
procedure)), with a work RVU of 1.21, identical intraservice time and
almost identical total time, and a high bracket
[[Page 69501]]
of CPT code 11982 (Removal, non-biodegradable drug delivery implant),
with a work RVU of 1.34, identical intraservice time and a higher total
time of 33 minutes.
We noted that the RUC-recommended intraservice time and total time
for CPT code 64445 are identical to the current intraservice and total
times in the time file for CPT code 64445. However, the RUC recommended
a 0.39 increase to the work RVU. We do not imply that the lack of
change to the intraservice and total times means that the work RVU
cannot be increased. We believe that since the two components of work
are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, the RUC-proposed increase in the work RVU does not seem
justified. As noted in our discussion of CPT code 64415 above, if the
addition of imaging guidance had made the new CPT codes significantly
more intense to perform, we believe that this would have been reflected
in the surveyed work times, which in the case of CPT code 64445, are
the same as the predecessor code.
We considered proposing a work RVU of 1.10 for CPT code 64445,
using CPT code 30901 (Control nasal hemorrhage, anterior, simple
(limited cautery and/or packing) any method) as a comparison code, with
a work RVU of 1.10 and identical intraservice and total times as CPT
code 64445. However, we believed this would cause a rank order anomaly
within the family. For example, CPT code 64418 (Injection(s),
anesthetic agent(s) and/or steroid; suprascapular nerve) also has a
work RVU of 1.10, but does not include imaging. Again, we generally
agree with the RUC that it is important to acknowledge the additional
work that comes with adding imaging to this procedure, and to ensure
that this additional work is reflected within the relative values of
the family, but we still proposed a work RVU of 1.28 for CPT code
64445.
For CPT code 64446, we disagreed with the RUC-recommended work RVU
of 1.75 and instead proposed a work RVU of 1.64. This recommended work
RVU is 0.36 higher than the proposed work RVU for CPT code 64445
(1.28). We noted that the current increment between the current values
of 64445 and 64446 (1.00 and 1.36, respectively) is 0.36. The RUC
recommendations for these codes (1.39 and 1.75) preserved this
increment. Since the same imaging activity is being added to both
codes, we agree with preserving the relationship between the values of
CPT codes 64445 and 64446. Our proposed work RVU of 1.64 for CPT code
64446 is supported by a bracket of CPT codes: CPT code 64448 and 36573.
CPT code 64448 (Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) bilateral; by injections (includes
imaging guidance, when performed)) has a work RVU of 1.60, 15 minutes
intraservice time and 40 minutes total time, and CPT code 36573
(Insertion of peripherally inserted central venous catheter (PICC),
without subcutaneous port or pump, including all imaging guidance,
image documentation, and all associated radiological supervision and
interpretation required to perform the insertion; age 5 years or older)
has a work RVU of 1.70, 15 minutes intraservice time and 40 minutes
total time. (We noted that this is the same bracket we suggested to
support the proposed value for CPT code 64416. As revised, the
intraservice and total times for CPT codes 64416 and 64446 are the
same.)
We noted that, compared to the time file for CPT code 64446, the
RUC-recommended intraservice time stayed the same (15 minutes) and the
total time increased from 40 to 44 minutes (10 percent increase). The
RUC-recommended work RVU for CPT code 64446, is 0.39 higher than the
current RVU, a 28.7 percent increase. We believe the RUC-recommended
work RVU increase is disproportionate to the change in time.
Additionally, we noted that the RUC-recommended times result in CPT
code 64416 and CPT code 64446 having identical intraservice and total
times. We believe it best preserves rank order within the family to
assign CPT code 64416 and CPT code 64446 similar work RVUs.
We proposed the direct PE inputs as recommended by the RUC for all
of the codes in the Somatic Nerve Injections family.
We would like to correct a typographical error. We note that in
several places in the CY 2023 proposed rule at 87 FR 45919, the number
``64488'' in CPT code 64488 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) bilateral; by injections
(includes imaging guidance, when performed) was misidentified as
``64448.''
Comment: A number of commenters expressed support of our proposed
work RVUs for CPT codes 64417, 64447, 64448, 77002 77003, and 76942.
Response: We thank the commenters for their support.
Comment: Several commenters expressed concerns about all of our
proposed values (including those that aligned with the RUC-recommended
valuations), which they did not believe reflected the combined work of
both the injection and the imaging. Commenters indicated that the
addition of imaging makes the injection procedure more efficient and
improves success rates for patients. They also noted that somatic nerve
injections are important treatments for pain management and can be an
alternative to opioid prescription.
Response: We agree with commenters that somatic nerve injections
are a valuable pain management service. However, under allowing the
codes (which were frequently being performed simultaneously) meant that
there was duplication in payments for components of the practitioner's
time, effort, and PE when performing; what was essentially a combined
procedure was being billed as though it was two standalone procedures.
We agreed with, and appreciated the CPT and RUC's decision to revise
and revalue the codes to reflect a bundling of the somatic nerve
injection and imaging procedures.
Comment: Commenters disagreed with our proposed work RVUs for CPT
codes 64415, 64416, 64445 and 64446 and urged us to accept the RUC
recommendations. Commenters disagreed with some of the codes we
selected to use as brackets or crosswalks to support our proposed
valuations on the basis that the codes we selected did not include
imaging.
Response: We disagree that some of the codes used as brackets or
crosswalks were inappropriate simply because they did not include
imaging. We continue to believe that the nature of the PFS relative
value system is such that all services are appropriately subject to
comparisons to one another. Although codes that describe clinically
similar services are sometimes stronger comparator codes, we do not
agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate code
comparison or an appropriate crosswalk.
Comment: Some commenters disagree with our use of time ratios to
calculate proposed RVUs for CPT codes 64415 and 64445, stating that
they believed the intraservice time ratio did not consider the combined
work of both the injections and the imaging described by the revised
code descriptors.
Response: We disagree that our use of time ratio calculations was
inappropriate. As stated in the proposed rule, we specifically used the
RUC's projected ``combined'' RVU and intraservice time for CPT codes
64415 and 64445 when performing our intraservice time ratio
calculations. It
[[Page 69502]]
was our understanding that the RUC provided this information to
demonstrate values reflecting the combined work of the revised codes.
Comment: Some commenters disagree with our use of increments to
support our proposed values for CPT codes 64416 and 64446.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes.
Comment: Commenters reiterated that CPT codes 64415, 64416, 64445,
and 64446 (revised to add imaging) now describe work that is more
intense than the previous codes (which described injections without the
imaging). Commenters stated that the RUC recommendations better
reflected the intensity of this new work.
Additionally, several commenters provided detailed clinical
information explaining that injections to the sciatic nerve (which are
described in CPT codes 64445 and 64446) are more intense than
injections to the femoral artery (CPT codes 64447 and 64448.) Several
commenters also provided clinical information demonstrating that
injections to the brachial plexus (which are described by CPT codes
64415 and 64416) are more intense than injections to the sciatic nerve
(which are described by CPT codes 64445 and 64446.)
Response: As explained in the proposed rule, we believed that our
proposed RVUs for CPT codes 64415, 64416, 64445, and 64446 acknowledged
the increased work of the codes while also reflecting their respective
changes in time. However, we consider clinical information associated
with physician work intensity provided by the RUC and other interested
parties as part of our review process, and we found the additional
clinical information helpful by providing greater insight into relative
intensity within this code family. We note that to determine work RVUs,
we must look at both time and intensity. We must also consider
relativity: if two codes have the same work time, but one code has a
higher intensity, relativity dictates that the higher-intensity code
gets more RVUs.
For CPT code 64445 (injection of sciatic nerve, with imaging, if
performed), we proposed a work RVU of 1.28; the code had a surveyed
intraservice time of 10 minutes. For CPT code 64447 (injection of
femoral artery, with imaging, if performed), we had proposed a work RVU
of 1.34; the code has an intraservice time of 8 minutes. In light of
the additional information that injections to the sciatic nerve are
more intense than injections to the femoral nerve (coupled with the
fact that CPT code 64445 has a longer intraservice time than CPT code
64447), we now agree that the RUC recommendation of 1.39 for CPT code
64445 better supports relativity.
For CPT code 64446 (injection of sciatic nerve with catheter
placement, with imaging, if performed), we had proposed a work RVU of
1.64; the code has 15 minutes of intraservice time. We proposed a work
RVU of 1.68 for CPT code 64448 (injection of femoral nerve with
catheter placement, with imaging, if performed); the code has an
intraservice time of 15 minutes. In light of the additional information
that sciatic nerve injections are more intense than femoral injections
(coupled with the fact that CPT codes 64446 and 64448 have the same
intraservice time), we now agree that the RUC recommendation of 1.75
for CPT code 64446 better supports relativity.
For CPT code 64415 (injection to the brachial plexus, with imaging,
if performed), we proposed a work RVU of 1.35; the code has an
intraservice time of 10 minutes. As noted above, we now agree with a
work RVU of 1.39 for CPT code 64445 (injection of sciatic nerve, with
imaging, if performed); the code also has 10 minutes of intraservice
time. In light of the additional information that brachial nerve
injections are more intense than sciatic nerve injections (coupled with
the fact that CPT codes 64415 and 64445 have the same intraservice
time), we now agree that the RUC recommendation of 1.50 for CPT code
64415 better supports relativity.
For CPT code 64416 (injection to the brachial plexus with catheter
placement, with imaging, if performed), we proposed a work RVU of 1.65;
the code has an intraservice time of 15 minutes. As noted above, we now
agree with a work RVU of 1.75 for CPT code 64446 (injection of sciatic
nerve with catheter placement, with imaging, if performed); the also
code has 15 minutes of intraservice time. In light of the additional
information that brachial nerve injections are more intense than
sciatic nerve injections (coupled with the fact that CPT codes 64416
and 64446 have the same intraservice time), we now agree that the RUC
recommendation of 1.80 for CPT code 64416 better supports relativity.
Based on the comments, we are finalizing the work RVUs for CPT
codes 64417, 64447, 64448, 77002, 77003, and 76942. and the PE inputs
for all codes, as proposed. We are finalizing the RUC recommended work
RVU of 1.50 for CPT code 64415; 1.80 for CPT code 64416; 1.39 for CPT
code 64445; and 1.75 for CPT code 64446.
(17) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714,
69716, 69717, 69719, 69726, 69727, 69729, 69730, and 69728)
In October 2020, the CPT Editorial Panel deleted two codes used for
mastoidectomy and replaced them with four new codes for magnetic
transcutaneous attachment to external speech processor. The CPT
Editorial Panel made additional revisions to differentiate
implantation, removal, and replacement of the implants. The RUC
submitted interim recommendations to CMS for six codes in this family
following the January 2021 RUC meeting, and we proposed and finalized
the recommended work RVU for all six of these codes in the CY 2022 PFS
final rule (86 FR 65099 through 65100). For CY 2023, the CPT Editorial
Panel established three additional new codes and the coding structure
of the family was changed to describe the different techniques more
appropriately for transcutaneous passive implant procedures that vary
in time and intensity depending on the indication for the procedure,
device chosen, and patient anatomy. The nine codes in the family were
surveyed again for the January 2022 RUC meeting and new recommendations
were submitted to CMS.
We proposed the RUC-recommended work RVU for six of the nine codes
in the Transcutaneous Passive Implant-Temporal Bone family. We proposed
a work RVU of 9.03 for CPT code 69716 (Implantation, osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor within the mastoid and/or resulting in removal of less
than 100 mm2 surface area of bone deep to the outer cranial cortex), a
work RVU of 9.97 for CPT code 69729 (Implantation, osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor, outside of the mastoid and resulting in removal of
greater than or equal to 100 mm2 surface area of bone deep to the outer
cranial cortex), a work RVU of 9.46 for CPT code 69719 (Revision/
replacement (including removal of existing device), osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor, within the mastoid and/or involving a bony defect
less than 100 mm2 surface area of bone
[[Page 69503]]
deep to the outer cranial cortex), a work RVU of 10.25 for CPT code
69730 (Revision/replacement (including removal of existing device),
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor, outside the mastoid and involving a bony
defect greater than or equal to 100 mm2 surface area of bone deep to
the outer cranial cortex), a work RVU of 7.38 for CPT code 69727
(Removal, entire osseointegrated implant, skull; with magnetic
transcutaneous attachment to external speech processor, within the
mastoid and/or involving a bony defect less than 100 mm2 surface area
of bone deep to the outer cranial cortex), and a work RVU of 8.50 for
CPT code 69728 (Removal, entire osseointegrated implant, skull; with
magnetic transcutaneous attachment to external speech processor,
outside the mastoid and involving a bony defect greater than or equal
to 100 mm2 surface area of bone deep to the outer cranial cortex).
We disagreed with the RUC's recommended work RVU for the other
three codes in the family for the procedures describing percutaneous
attachment to external speech processor. We disagreed with the RUC's
recommended work RVU of 8.00 for CPT code 69714 (Implantation,
osseointegrated implant, skull; with percutaneous attachment to
external speech processor) and we instead proposed a work RVU of 6.68
based on a crosswalk to CPT code 38305 (Drainage of lymph node abscess
or lymphadenitis; extensive). In reviewing CPT code 69714, we noted
that the recommended intraservice time is decreasing from 40 minutes to
30 minutes (25 percent reduction), and the recommended total time is
decreasing from 182 minutes to 146 minutes (20 percent reduction);
however, the RUC-recommended work RVU is only decreasing from 8.69 to
8.00, which is a reduction of just over 8 percent. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 69714, we
believed that it was more accurate to propose a work RVU of 6.68 based
on a crosswalk to CPT code 38305 to account for these decreases in the
surveyed work time.
We also disagreed with the recommended work RVU of 8.00 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family. At the recommended work RVU of 8.00, the
intensity of CPT code 69714 is increasing by nearly 50 percent as
compared with the survey conducted last year, and the resulting
intensity of the service would be significantly higher than any of the
other codes in the family. We did not agree that this intensity would
be typical given that the percutaneous form of implant described by CPT
code 69714 should have the lowest intensity of the three types
described in this code family. The implantation procedure described by
this code should also typically have lower intensity than the revision/
replacement procedures elsewhere in the family. We believed that the
intensity of CPT code 69714 is more accurately described at our
proposed work RVU of 6.68 based on a crosswalk to CPT code 38305. This
code shares the same intraservice time of 30 minutes as CPT code 69714
and has a higher total time of 186 minutes; we agreed that CPT code
69714 is more intense than CPT code 38305 which was offset by our
crosswalk code having an additional office visit in its global period.
We disagreed with the RUC's recommended work RVU of 8.48 for CPT
code 69717 (Revision/replacement (including removal of existing
device), osseointegrated implant, skull; with percutaneous attachment
to external speech processor) and we instead proposed a work RVU of
7.91 based on a crosswalk to CPT code 46262 (Hemorrhoidectomy, internal
and external, 2 or more columns/groups; with fistulectomy, including
fissurectomy, when performed). In reviewing CPT code 69717, we noted
that although the intraservice time remains essentially unchanged
(decreasing from 45 minutes to 44 minutes), the recommended total time
is decreasing from 187 minutes to 159 minutes (15 percent reduction).
However, the RUC-recommended work RVU was only decreasing from 8.80 to
8.48, which is a reduction of less than 4 percent. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 69717, we
believed that it was more accurate to propose a work RVU of 7.91 based
on a crosswalk to CPT code 46262 to account for these decreases in the
surveyed work time.
We also disagreed with the recommended work RVU of 8.48 because it
resulted in a higher intensity than the other two revision/replacement
codes (CPT codes 69719 and 69730) in this family. CPT code 69717
describes the percutaneous form of implant which should have the lowest
intensity of the three revision/replacement codes in this family,
however at the recommended work RVU of 8.48 it would have the highest
intensity of this group. While the intensity at the recommended work
RVU for CPT code 69717 is nowhere near the anomalous nature of the
intensity at the recommended work RVU for CPT code 69714, we still
believed that the intensity would be more typical at the proposed work
RVU of 7.91. This proposed valuation restores the relationship between
the three revision/replacement codes by placing the intensity of CPT
code 69717 slightly lower than CPT codes 69719 and 69730. Therefore, we
believed that the intensity of CPT code 69717 was more accurately
described at our proposed work RVU of 7.91 based on a crosswalk to CPT
code 46262. This code has nearly the same intraservice time of 45
minutes as CPT code 69717 and has a higher total time of 179 minutes;
we agreed that CPT code 69717 is more intense than CPT code 46262 which
was offset by our crosswalk code having an additional office visit in
its global period.
We disagreed with the RUC's recommended work RVU of 7.50 for CPT
code 69726 (Removal, entire osseointegrated implant, skull; with
percutaneous attachment to external speech processor) and we instead
proposed a work RVU of 6.36 based on a crosswalk to CPT code 67912
(Correction of lagophthalmos, with implantation of upper eyelid lid
load (e.g., gold weight)). In reviewing CPT code 69726, we noted that
the recommended intraservice time was increasing from 30 minutes to 35
minutes (17 percent increase), and the recommended total time was
increasing from 148 minutes to 150 minutes (1 percent increase);
however, the RUC-recommended work RVU was increasing from 5.93 to 7.50,
which was an increase of just over 26 percent. Although we did not
imply that the increase in time as reflected in survey values must
equate to a one-to-one or linear increase in the valuation of work
RVUs, we believed that since the two components of work are time and
intensity, modest increases in time should be appropriately reflected
in modest increases to work RVUs. In the case of CPT code 69726, we
believed that it was more accurate to propose a work RVU of 6.36 based
on a crosswalk
[[Page 69504]]
to CPT code 67912 to account for these increases in the surveyed work
time.
We also disagree with the recommended work RVU of 7.50 because it
resulted in an intensity which is anomalously high in relationship to
the rest of the code family and created a rank order anomaly within the
work RVUs. CPT code 69726 describes the percutaneous form of the
removal procedure which should have the lowest intensity of all nine
codes in this family. However, the intensity of CPT code 69726 at the
recommended work RVU of 7.50 would be the second-highest in the family,
even higher than CPT code 69730 which describes the revision/
replacement procedure with magnetic transcutaneous attachment resulting
in removal of greater than or equal to 100 square mm surface area of
bone. We did not agree that this would be typical and we believed that
the intensity would be more accurate at our proposed work RVU of 6.36.
We also noted that the recommended work RVU of 7.50 for CPT code 69726
creates a rank order anomaly within the family as it would be higher
than the recommended work RVU of 7.38 for CPT code 69727 which
describes a more complex procedure and has higher surveyed work times.
Therefore, we believed that the work and intensity of CPT code 69726
were more accurately described at our proposed work RVU of 6.36 based
on a crosswalk to CPT code 67912. This code has nearly the same
intraservice time of 40 minutes as CPT code 69726 and has a higher
total time of 166 minutes; we agreed that CPT code 69726 is more
intense than CPT code 69726 which was offset by our crosswalk code
having an additional office visit in its global period.
We proposed the direct PE inputs as recommended by the RUC for all
nine codes in the Transcutaneous Passive Implant-Temporal Bone family.
Comment: Several commenters disagreed with CMS' use of the current
work RVUs and work times when reviewing the codes in the Transcutaneous
Passive Implant-Temporal Bone family. Commenters stated that CMS was
comparing work RVUs and work times to an interim recommendation that
was made interim due to a flawed survey process. Commenters stated that
the RUC reviewed this family of services and determined that they
needed to be resurveyed with a revised Reference Service List (RSL) to
encompass a larger range of relative values, specifically to include
the lower end of the RVU spectrum. Commenters stated that CMS should
not use the interim recommendations as a base to arrive at new work
RVUs for the codes in this family.
Response: We disagree with the commenters that it was inappropriate
to use the current work RVUs and work times that were active for CY
2022 when evaluating the codes in the Transcutaneous Passive Implant-
Temporal Bone family. As we stated earlier in the Methodology for
Establishing Work RVUs portion of this section, we believe that our
operating assumption regarding the validity of the existing values as a
point of comparison is critical to the integrity of the relative value
system as currently constructed. The work times currently associated
with codes play a very important role in PFS ratesetting, both as
points of comparison in establishing work RVUs and in the allocation of
indirect PE RVUs by specialty. If we were to operate under the
assumption that previously recommended work times had been routinely
overestimated, this would undermine the relativity of the work RVUs on
the PFS in general, in light of the fact that codes are often valued
based on comparisons to other codes with similar work times. Instead,
we believe that it is crucial that the code valuation process take
place with the understanding that the existing work times that have
been used in PFS ratesetting are accurate. Even if the work RVUs and
work RVUs for the codes in the Transcutaneous Passive Implant-Temporal
Bone family were recommended to CMS on an interim basis, they were used
for payment throughout CY 2022 and are appropriately subject to
comparisons when evaluating the updated recommendations for CY 2023. We
also note that we proposed and finalized those interim work RVUs and
work times as recommended by the RUC without refinement.
Furthermore, the use of older work RVUs and older work times that
predate the interim recommendations from CY 2022 would not have changed
the analysis that we performed indicating that several of the codes in
the Transcutaneous Passive Implant-Temporal Bone family were overvalued
as recommended by the RUC. For example, CPT code 69714 previously had a
work RVU of 14.45 and an intraservice work time of 90 minutes before
its CY 2022 interim review. If we were to use these values as the basis
for our review, the recommended intraservice time would decrease from
90 minutes to 30 minutes (67 percent reduction) however, the RUC-
recommended work RVU would only decrease from 14.45 to 8.00, which is a
reduction of just under 45 percent. Regardless of whether the starting
point of comparison is the interim CY 2022 values or the historic CY
2007 values, we continue to believe that several of the codes in this
family are more accurately described using our proposed work RVUs.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 6.68 for CPT code 69714 and stated that CMS should instead
finalize the RUC-recommended work RVU of 8.00. Commenters disagreed
that the recommended intensity for CPT code 69714 was too high and
stated that the code describes an intense and complex surgery on a
highly sensitive sensory organ, operating in a small space where
millimeters of difference lead to cerebrospinal fluid leak and
intracranial vascular injury. Commenters disagreed with the CMS
crosswalk to CPT code 38305 and stated that CPT code 69714 requires
more physician work as it is a more intense service than CPT code
38305, which instead describes the less intense work of draining a
lymph node abscess. Commenters also stated that CPT code 38305 was last
reviewed 22 years ago and is not widely performed, and therefore,
should not be used as a crosswalk code.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 6.68 is a more accurate choice for CPT
code 69714. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69714
found that the typical intraservice time required to perform the
procedure had significantly decreased (from both the historic and
interim work time values) and we believe that this decrease in work
time should be reflected in a corresponding decrease in the work RVU.
Even if the decrease in work time was due to greater efficiencies in
delivering the service, this decrease in work time should be reflected
in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 38305 is an appropriate choice as a crosswalk for CPT code
69714. CPT code 38305 describes the extensive drainage of a lymph node
abscess or lymphadenitis procedure; we stated in the proposed rule that
we agreed that CPT code 69714 is more intense than CPT code 38305 which
is offset by our crosswalk code having an additional office visit in
its global period. We also emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are
[[Page 69505]]
appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
We also disagreed with the recommended work RVU of 8.00 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family. At the recommended work RVU of 8.00, the
intensity of CPT code 69714 is increasing by nearly 50 percent as
compared with the survey conducted last year (and by more than 60
percent as compared with the historic pre-interim survey intensity),
and the resulting intensity of the service would be significantly
higher than any of the other codes in the family. We do not agree that
this intensity would be typical given that the percutaneous form of
implant described by CPT code 69714 should have the lowest intensity of
the three types described in this code family. The implantation
procedure described by this code should also typically have lower
intensity than the revision/replacement procedures elsewhere in the
family. Aside from stating that CPT code 69714 describes an intense
surgery and pointing out that it had a higher intensity than CPT code
69717 at the proposed work RVU, commenters did not respond to our
analysis that the recommended work RVU of 8.00 resulted an anomalously
high intensity. As such, we continue to believe that the proposed work
RVU of 6.68 for CPT code 69714 is a more accurate choice than the RUC-
recommended work RVU of 8.00.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 7.91 for CPT code 69717 and stated that CMS should instead
finalize the RUC-recommended work RVU of 8.48. Commenters stated that
for the procedures described by CPT code 69717, the practitioner must
work with a variety of delicate structures in a very small space just
behind the ear which makes these procedures very intense and complex to
perform. Commenters stated that the work per unit time as recommended
by the RUC for CPT code 69717 was already lower than CPT codes 69719
and 69730. Commenters disagreed with the CMS crosswalk to CPT code
46262 and stated that CPT code 69717 requires more physician work than
CPT code 46262. Commenters also stated that CPT code 46262 was last
reviewed 22 years ago and is not widely performed, and therefore,
should not be used as a crosswalk code.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 7.91 is a more accurate choice for CPT
code 69717. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69717
found that the typical intraservice time required to perform the
procedure had significantly decreased (from both the historic and
interim work time values) and we believe that this decrease in work
time should be reflected in a corresponding decrease in the work RVU.
Even if the decrease in work time was due to greater efficiencies in
delivering the service, this decrease in work time should be reflected
in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 46262 is an appropriate choice as a crosswalk for CPT code
69717. CPT code 46262 describes a hemorrhoidectomy with fistulectomy
which requires a similar level of risk and complexity to the patient;
we stated in the proposed rule that we agreed that CPT code 69717 is
more intense than CPT code 46262 which is offset by our crosswalk code
having an additional office visit in its global period. We also
emphasize that we continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes that describe
clinically similar services are sometimes stronger comparator codes, we
do not agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate crosswalk.
We also disagreed with the recommended work RVU of 8.48 because it
results in a higher intensity than the other two revision/replacement
codes (CPT codes 69719 and 69730) in this family. CPT code 69717
describes the percutaneous form of implant which should have the lowest
intensity of the three revision/replacement codes in this family,
however at the recommended work RVU of 8.48 it would have the highest
intensity of this group. While the intensity at the recommended work
RVU for CPT code 69717 is nowhere near the anomalous nature of the
intensity at the recommended work RVU for CPT code 69714, we still
believe that the intensity would be more typical at the proposed work
RVU of 7.91. Commenters stated that the work per unit time as
recommended by the RUC for CPT code 69717 was already lower than CPT
codes 69719 and 69730 but otherwise did not respond to our discussion
of the intensity of the code and how it related to the other revision/
replacement codes in this family. As such, we continue to believe that
the proposed work RVU of 7.91 for CPT code 69717 is a more accurate
choice than the RUC-recommended work RVU of 8.48.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 6.36 for CPT code 69726 and stated that CMS should instead
finalize the RUC-recommended work RVU of 7.50. Commenters stated that
for CPT code 69726, the practitioner must work with a variety of
delicate structures in a very small space just behind the ear which
makes these procedures very intense and complex to perform. Commenters
disagreed with the CMS crosswalk to CPT code 67912 and stated that CMS
should not apply this crosswalk because CPT code 67912 is an
infrequently performed service that has not been reviewed by the RUC or
CMS in 20 years, has disparate times from the survey code, and
typically involves less physician work.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 6.36 is a more accurate choice for CPT
code 69726. As we stated in the proposed rule, since the two components
of work are time and intensity, decreases in time should typically be
reflected in decreases to work RVUs. The survey for CPT code 69726
found that the typical intraservice time required to perform the
procedure had significantly decreased and we believe that this decrease
in work time should be reflected in a corresponding decrease in the
work RVU. Even if the decrease in work time was due to greater
efficiencies in delivering the service, this decrease in work time
should be reflected in the work RVU for the service in question.
We also disagree with the commenters and continue to believe that
CPT code 67912 is an appropriate choice as a crosswalk for CPT code
69726. CPT code 67912 describes a correction of lagophthalmos, with
implantation of upper eyelid lid load; we acknowledged in the proposed
rule that the work times were not an exact match with CPT code 69726
but closely matched the intraservice and total times. We also stated in
the proposed rule that we agreed that CPT code 69726 is more intense
than CPT code 69726 which is offset by our crosswalk code having an
additional office visit in its global period. We also emphasize that we
[[Page 69506]]
continue to believe that the nature of the PFS relative value system is
such that all services are appropriately subject to comparisons to one
another. Although codes that describe clinically similar services are
sometimes stronger comparator codes, we do not agree that codes must
share the same site of service, patient population, or utilization
level to serve as an appropriate crosswalk.
We also disagreed with the recommended work RVU of 7.50 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family and creates a rank order anomaly within the
work RVUs. CPT code 69726 describes the percutaneous form of the
removal procedure which should have the lowest intensity of all nine
codes in this family. However, the intensity of CPT code 69726 at the
recommended work RVU of 7.50 would be the second-highest in the family,
even higher than CPT code 69730 which describes the revision/
replacement procedure with magnetic transcutaneous attachment resulting
in removal of greater than or equal to 100 square mm surface area of
bone. We did not agree that this would be typical and we believe that
the intensity would be more accurate at our proposed work RVU of 6.36.
We also noted in the proposed rule that the recommended work RVU of
7.50 for CPT code 69726 created a rank order anomaly within the family
as it would be higher than the recommended work RVU of 7.38 for CPT
code 69727 which describes a more complex procedure and has higher
surveyed work times. Commenters did not respond to our discussion of
the anomalously high intensity of CPT code 69727 at the recommended
work RVU or explain why it should create a rank order anomaly within
the family. As such, we continue to believe that the proposed work RVU
of 6.36 for CPT code 69726 is a more accurate choice than the RUC-
recommended work RVU of 7.50.
After consideration of the comments, we are finalizing the work
RVUs for all nine codes in the Transcutaneous Passive Implant-Temporal
Bone family as proposed. We did not receive any comments on the direct
PE inputs and we are also finalizing them as proposed.
(18) Contrast X-Ray of Knee Joint (CPT Code 73580)
CPT code 73580 (Radiologic examination, knee, arthrography,
radiological supervision and interpretation) was first identified via
the high-volume growth screen in 2008. In 2021, the Relativity
Assessment Workgroup (RAW) noted that code 73580 was never surveyed and
remains CMS/Other sourced, and recommended that it be surveyed. CPT
code 73580 was then surveyed. We proposed the RUC-recommended work RVU
of 0.59. We also proposed the RUC-recommended direct PE inputs without
refinement.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed the RUC-recommended work RVU of 0.59 for
CPT code 73580. We are finalizing as proposed the RUC-recommended
direct PE inputs without refinement.
(19) 3D Rendering With Interpretation and Report (CPT Code 76377)
We nominated this code in the CY 2020 PFS final rule as potentially
misvalued, stating that we believe it is of the same family as CPT code
76376 (3D rendering with interpretation and reporting of computed
tomography, magnetic resonance imaging, ultrasound, or other
tomographic modality with image postprocessing under concurrent
supervision; not requiring image postprocessing on an independent
workstation), which was reviewed at the April 2018 RUC meeting. CMS
requested that CPT code 76377 also be reviewed to maintain relativity
within the code family (84 FR 62625). The specialty societies maintain
that these services are more accurately viewed as separate code
families. Furthermore, the RUC cites changes in technique and patient
population as compelling evidence to maintain a physician work RVU of
0.79 despite a 5-minute recommended reduction in physician total time
compared to the current physician time.
We proposed the RUC recommended work RVU of 0.79 for CPT code
76377; however, we reiterate that we continue to believe that CPT code
76376 and 76377 would be more appropriately viewed as belonging to the
same code family and we request that they be surveyed together.
We proposed the RUC-recommended direct PE inputs without
refinement.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed the RUC-recommended work RVU of 0.79 for
CPT code 76377. We are finalizing as proposed the RUC-recommended
direct PE inputs without refinement.
(20) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
Since their creation in 2011, CPT codes 76881 (Ultrasound, complete
joint (i.e., joint space and peri-articular soft-tissue structures),
real-time with image documentation) and 76882 (Ultrasound, limited,
joint or other nonvascular extremity structure(s) (e.g., joint space,
peri-articular tendon[s], muscle[s], nerve[s], other soft-tissue
structure[s], or soft-tissue mass[es]), real-time with image
documentation) have been reviewed numerous times as New Technology/New
Services by the Relativity Assessment Workgroup (RAW). In October 2016,
the RAW reviewed these codes and agreed with the specialty societies
that the dominant specialties providing the complete (CPT code 76881)
versus the limited (CPT code 76882) ultrasound of extremity services
were different than originally thought, causing variation in the
typical PE inputs. The RAW recommended referral to the Practice Expense
Subcommittee for review of the direct PE inputs and the CPT Editorial
Panel to clarify the introductory language regarding the reference to
one joint in the complete ultrasound. The PE Subcommittee reviewed the
direct PE inputs for CPT codes 76881 and 76882 and adjusted the
clinical staff time at the January 2017 RUC meeting, and the CPT
Editorial Panel editorially revised CPT codes 76881 and 76882 to
clarify the distinction between complete and limited studies and
revised the introductory guidelines to clarify reference to one joint
in the complete ultrasound procedure in June 2017. In October 2021, the
CPT Editorial Panel approved the addition of CPT code 76883 for
reporting real-time, complete neuromuscular ultrasound of nerves and
accompanying structures throughout their anatomic course, per
extremity, and the revision of CPT code 76882 to add focal evaluation.
CPT codes 76881 and 76882 were identified as part of the neuromuscular
ultrasound code family with CPT code 76883 and surveyed for the January
2022 RUC meeting.
For CPT codes 76881, 76882, and 76883, we disagreed with the RUC-
recommended work RVUs of 0.90, 0.69, and 1.21, respectively, as we
believed they did not account for the surveyed time changes or
appropriate comparisons for the new add-on code, CPT code 76883, and
proposed a work RVU of 0.54 for CPT code 76881, a work RVU of 0.59 for
CPT code 76882, and a work RVU of 0.99 for CPT code 76883.
CPT code 76881 represents a complete evaluation of a specific joint
in an extremity. This service requires ultrasound examination of all
the following joint elements: joint space (for example, effusion),
peri-articular soft-tissue structures that surround the joint (that is,
muscles, tendons, other soft-tissue structures), and any identifiable
abnormality. In some circumstances, additional evaluations such as
dynamic imaging or stress maneuvers may be
[[Page 69507]]
performed as part of the complete evaluation. The RUC recommended 5
minutes of pre-service time, 20 minutes of intraservice time, and 5
minutes of post-service time, based on the survey. The RUC discussed
the 5-minute increase in intraservice time and determined that the
increase relates to the change in the dominant specialty provider since
the creation of the code, as previously there was 15 minutes of
intraservice time for the radiologist to scan and/or review the
sonographer-obtained images. Now, the rheumatologist is performing the
scanning and it takes 20 minutes for the typical patient. For
rheumatology, physicians typically scan the patients with portable
ultrasound devices rather than utilizing sonographers as originally
described in the 2010 survey. The RUC noted that this code is reported
with an office E/M visit 58.9 percent and a non-facility office E/M
visit 66.3 percent of the time; the RUC stated that CPT code 76881 is
imaging-specific so the physician work described would not overlap with
the E/M service, but we disagreed, as the descriptions of pre-service
and post-service work directly overlap. The description of pre-service
work for CPT code 76881 states ``Review pertinent clinical information.
Review any prior applicable imaging studies.'' Pre-service work for CPT
code 99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter.), the most common E/M
code reported with CPT code 76811, includes ``Review interval
correspondence, referral notes, medical records, and diagnostic data
generated since the last visit.'' Post-service work of CPT code 76881
is described as ``Discuss significant findings with the referring
physician. Review and sign final report,'' whereas the post-service
work for CPT code 99214 includes ``Arrange diagnostic testing and
referral if necessary. Document the encounter in the medical record,
spending time to further refine the differential diagnosis, workup, or
treatment plan as necessary. Coordinate care by discussing the case
with other physicians and members of the health care team and write
letters of referral if necessary. Perform electronic data capture and
reporting to comply with quality payment program and other electronic
mandates. Review and analyze interval testing results and refine the
differential diagnosis, workup, and treatment plan based on these
results. Order additional testing based on these results. Communicate
results and plan modifications with patient and/or family.'' We
believed there was overlap in pre-service and post-service work between
the E/M visit and CPT code 76881, and therefore, we proposed 0 minutes
for the pre-service and post-service time rather than the RUC-
recommended 5 minutes of pre-service and post-service time. The
proposed work RVU of 0.54 was the reverse building block valuation
based on the removal of the 5 minutes of pre-service and post-service
time, with a long-standing intensity of 0.0224 (10 minutes * 0.0224
work/minute = 0.224 work RVUs). The proposed work RVU accounted for the
0.224 work RVU decrease as a result of the removal of pre-service and
post-service time, and the increase of 5 minutes of intraservice time,
while maintaining the same IWPUT of 0.027, as there was no discussed
change in intensity. The specialty societies and the RUC asserted that
there was an increase of 5 minutes as a result of the intraservice work
changing due to a change in dominant specialty providing the service
(from radiology to rheumatology), but did not present a change in
intensity. We noted that the specialty societies used CPT code 76700
(Ultrasound, abdominal, real time with image documentation; complete)
with a work RVU = 0.81, 11 minutes of intra-service time, and 21
minutes total time, as a reference code because it has identical pre-
and post-service time but less intra-service time than the surveyed
code and is a clinically similar ultrasound code. We noted that this is
not an appropriate reference code as it is billed alone 72.8 percent of
the time, and therefore, the valuation of CPT code 76700 accounts for
pre- and post-service work that would not overlap with an E/M visit
like we believed the pre- and post-service work did for CPT code 76881.
CPT code 76882 represents a limited evaluation of a joint or focal
evaluation of a structure(s) in an extremity other than a joint (for
example, soft-tissue mass, fluid collection, or nerve[s]). This
evaluation includes assessment of a specific anatomic structure(s) (for
example, joint space only [effusion] or tendon, muscle, and/or other
soft-tissue structure[s] that surround the joint) that does not assess
all the elements included in CPT code 76881, although it does include
all surrounding anatomy and any associated pathology or contralateral
comparison as indicated. The RUC discussed the four-minute increase in
intraservice time and determined that the increase relates to the
change in dominant supplier of this service since the creation of the
code, as there is currently 11 minutes of intraservice time that
included scanning performed only by the podiatrist, and now the
radiologist works with the sonographer to obtain and interpret the
images in addition to the physician performing additional scanning as
needed. Because radiologists no longer use portable ultrasound devices
as originally described in the 2010 survey or in the 2017 PE update,
the RUC and specialty societies assert that the physician work (time)
has changed due to supervision of the sonographer in addition to the
radiologist performing the scanning. The specialty societies and RUC
also noted that ultrasound technology has evolved immensely since 2010,
including proliferation of high-frequency ultrasound probes dedicated
to musculoskeletal imaging, as well as producing images with higher
fidelity and more detail, whereby the number and quality of images that
can be reviewed and the pathology to evaluate have greatly increased
since 2010. Therefore, the typical patient requires 15 minutes of
intraservice time. While we agreed with the RUC that 15 minutes of
intraservice time is warranted for CPT code 76882, we noted that there
was no information indicating a change in intensity, and therefore, for
CPT code 76882, we proposed the reverse building block work RVU of 0.59
to account for the 4-minute increase in intraservice time and the
maintenance of the current IWPUT of 0.024.
We noted that commenters may raise concern about a potential rank
order anomaly with the proposed work RVUs of 0.54 and 0.59 for CPT
codes 76881 and 76882, respectively, but we noted that the IWPUT of
each code adequately reflects the increased intensity of intraservice
work for the complete ultrasound (CPT code 76881; IWPUT = 0.027) versus
the limited/focal ultrasound (CPT code 76882; IWPUT = 0.024), and the
lesser work RVU of 0.54 for CPT code 76881 stemmed from the removal of
the presumed overlapping pre- and post-service time with the E/M visits
that are typically performed. The RUC noted that consistency of
intensity measures is demonstrated across the range of codes ascending
from the limited code (CPT code 76881) to the new, most complex code
(CPT code 76883). By proposing work RVUs that maintain the current
IWPUTs, we maintained relativity both among the neuromuscular
ultrasound family, as well as the larger family of ultrasound
[[Page 69508]]
imaging codes. We also noted that the difference between the RUC-
recommend IWPUTs and our proposed IWPUTs for CPT codes 76881 and 76882
was the same, where CPT code 76882 had an IWPUT that is 0.003 less than
the IWPUT of CPT code 76881.
CPT code 76883 will be available for CY 2023 to report real-time,
complete neuromuscular ultrasound of nerves and accompanying structures
throughout their anatomic course, per extremity. This code will entail
examination of a nerve throughout its length, within one extremity,
including evaluation of multiple areas for potential nerve compression,
measurement of cross-sectional areas, evaluation of echogenicity,
vascularity, mobility including dynamic maneuvers when indicated,
evaluation for any associated muscular denervation, with comparison to
unaffected muscles or nerves within that extremity as needed. CPT code
76883 also requires permanently recorded images and cine loop and a
written report containing a description of each of the elements
evaluated. The RUC recommended 7 minutes of pre-service time, 25
minutes of intra-service time and 7 minutes of post-service time as
supported by the survey. The RUC clarified that this service would not
typically be reported with an office E/M visit. The RUC arrived at a
recommended work RVU of 1.21 by comparing the pre-, intra-, and post-
service times to those of CPT code 76881, which we proposed to modify
due to presumed overlapping work in the pre- and post-service time with
E/M visits. When we compared the proposed times of 0 minutes of pre-
service time, 20 minutes of intraservice time, and 0 minutes of post-
service time, and a work RVU of 0.54 for CPT code 76881, and the
proposed times of 7 minutes of pre-service time, 25 minutes of
intraservice time, and 7 minutes of post-service time for CPT code
76883, we arrived at a reverse building block work RVU of 0.99.
For the direct PE inputs, we proposed to remove the 2 minutes of
clinical labor time for CA006 (Confirm availability of prior images/
studies), the 1 minute of clinical labor time for the CA007 (Review
patient clinical extant information and questionnaire), and the 2
minutes for CA011 (Provide education/obtain consent) for CPT code 76881
because these RUC recommendations describe clinical labor activities
that presumably overlapped with the E/M visit that is typically billed
with CPT code 76881. We proposed the direct PE inputs as recommended by
the RUC for CPT codes 76882 and 76883.
We received several comments regarding our proposed work RVUs, pre-
and post-service time, and direct PE input refinements for CPT codes
76881, 76882, and 76883 in response to the CY 2023 PFS proposed rule
and those comments are summarized below.
Comment: Some commenters stated that the pre- and post-service work
of CPT code 76881 should not be removed simply because it may be billed
in conjunction with an E/M code. One commenter stated that if a
rheumatologist decides to order the more expensive MRI instead of
performing an ultrasound, the pre- and post- ordering time is quick,
whereas, for musculoskeletal ultrasound (MSKU), the pre-service time
includes detailed review of other studies and discussion with the
patient that are not normally included as part of the E/M visit. The
post-service work includes labelling, storing, documenting the results.
The commenter stated that none of this would be part of the normal E/M
coding for a visit. Another commenter stated that the physician work
associated with an E/M visit is separate and distinct from the
physician work associated with the imaging services reported by CPT
code 76882. Furthermore, the commenter asserted that the E/M visit and
ultrasound require different cognitive and technical skills by the
rendering physician. When these services are performed in the same
encounter, the physician work is neither overlapping nor duplicative,
and should be separately accounted for.
Response: After review of the commenters' statements, CPT code
76881's pre- and post-service descriptions, and similar imaging codes
that are typically reported with an E/M visit which allow for pre- and
post-service time, we agree with the commenters' assertion that the 5
minutes of pre- and post-service time is appropriate for CPT code
76881. We also agree that, while the service descriptions of the E/M
visit and CPT code 76881 may match, CPT code 76881's activities likely
reflect image-specific activities that do not overlap with the E/M
visit's activities; therefore, we are finalizing physician work time as
the RUC recommended, with 5 minutes of pre-service evaluation time and
5 minutes of immediate post-service time.
Comment: Some commenters stated that these CPT codes are typically
furnished by rheumatologists with the following direct PE inputs: (1)
expensive, high quality, high frequency ultrasound machines with power
Doppler capability rather than an inexpensive, handheld/portable device
as included in the direct PE inputs; (2) a sonographer specially
trained in MSKU rather than a physician or a standard x-ray technician
as included in the direct PE inputs; and (3) a dedicated exam/imaging
room in which to perform this service. One commenter submitted
responses and synthesized conclusions from a limited survey of direct
PE inputs typical of rheumatologists. More commenters noted that the
RUC decided to reduce the PE portion of the technical component of CPT
code 76881 by over 90 percent, phased in over time. The commenters
continued by stating that there is another proposed decrease to 0.27 PE
RVUs for CY 2023 based on a flawed assumption regarding the type of
ultrasound services provided in the non-facility setting. The
commenters stated that many clinics maintain and use a dedicated
ultrasound room, a non-portable ultrasound room and a PACS system, as
well as two dedicated sonographers. The commenters stated that even
practices that use portable ultrasound units will utilize a dedicated
ultrasound room and PACS system, and employ, or contract the services
of, a sonographer or other highly trained, typically highly
credentialed, clinical staff. One commenter stated that the January
2022 RUC recommendations indicate rheumatology as the dominant
specialty in the non-facility setting, but they incorrectly assumed
that portable ultrasound is the typical equipment used by
rheumatologists. This commenter stated that, of the 88 providers who
submitted surveys for CPT code 76881 or the 100 providers that
submitted surveys for CPT code 76882, no information was provided
regarding the level of rheumatologists' input, and therefore, the
commenter asserted that there is no way of knowing if rheumatologists
were appropriately queried, despite the acknowledgement that they are
the dominant specialty for CPT code 76881. This commenter submitted an
attachment that claims that the dedicated medical sonographer's labor
cost per hour is $47.50 and that they spent $80,017.24 on ultrasound
technology and $3,003.00 in maintenance of the ultrasound technology
per year. Another commenter stated that rheumatology was not part of
the PE survey in 2017 and none of the RUC members who sat on the PE
subcommittee in 2017 performed MSKU in their offices at the time of the
survey. The commenter stated that we stated that the ``transition
period [to phase in the cuts year over year as finalized for CY 2018]
would allow us to obtain more stakeholder input on the appropriate PE
inputs and specialty assumptions for these
[[Page 69509]]
services,'' and that we expected to consider this for future
rulemaking. The commenter noted that their comments on the CY 2019 PFS
proposed rule were deemed out of scope and that no further action was
taken to obtain PE values.
Response: We appreciate the commenters' survey collection efforts
to reflect rheumatologists' costs in performing CPT codes 76881, 76882,
and 76883, and the concern regarding the accounting of rheumatologists'
typical clinal labor and equipment in the January 2022 RUC
recommendations. We share the commenters concerns that the recommended
PE inputs may not fit within the family of services as currently valued
given concerns raised by commenters. In consideration of commenters'
concerns and survey data, including early feedback on how the PE inputs
for these services may not be reflective of what will be considered
typical in how these services may be furnished, we encourage the RUC
and other interested parties to reconsider the PE inputs of the
neuromuscular ultrasound family, including the new code, in the near
term.
We note that we did not make any proposals related to CPT codes
76881 or 76882 in the CY 2019 PFS proposed rule, therefore the comments
were appropriately deemed out of scope at that time, and at that time,
rheumatology was not the dominant specialty, therefore, we would have
considered PE inputs of the dominant specialty to be typical when
performing these CPT codes at that time. We encourage the commenters to
coordinate with the RUC to provide the survey data to facilitate a
reconsideration of PE inputs given the shift in dominant specialty and
recent changes that were made by the RUC PE Subcommittee.
Because the RUC has standardized procedures for PE and physician
surveys, and the fact that the surveyors' results differ so drastically
from the RUC recommendations, we encourage the RUC and other interested
parties to reconsider the PE inputs of the neuromuscular ultrasound
family, which we would consider in future rulemaking if submitted.
While the submission of the survey data is appreciated, we note that no
invoices were submitted, and therefore, we encourage collaboration with
the RUC PE subcommittee and the submission of specific invoices to
support the surveys' results and robust data to show the typicality of
these PE inputs.
Comment: One commenter asserted that they utilize a dedicated
diagnostic medical sonographer with specific musculoskeletal training,
high quality machines that cost around $40 thousand each (based on a
recent purchase of a GE LOGIQTM E ultrasound machine for a
Veteran Affairs Hospital that cost $44,110 after a government
discount), and a dedicated ultrasound scanning room due to patient
draping requirements and machine optimization.
Response: We appreciate the commenters' input regarding CPT codes
76881, 76882, and 76883. We encourage the RUC and other interested
parties to reconsider the PE inputs of the neuromuscular ultrasound
family, as they differ significantly from the RUC recommended direct PE
inputs as submitted for the CY 2023 PFS proposed rule. After a
reconsideration by the RUC and interested parties regarding the PE
inputs, we would be interested in engaging with interested parties to
obtain invoices to support accurate pricing for PE inputs that may be
altered for this family of codes.
Comment: Many commenters urged CMS to pause all proposed reductions
to CPT codes 76881 and 76882 to allow collaboration between the RUC and
interested parties' on how rheumatologists currently utilize or plan to
utilize MSKU since the rheumatology community has never been surveyed
by the RUC on their typical PE investments in their ultrasound
programs. Commenters stated that rheumatologists were not included in
the 2017 survey when PE cuts were recommended by the RUC and finalized
for CY 2018.
Response: We believe it is imperative that the RUC and interested
parties reconsider the PE inputs for CPT codes 76881, 76882, and 76883
in the near term, as commenters have submitted survey responses that
differ significantly from the RUC recommended direct PE inputs. There
are also significant discrepancies between the RUC assumption that
rheumatologists typically scan patients themselves, versus varying
commenters agreeing with this assumption, and some arguing that
rheumatologists utilize a highly trained sonographer to scan patients.
There are also significant commenter and RUC discrepancies regarding
typical equipment used for these CPT codes. We note that in the CY 2018
PFS final rule (82 FR 53058 through 53059), we sought comment on
whether a portable ultrasound unit would be a more accurate PE input
for CPT codes 76881 and 76882, given that the dominant specialty for
both of these services was podiatry based on available 2016 Medicare
claims data. At that time, we did not finalize our proposal to include
an ultrasound room, and instead finalized the RUC recommended
equipment, with the exception of the ultrasound room, which we replaced
with a portable ultrasound unit based on the RUC's determination, as
expressed through its recommendations for CY 2018, that a portable unit
is the equipment type that is typical for podiatry, which was the
dominant specialty furnishing CPT code 76882 at the time. Commenters
disagreed with our proposals and RUC recommendations, stating that the
shift of PE from CPT code 76881 to CPT code 76882 was based on
inaccurate assumptions regarding the typical equipment used in
furnishing these services. These commenters noted that the equipment
used to furnish the two procedures is identical and that the RUC-
recommended direct PE inputs for CPT code 76881, which were developed
based on the assumption that the dominant specialty furnishing the
service is podiatry, do not reflect the equipment inputs utilized by
rheumatologists such as an ultrasound room and PACS workstation. Given
the changes in dominant specialty for these CPT codes from 2010 to
2017, and again from 2017 to 2022, we recommend that the RUC and
interested parties reconsider the PE inputs for each code based on the
dominant specialty for each CPT code, based on the most recent year's
Medicare claims data, and consideration of survey responses submitted
to CMS in response to the CY 2023 PFS proposed rule.
Comment: Many commenters expressed the importance of MSKU in
controlling the prescribing of expensive biologic medications,
streamlining patient care, reducing delays in patient care that result
from scheduling alternative imaging tests (not on the initial
encounter) and subsequent follow up visits to act on the tests results,
and obtaining sensitive, safe non-traumatic images for pediatric
patients. Commenters stated that MSKU benefits patients and families by
allowing them to see their anatomy in real time, which aids the
patients' confidence in their physician and diagnosis. Commenters also
stated that MSKU aids minorities and underserved areas where access to
MSKU extends the ability to care for patients who may otherwise not be
able to travel for MRI or CT services due to cost or additional time
required to schedule and attend subsequent visits for the imaging and
follow up, which can extend the time to initiate treatment by months.
Response: We appreciate the commenters' input on the value of CPT
codes 76881, 76882, and 76883, and agree with the commenters that these
services play an integral part in high
[[Page 69510]]
quality, cost effective, expedient imaging, diagnosis, and care for a
variety of patient populations. For this reason, we believe it is
imperative that the RUC and interested parties reconsider the PE inputs
for CPT codes 76881, 76882, and 76883 in the near term.
In order to maintain relativity among this family of codes after
being compelled by the commenters' assertion that the pre- and post-
service time for CPT code 76881 does not overlap with an E/M visit, and
finalizing the RUC-recommended work RVU and PE inputs for CPT code
76881, we are also finalizing the RUC recommended work RVUs and PE
inputs for CPT codes 76882 and 76883. Therefore, for CPT codes 76881,
76882, and 76883, we are finalizing work RVUs of 0.90, 0.69, and 1.21,
respectively. As mentioned above, we are finalizing 5 minutes of pre-
service evaluation time and 5 minutes of immediate post-service time
for CPT code 76881. Similarly, we are finalizing the inclusion of 2
minutes of clinical labor time for CA006 (Confirm availability of prior
images/studies), 1 minute of clinical labor time for the CA007 (Review
patient clinical extant information and questionnaire), and 2 minutes
for CA011 (Provide education/obtain consent) for CPT code 76881 for the
direct PE inputs, as recommended by the RUC, because we are compelled
by the commenters' assertion that these activities are imaging-specific
and do not overlap with an E/M visit. We are finalizing the direct PE
inputs as recommended by the RUC for CPT codes 76882 and 76883, as
proposed. We reiterate our recommendation that the RUC and interested
parties reconsider the PE inputs in the near term. We also remind
interested parties that we have established an annual process for the
public nomination of potentially misvalued codes. This process provides
an annual means for those who believe that values for individual
services are inaccurate and should be readdressed through notice and
comment rulemaking to bring those codes to our attention, as detailed
in section II.C. of this final rule. As part of our current process, we
identify potentially misvalued codes for review, and request
recommendations from the RUC and other public commenters on revised
work RVUs and direct PE inputs for those codes. While this process is
available to interested parties, we encourage the RUC and other
interested parties to reconsider the PE inputs of the neuromuscular
ultrasound family as a whole, including the new code, in the near term,
as we have already reviewed comments for this final rule and survey
data that may indicate that the PE inputs for these services may not be
reflective of what will be considered typical in how these services may
be furnished.
(21) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472,
90473, and 90474)
Especially in the context of the current PHE for COVID-19, it is
evident that consistent beneficiary access to vaccinations is vital to
public health. As discussed in the CY 2021 PFS proposed rule (85 CFR
50162), many interested parties raised concerns about the reductions in
payment rates for the preventive vaccine administration services that
had occurred over the past several years. The codes for immunization
administration services include CPT codes 90460, 90471, and 90473, as
well as the three Healthcare Common Procedural Coding System (HCPCS)
codes that describe the services to administer the Part B preventive
vaccinations other than the COVID-19 vaccine: G0008 (influenza), G0009
(pneumococcal), and G0010 (HBV). Until CY 2019, we generally had
established payment rates for these immunization administration
services based on a direct crosswalk to the PFS payment rate for CPT
code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular). Because we proposed
and finalized reductions in valuation for the crosswalk code for CY
2018, and because the reductions in overall valuation for that code
have been subject to the multi-year phase-in of significant reductions
in RVUs, the payment rate for these vaccine administration codes has
been concurrently reduced. Further, because the reduction in RVUs for
the crosswalk code, CPT code 96372, was significant enough to be
required to be phased in over several years under section 1848(c)(7) of
the Act, the reductions in overall valuation for the vaccine
administration codes were likewise subject to reductions over several
years. As we noted in Table 21 of the CY 2022 PFS proposed rule (86 FR
39222), the national payment rate for administering these preventive
vaccines has declined more than 30 percent since 2015.
We have attempted to address the reduction in payment rates for the
Part B preventive vaccine administration HCPCS G-codes in the last
three PFS rulemaking cycles. In the CY 2020 PFS final rule, we
acknowledged that it is in the public interest to ensure appropriate
resource costs are reflected in the valuation of the immunization
administration services that are used to deliver these vaccines, and
noted that we planned to review the valuations for these services in
future rulemaking. For CY 2020, we maintained the CY 2019 national
payment amount for immunization administration services described by
HCPCS codes G0008, G0009 and G0010 (84 FR 62798).
In the CY 2021 PFS proposed rule, we proposed to crosswalk CPT
codes 90460, 90471, and 90473, as well as HCPCS codes G0008, G0009 and
G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein)
(85 FR 50163). In the proposed rule, we noted that CPT code 36000 is a
service with a similar clinical vignette, and that the additional
clinical labor, supply, and equipment resources associated with
furnishing CPT code 36000 were similar to costs associated with these
vaccine administration codes. We also noted that this crosswalk would
have resulted in a payment rate for vaccine administration services
that is approximately the same as the CY 2017 rate that was in place
prior to the revaluation of CPT code 96372 (the original crosswalk
code). In the CY 2021 PFS final rule, we did not finalize the proposed
policy, and instead finalized a policy to maintain the CY 2019 payment
amount for CPT codes 90460-90474, as well as HCPCS codes G0008, G0009
and G0010 (85 FR 84628). In the final rule, we also noted that we
continued to seek additional information that specifically identifies
the resource costs and inputs that should be considered to establish
payment for vaccine administration services on a long-term basis.
For the CY 2022 rulemaking cycle, we requested feedback from
interested parties that would support the development of an accurate
and stable payment rate for administration of the preventive vaccines
described in section 1861(s)(10) of the Act (influenza, pneumococcal,
HBV, and COVID-19) for physicians, NPPs, mass immunizers and certain
other providers and suppliers. We invited commenters to submit their
detailed feedback to a series of questions and requests that we
believed would assist us in establishing payment rates for these
services that could be appropriate for use on a long-term basis; we
direct readers to the full discussion of this topic in the CY 2022 PFS
final rule (86 FR 65179 through 65193). For CY 2022, we finalized a
uniform payment rate of $30 for the administration of an influenza,
pneumococcal or HBV vaccine covered under the Medicare Part B
preventive vaccine benefit at section 1861(s)(10) of the Act. We
explained that since the
[[Page 69511]]
administration of the preventive vaccines described under section
1861(s)(10) of the Act is not included within the statutory definition
of physicians' services, the payment rates we established for these
services in the CY 2022 PFS final rule are independent of the PFS, and
will be updated as necessary independently of the valuation of any
specific codes under the PFS (86 FR 65186). We discuss the current
payment policy for administration of preventive vaccines and our
proposals for CY 2023 in section II.H. of this final rule.
We note that as we considered payment policies to ensure adequate
access to the Part B preventive vaccines, including consideration of
resource costs, the RUC surveyed and reviewed CPT codes 90460-90474 at
the April 2021 meeting and submitted recommendations to CMS for our
consideration in the CY 2023 rulemaking cycle.
We proposed the RUC-recommended work RVU for all six codes in the
Immunization Administration family. We proposed a work RVU of 0.24 for
CPT code 90460 (Immunization administration through 18 years of age via
any route of administration, with counseling by physician or other
qualified health care professional; first or only component of each
vaccine or toxoid administered), a work RVU of 0.18 for CPT code 90461
(Immunization administration through 18 years of age via any route of
administration, with counseling by physician or other qualified health
care professional; each additional vaccine or toxoid component
administered), a work RVU of 0.17 for CPT code 90471 (Immunization
administration (includes percutaneous, intradermal, subcutaneous, or
intramuscular injections); 1 vaccine (single or combination vaccine/
toxoid)), a work RVU of 0.15 for CPT code 90472 (Immunization
administration (includes percutaneous, intradermal, subcutaneous, or
intramuscular injections); each additional vaccine (single or
combination vaccine/toxoid)), a work RVU of 0.17 for CPT code 90473
(Immunization administration by intranasal or oral route; 1 vaccine
(single or combination vaccine/toxoid)), and a work RVU of 0.15 for CPT
code 90474 (Immunization administration by intranasal or oral route;
each additional vaccine (single or combination vaccine/toxoid)).
For the direct PE inputs, we proposed to remove 1 minute of
clinical labor time for the CA008 (Perform regulatory mandated quality
assurance activity (pre-service)) activity for CPT codes 90460 and
90471-90474. The RUC recommendations describe these activities as
``Checking historical and current temperatures for vaccine
refrigerator; recording temperatures; reporting temperatures; vaccine
inventorying; ordering vaccines; completing required Vaccines for
Children (VFC) paperwork; receiving vaccines; inspecting/logging
vaccines and putting them in the vaccine refrigerator; creating lot
numbers in EHR.'' Checking refrigerator temperatures, vaccine
inventorying, and filling out vaccine paperwork are administrative
tasks which are not individually allocable to a particular patient for
a particular service. We removed this 1 minute of clinical labor time
as these administrative tasks are forms of indirect PE. We also refined
the equipment times for CPT codes 90460 and 90471-90474 to conform to
our established policies for non-highly technical equipment.
In consideration of the information provided in the recommendation
for these services, we proposed the RUC's recommended work RVUs and
direct PE inputs (with minor refinements) for these vaccine
administration services. However, we continue to seek additional
information from commenters that specifically identifies the resource
costs and inputs that should be considered to establish payment for
these vaccine administration services on a long-term basis, consistent
with our policy objectives for ensuring maximum access to immunization
services.
Comment: Many commenters stated that they supported the proposal of
the RUC-recommended work RVUs for all six codes in the Immunization
Administration family.
Response: We appreciate the support for our proposed work RVUs from
the commenters.
Comment: A commenter stated that they supported the proposal of the
RUC-recommended work RVUs and thanked CMS for its emphasis on the
importance and value of vaccines. The commenter also stated that CMS
should adopt a site-neutral approach for all Part B vaccines and apply
the OPPS payment rate in all sites of service. The commenter stated
that the vaccine administration service is remarkably similar across
all of the intramuscular injected Part B vaccines; the commenter stated
that it is essentially the same service regardless of the type of
vaccine, across all of the various sites of service and that the
infrastructure and necessary supplies and staff are fundamentally the
same regardless of where a vaccine is administered. The commenter
stated that annual updates to the vaccine administration payment rates
based on OPPS claims data is a reliable and data-based method for
updating the payment rate which would prevent the issues that have
occurred in the past with the crosswalk to CPT code 96372.
Response: We appreciate the support for our proposed work RVUs from
the commenter. We did not propose and we are not finalizing the OPPS
payment rates for the Immunization Administration codes as we do not
have data at the moment that indicates these services are identical
regardless of the site of service and type of provider. We note for the
commenter that we proposed work RVUs and direct PE inputs for the
Immunization Administration codes to ensure that they would be
resource-based and not dependent on crosswalks to other CPT codes for
valuation.
Comment: One commenter disagreed with the proposed valuation of the
Immunization Administration codes and stated that the proposed payment
rates were insufficient to cover the resource costs associated with
providing these services. The commenter stated that the RUC methodology
does not result in adequate payment rates for these vaccine
administration services and requested that CMS assign the $30 Part B
vaccine administration payment rate to the Part D vaccine
administration services as well. The commenter stated that there was no
policy rationale for a large difference in payment rates between the
proposed Part B vaccine administration payment rate and the proposed
payments rates for the Part D vaccine administration services and
requested that CMS finalize a payment of $30 for CPT codes 90460,
90461, 90471, 90472, 90473, and 90474.
Response: We disagree with the commenter that the RUC methodology
used to value the Immunization Administration codes does not result in
adequate payment rates for these services. We remind the commenter that
under Medicare Part B, the statute requires CMS to value physician
services using a resource-based system based on the time and intensity
of the services involved. (See section 1848(c)(1)(A) of the Act.) We
believe that the RUC recommended values for these codes, with minor
refinements to the direct PE inputs to conform with our standard
equipment time methodology, are reasonable and will establish resource-
based payments for these services as required by the statute.
Comment: Several commenters disagreed with the proposal to remove 1
minute of clinical labor time for the CA008 (Perform regulatory
mandated
[[Page 69512]]
quality assurance activity (pre-service)) activity for CPT codes 90460
and 90471-90474 as a form of indirect PE. Commenters stated that
clinical staff immunization confirmation protocols have changed since
the Immunization Administration codes were last valued due to the
explosion in the number of new vaccines introduced since 2009.
Commenters stated that practitioners typically give orders for the
antigen but not the particular brand and presentation, and determining
which of these vaccine products to use is a clinical staff decision
based on the patient's age and vaccination history and potentially
complicated by restrictions. Commenters stated that some vaccines have
different dosing requirements based on age, and that while in some
cases it is acceptable to use the alternative brand in stock if the
original brand is not known, in other cases using only the brand from
the original dose is acceptable. Commenters stated that each time a
vaccine is administered clinical staff must follow these immunization
confirmation protocols, and therefore, the commenters believe that
these clinical staff activities are appropriately attributed to direct
PE.
Response: We appreciate the additional information provided by the
commenters describing the decisions that the clinical staff must make
when carrying out these regulatory mandated quality assurance
activities. Based on this additional information, we agree that these
quality assurance activities constitute a form of clinical judgment
that is individually allocable to the Immunization Administrative
services as a form of direct PE. We are therefore not finalizing our
proposal and will restore the 1 minute of clinical labor time for the
CA008 activity for CPT codes 90460 and 90471-90474.
Comment: Several commenters disagreed with the proposal to refine
the equipment times for CPT codes 90460 and 90471-90474 to conform to
the established CMS policies for non-highly technical equipment.
Commenters stated that in February 2008, the RUC recommended and CMS
finalized the use of total clinical staff time as the time of medical
equipment use for the service of vaccine administration. Commenters
stated that this established an exemption specific to the service of
vaccine administration and that CMS should finalize the RUC's equipment
time recommendations for each piece of medical equipment as established
by this 2008 exemption.
Response: We disagree with the commenters and continue to believe
that the equipment times for CPT codes 90460 and 90471-90474 should
conform to the established policies for non-highly technical equipment.
While the commenters are correct that we finalized the RUC-recommended
direct PE inputs for these codes in the CY 2009 PFS final rule (73 FR
69736), we did not establish an exemption to the standard equipment
times for the Immunization Administration codes. We did not apply the
established policies for non-highly technical equipment during our CY
2009 review of these codes solely because those established policies
had not been developed yet; the higher equipment times for CPT codes
90460 and 90471-90474 are an artifact of the age of their last review
date, not an exemption to our standard policies. As we have noted with
regards to the standardization of clinical labor tasks, we believe that
setting and maintaining standard equipment time formulas helps provide
greater consistency among codes and improves relativity across the
wider fee schedule. Updating older equipment times and bringing them
into accordance with the established equipment time formulas is a
standard part of our review process and the Immunization Administration
codes are no exception to that rule. We continue to believe that the
equipment times for CPT codes 90460 and 90471-90474 should conform to
the established policies for non-highly technical equipment in order to
maintain relativity between codes.
After consideration of the comments, we are finalizing the work
RVUs inputs for all six codes in the Immunization Administration family
as proposed. We are finalizing the direct PE inputs as proposed aside
from restoring 1 minute of clinical labor time for the CA008 activity
for CPT codes 90460 and 90471-90474 as described above.
(22) Orthoptic Training (CPT Codes 92065 and 92066)
In October 2019, the RUC identified CPT code 92065 (Orthoptic and/
or pleoptic training, with continuing medical direction and evaluation;
performed by a physician or other qualified health care professional)
as needing review because it was Harvard Valued (that is, the value of
the code had not been reviewed since the implementation of the
Resource-Based Relative Value Scale (RBRVS)) and its utilization
surpassed 30,000 in each of several recent years. At its January 2020
meeting, during review of CPT code 92065, the RUC noted that the use of
``and/or'' in the descriptor defined different patient populations and
treatment techniques and recommended that the code be reviewed by the
CPT Editorial Panel (CPT) in order to create two separate codes.
Additionally, based upon review and analysis of survey data, specialty
societies decided to submit a new code change application for the
February 2021 CPT meeting.
During the February 2021 meeting, CPT noted that the services of
CPT code 92065 are delivered in two different ways: directly by the
practitioner and by a technician under the supervision of the
practitioner. In response to this observation, CPT suggested that two
codes be created to identify who furnishes the orthoptic service.
Identifying in the code descriptor who furnishes the services would
ensure more accurate valuation of both the work and the PE associated
with the service. The CPT formally revised code 92065 and created new
CPT code 92066 to describe orthoptic services furnished under the
supervision of a physician or qualified health care professional.
During its April 2021 meeting, the RUC revalued the work associated
with the services of CPT code 92065 (Orthoptic training; performed by a
physician or other qualified health care professional) and valued the
PE inputs for new CPT code 92066 (Orthoptic training; performed by a
physician or other qualified health care professional under supervision
of a physician or other qualified health care professional). CPT code
92066 is valued as a PE-only code.
After reviewing CPT code 92065, we proposed to accept the RUC-
recommended work RVU of 0.71. We also proposed to accept the RUC-
recommended direct PE inputs for CPT code 92065. We proposed to accept
the RUC-recommended direct PE inputs for CPT code 92066 as well.
Comment: We received a few comments in response to our proposals
for CPT codes 92065 and 92066. Commenters expressed support of our
proposal to accept the RUC-recommended work RVUs and the direct PE
inputs adjustments.
Response: We thank commenters for taking time to submit their
support of the RUC-recommendations for CPT codes 92065 and 92066.
We are finalizing the RUC-recommended work RVU of 0.71 for CPT
codes 92065 and the RUC-recommended direct PE inputs for both CPT codes
92065 and 92066.
(23) Dark Adaptation Eye Exam (CPT Code 92284)
CPT code 92284 (Dark adaptation examination with interpretation and
report) was identified in July 2020 as Harvard Valued with a
utilization of over 30,000 claims. In January 2021, the
[[Page 69513]]
RUC recommended that the code be surveyed for the April 2021 RUC
meeting. The RUC reviewed the survey results for the procedure and
noted that the 25th percentile work value of 0.45 was greater than the
code's current value. The RUC recommended a work RVU of 0.14, based on
a direct work RVU crosswalk from CPT code 76514 (Ophthalmic ultrasound,
diagnostic; corneal pachymetry, unilateral or bilateral (determination
of corneal thickness)). We disagreed with the RUC-recommended work RVU
of 0.14 for CPT code 92284. We found that the recommended work RVU did
not adequately reflect reductions in physician time, since this
diagnostic screening is usually completed during an E/M visit and
largely consists of interpreting machine generated results. Instead, we
proposed a work RVU of 0.00 for CPT code 92284, which is comparable to
other ophthalmic screening tests; such as 99172 (Visual function
screening, automated or semi-automated bilateral quantitative
determination of visual acuity, ocular alignment, color vision by
pseudoisochromatic plates, and field of vision (may include all or some
screening of the determination[s] for contrast sensitivity, vision
under glare)) and 99173 (Screening test of visual acuity, quantitative,
bilateral). Alternatively, we considered using a total-time methodology
with a work RVU of 0.03 and a reverse building block methodology with a
work RVU of 0.06. We solicited comments and requested information that
may inform why CPT code 92284 should include additional valuation as
this procedure is included in an E/M visit.
For the direct PE inputs, we proposed to refine the equipment time
for the lens set (EQ165) from 24 minutes to 15 minutes and motorized
table (EF030) from 24 minutes to 15 minutes. The reduction in time for
both equipment types is proposed to match the RUC-recommended 15
minutes in Clinical Activity Code CA021. We solicited public comment to
provide further rationale for the additional 9 minutes recommended.
We received a few comments regarding our proposed work RVUs and
direct PE inputs for CPT code 92284 in response to the CY 2023 PFS
proposed rule and those comments are summarized below.
Comment: Commenters disagreed with the comparison to CPT codes
99172 and 99173, stating that these reference codes assume there is no
physician work involved with the service, and therefore, do not serve
as appropriate clinical comparisons to the surveyed CPT code 92284.
Instead, these commenters agree with the RUC-recommended crosswalk to
CPT code 76514 as a closer clinical comparison, based on work RVU,
intra-service time, and intensity of physician/optometrist work
involved with this service.
Commenters did not support the proposed alternative methodologies,
stating that the total-time and reverse building block methodologies do
not appropriately value the physician work and total time required in
CPT code 92284. In addition, the commenters stated that use of these
alternative methodologies would mean that we are choosing an
inconsistent combination of inputs to apply, and that this selection
process has the appearance of seeking an arbitrary value from the vast
array of possible mathematical calculations, rather than seeking a
valid, clinically relevant relationship that would preserve relativity.
One commenter acknowledged that we noted the physician work largely
consists of interpreting machine-generated results, stating that they
agreed with the RUC-recommended intraservice time of 3 minutes, which
was a reduction from the surveyed intraservice time of 15 minutes. The
commenter noted that this represents a change in technology which
allows technicians to administer the test, a change with which most
survey respondents were not familiar. Another commenter asked that we
consider upholding the RUC recommendations for all CPT codes covered in
this rule, especially CPT code 92284.
Response: We disagree with commenters and continue to believe that
CPT codes 99172 and 99173 are appropriate comparator codes for CPT code
92284. These reference codes also account for the screening nature of
CPT code 92284, which is usually performed in conjunction with an E/M
visit that accounts for the physician work. We continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
We also clarify for the commenters that our review process is not
arbitrary in nature and includes a variety of methodologies and
approaches used to develop work RVUs, including the use of building
block and total-time methodologies. Our reviews of recommended work
RVUs and time inputs generally include, but have not been limited to, a
review of information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the Federal
Government, as well as Medicare claims data.
When considering the intraservice time, we do not agree with the
commenter, and continue to believe that complex work is not performed
to analyze the machine generated results. In our review, we focus on
evaluating and addressing the time and intensity of services, but we
are under no obligation to adopt the same review process or compelling
evidence criteria as the RUC. While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. We also have reason to believe that the new
technology has led to greater efficiencies in the service which, under
the resource-based nature of the RVU system, lends further support for
a reduction in the work RVU.
Comment: Commenters urged CMS to accept the RUC-recommended direct
PE inputs for CPT code 92284 and provided additional rationale to
explain the additional 9 minutes of equipment time for the lens set
(EQ165) and motorized table (EF030). Commenters stated that in addition
to the 15 minutes that the equipment is in use during performance of
the test, there is an additional 9 minutes of clinical activities where
the equipment is unavailable for use with another patient. These
activities all occur in the room with the testing equipment, lens set,
and table.
Response: We appreciate the additional information provided by the
commenters to clarify the equipment time. We are persuaded by the
comments that explained the standard default equipment formula was used
and RUC PE direct input benchmarks for clinical staff time were used
for CA011, CA013, CA014, and CA024, which results in 24 minutes when
combined with the 15 minutes of CA021. Therefore, we are not finalizing
our proposed refinement to the equipment time for the lens set (EQ165)
and motorized table (EF030), and will finalize the RUC-recommended time
of 24 minutes.
After careful consideration of the public comments, we are
finalizing a work RVU of 0.00 for CPT code 92284 as proposed. For the
direct PE inputs,
[[Page 69514]]
we are not finalizing our proposed refinements to the equipment time
and are instead finalizing the RUC-recommended direct PE inputs for CPT
code 92284.
(24) Anterior Segment Imaging (CPT Code 92287)
For CPT code 99287 (Anterior segment imaging with interpretation
and report; with fluorescein angiography), we proposed the RUC-
recommended work RVU of 0.40.
We proposed the RUC-recommended direct PE inputs for CPT code 92287
without refinement.
Comment: Commenters supported our proposed valuation for CPT code
92287.
Response: We acknowledge and appreciate the support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.40 and the RUC-recommended direct PE
inputs for CPT code 92287 as proposed.
(25) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243,
93244, 93245, 93246, 93247, and 93248)
In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to
adopt the RUC's work RVU recommendations for CPT codes 93241 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation), 93242 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93243 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93244 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation),
93245 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; includes
recording, scanning analysis with report, review and interpretation),
93246 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; recording
(includes connection and initial recording)), 93247 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; scanning analysis with
report), and 93248 (External electrocardiographic recording for more
than 7 days up to 15 days by continuous rhythm recording and storage;
review and interpretation).
We noted that the recommendations for this family of codes
contained one new supply item, the ``extended external ECG patch,
medical magnetic tape recorder'' (SD339). We did not receive a
traditional invoice to establish a price for this supply item. Instead,
we received pricing information from two sources: a weighted median of
claims data with the cost of the other direct PE inputs removed, and a
top-down approach calculating the cost of the supply per service based
on summing the total costs of the health care provider and dividing by
the total number of tests furnished. The former methodology yielded a
supply price of approximately $440 while the latter methodology
produced an estimated supply price of $416.85. Interested parties also
submitted a series of invoices from the clinical study marketplace with
a price of $595, which we rejected as we typically require an invoice
representative of commercial market pricing to establish a national
price for a new supply or equipment item.
After consideration of the information, we proposed to employ a
crosswalk to an existing supply for use as a proxy price until we
received pricing information to use for the ``extended external ECG
patch, medical magnetic tape recorder'' item. We proposed to use the
``kit, percutaneous neuro test stimulation'' (SA022) supply as our
proxy item at a price of $413.24. We believed the kit to be the closest
match from a pricing perspective to employ as a proxy until we would be
able to arrive at an invoice that is representative of commercial
market pricing. We welcomed the submission of invoices or other
additional information for use in pricing the ``extended external ECG
patch, medical magnetic tape recorder'' supply. In response to our
proposal, we received conflicting information from commenters and in
the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized
contractor pricing for CY 2021 for the four codes that included this
supply input (CPT codes 93241, 93243, 93245, and 93247) to allow
additional time to receive more pricing information.
We noted that interested parties have continued to engage with CMS
and the MACs on payment for this service. We remained concerned that we
continued to hear that the supply costs as initially considered in our
CY 2021 PFS proposal were much higher than they should be. At the same
time, we also heard that the resource costs, as reflected in the
contractor-based payments, do not adequately cover the incurred cost
for the SD339 supply that is used to furnish these services. In
consideration of continued access to these services for Medicare
beneficiaries, we once again solicited public comments and information
in the CY 2022 PFS proposed rule (86 FR 39179) to support CMS' future
rulemaking to establish a uniform national payment that appropriately
reflects the PE inputs that are used to furnish these services. During
the comment period, we received invoices and additional information for
use in pricing the SD339 supply from the commenters.
Based on this information, we finalized an updated price of $200.15
for the ``extended external ECG patch, medical magnetic tape recorder''
(SD339) supply in the CY 2022 PFS final rule based on the average of
the ten invoices we received (86 FR 65125). We believed that the
invoice data for this supply item, which ranged from a minimum price of
$179.80 to a maximum price of $241.99, suggested that our updated price
of $200.15 was more accurate than the suggested crosswalk to the SD214
supply at a price of $325.98. We believed that considering a potential
impact to payment for other services under the PFS, a proposal to
establish national payment for these services based on this new pricing
information should take into account broader feedback from interested
parties. Therefore, we did not finalize national pricing at this time
and finalized our proposal to maintain contractor pricing for CPT codes
93241, 93243, 93245, and 93247 for CY 2022.
For CY 2023, we received a series of additional invoices for the
SD339 supply from two impacted parties. Each of the invoices priced the
supply item at either $265.00 or $226.38; we therefore proposed to
average together these prices and establish a proposed price of $245.69
for the SD339 supply. We noted that we believe that this represents the
most typical price for the supply based on the invoice data that has
been provided over the past 2 years. We also proposed national pricing
for CPT codes 93241, 93243, 93245, and 93247 for CY 2023 now that the
SD339 supply has an established price. The proposed CY 2023 RVUs for
these CPT codes are displayed in Addendum B on the CMS website under
downloads for the CY 2023 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Comment: Many commenters stated their support for the proposal of
national pricing for CPT codes 93241,
[[Page 69515]]
93243, 93245, and 93247. Commenters detailed the clinical benefits of
external extended ECG monitoring, such as offering easy access to
patients by having inventory readily available at the point of care,
being able to return the device in a postage paid box thus preventing a
return trip to the hospital or doctor's office, and having the option
for a monitor that provides greater than 24-48 hours of data that
providers need access to for clinical decision making. Commenters
stated that the proposal of national pricing would help to provide
greater stability in payment for these services and ensure continued
access to care for beneficiaries.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters submitted additional invoices
associated with the pricing of the ``extended external ECG patch,
medical magnetic tape recorder'' (SD339) supply. Commenters stated that
they believe these additional invoices would help better capture the
market-based costs associated with the SD339 supply.
Response: We appreciate the submission of invoices with additional
pricing information from the commenters in helping to determine the
most accurate price for the SD339 supply. We averaged together the
price of the new invoices with the invoices that we had previously
received prior to the publication of the CY 2023 PFS proposed rule.
After averaging together these 21 invoices, we are finalizing an
updated price of $260.35 for the SD339 supply.
Comment: Several commenters stated that they supported the proposal
of national pricing and the proposed price of $245.69 for the SD339
supply; however they noted that the result does not adequately reflect
the cost of delivering these services by independent diagnostic testing
facilities (IDTFs). Commenters stated that KPMG, in conjunction with
AdvaMed, performed and presented a detailed cost analysis to CMS and
individual MACs requesting a reevaluation of the PE inputs. Commenters
stated that this analysis segregated costs into three categories: (1)
cost of goods sold including costs directly related to the devices,
supplies, production overhead and shipping; (2) direct labor, including
manufacturing a product or provision of a service and clinical
services; and (3) other indirect costs (IT support, finance, rent), and
stated that all three categories were necessary to fully account for
and understand the resources expended by an IDTF to provide LT-ECG
services. Commenters also stated that these three categories did not
consider the consumption of non-device assets used in the delivery of
LT-ECG (for example, software and processing) or the costs associated
with the purchase of capital equipment, regulatory, and research and
development expenses. This cost analysis summed to $300.68 for the
total cost of providing LT-ECG services, including capital expenditures
and research and development costs; a separate commenter submitted a
related cost analysis that summed to $283.89. Commenters requested that
the Extended External ECG Monitoring services be priced in accordance
with the updated costs from the AdvaMed/KPMG analysis as the CMS
proposed pricing does not adequately account for all the costs
associated with manufacturing and delivery of the associated monitoring
services (for example, software and processing) that are necessary for
efficient and effective delivery of services.
Response: We appreciate the presentation of these additional cost
analyses from the commenters for use in pricing the Extended External
ECG Monitoring codes. However, we did not propose to use these external
cost analyses in valuing these codes and they do not fit easily within
the framework of how our PE methodology operates. As the commenters
noted, these cost analyses include delivery, software, and processing
expenses which are typically considered to be forms of indirect PE
under our methodology. These indirect expenses would not be included in
the invoice pricing of the SD339 supply which we sought comment upon in
the proposed rule. The commenters also explicitly stated that their
cost analyses for providing Extended External ECG Monitoring services
included costs associated with research and development, which are not
costs that we include when determining the price of a service under our
PE methodology, as they are not connected to the furnishing of the
service itself.
More broadly, our PE allocation currently makes use of a ``bottom
up'' methodology that sums the typical and medically necessary
resources associated with each service and uses them to calculate the
PE RVU. The cost analyses submitted by the commenters are forms of a
``top down'' analysis which have not been used as the basis of our PE
methodology since we finalized the changes to the current system in CY
2007. (For a detailed explanation of the direct PE methodology,
including examples, we refer readers to the 5-year review of work RVUs
under the PFS and proposed changes to the PE methodology CY 2007 PFS
proposed notice (71 FR 37242) and the CY 2007 PFS final rule with
comment period (71 FR 69629).) This is not to say that the cost
analyses submitted by the commenters are irrelevant to the process of
valuing the Extended External ECG Monitoring services, as they can be a
useful tool in determining accurate market-based pricing. However, they
cannot be directly utilized to determine the most accurate price for
the SD339 supply, especially given that these cost analyses include
additional expenses such as delivery, processing, and research/
development costs which would not typically be considered direct
expenses under our PE methodology.
We also note that the AdvaMed/KPMG cost analysis submitted by the
commenters with a total cost of $300.68 for the Extended External ECG
Monitoring services includes research and development costs of $38.50
in its total expenses. As stated above, our PE methodology does not
recognize research and development costs when determining the prices of
services, only those resources individually allocable to the service
which are both typical and medically necessary. When these are removed,
the resulting total cost of $262.18 closely matches our proposed
pricing for the External ECG Monitoring services. We believe that these
cost analyses ultimately reinforce the accuracy of our proposals after
excluding the costs which would not be included under our PE
methodology.
Comment: A commenter had a series of questions regarding the
invoices used to establish the pricing for the SD339 supply. The
commenter outlined six different scenarios asking whether these
invoices constituted health insurance claims, entire technical services
billed by IDTFs, individual single-use patches, and several related
scenarios. The commenter requested additional information about the
invoices used for pricing the SD339 supply based on these different
scenarios.
Response: As detailed above, we received 21 invoices which we
averaged together under our typical pricing methodology which resulted
in a price of $260.35 for the SD339 supply. We reviewed each invoice
and determined that the price was associated with an individual
extended external ECG patch, not health insurance claims or entire
technical services. We did separately receive ``top down'' cost
analyses from several commenters, as discussed above, but these were
not invoices for the SD339 supply, and therefore, we did not include
them as part of the averaged invoice price.
Comment: A commenter asked CMS to explain why the CY 2023 proposed
[[Page 69516]]
rule used a new batch of invoices to price the SD339 supply which
superseded rather than added to the CY 2022 final rule's batch of
invoices for the same supply. The commenter stated that CMS did not
explain what about the new invoices was superior and more likely to be
representative and valid of national costs for the SD339 supply. The
commenter requested that CMS provides more detail about what the
invoice data they have received are, and why CMS has included or
excluded when specifying the input.
Response: When we use invoices to update supply and equipment
pricing, we find ourselves typically working with a small amount of
submitted invoice data. It is not uncommon to use a single invoice to
update supply and equipment pricing for lack of additional invoices
associated with the item in question. The limited amount of invoice
data sometimes results in making use of invoices across different
calendar years in order to get a more representative sample of market-
based pricing. However, our preference is always to use more recent
pricing information whenever possible since it will be more reflective
of current market-based pricing for the item in question.
In the case of the SD339 supply, we received a large quantity of
invoices (21 in total) from multiple different interested parties.
Because we had an abundance of invoice data associated with this
supply, we averaged together the invoices from the CY 2023 cycle and
did not need to include the older invoices from the CY 2022 cycle. We
did not include them for the simple reason that they constituted older
pricing which was less reflective of current market pricing. We
typically do not exclude any invoices in making supply and equipment
pricing determinations, however we do not believe that it would be
accurate to use older, outdated data when we have readily available
invoices which are more current.
Comment: A commenter stated that an underlying problem for
establishing appropriate payment rates for External Extended ECG
Monitoring is the IDTF model itself, which does not easily fit into the
CMS methodology for paying for physician services. The commenter stated
that the current PE methodology is based on outdated data from the 2006
PPI Survey performed by the American Medical Association and mostly
focuses on expenses related to the traditional physician office which
the commenter stated that they did not believe to be comprehensive or
accurate. The commenter urged CMS to develop a survey appropriate for
IDTFs, especially IDTFs that perform remote monitoring, which would
capture unique components of the IDTF cost structure such as expenses
related to research and development and unique challenges and
regulatory requirements related to AI and software as a service (SaaS).
Response: We agree with the commenter on the need for comprehensive
and accurate data for use in our PE methodology. We continue to be
interested in potential approaches that can be used to update aspects
of the PE methodology, which is why we solicited comments on Strategies
for Updates to Practice Expense Data Collection and Methodology in the
PE section of the rule. We direct readers to section II.B.5. of this
final rule for the full discussion of this topic along with additional
comments that we received.
After consideration of the comments, we are finalizing national
pricing for CPT codes 93241, 93243, 93245, and 93247 along with an
updated price of $260.35 for the SD339 supply.
(26) Cardiac Ablation (CPT Codes 93653, 93654, 93655, 93656, and 93657)
The technologies and clinical practices associated with Cardiac
Ablation Services have changed enough over the past decade (since 2011
when they were first developed) that the specialty societies
recommended referring theses codes to the CPT Editorial Panel to have
the code descriptors for Cardiac Ablation Services updated to create
new and more complete descriptors reflecting the fact that many of
these services are commonly performed together and should be
incorporated and bundled. From the survey results presented to CMS last
year, the RUC advisory committee believes that many of the survey
respondents may not have realized that the code descriptors had been
substantially revised and that they may not have read the updated code
descriptors thoroughly enough to understand that services that are
separately billed, were now combined into the existing codes (since CPT
did not issue new codes for the revised descriptors). Since then, the
RUC has re-surveyed these Cardiac Ablation codes in April 2021 for re-
review. In the interim, the work RVUs for the newly bundled CPT codes
were maintained at their current values until the new recommendations
were presented for CY 2023.
The RUC re-surveyed and reviewed CPT code 93653 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; treatment of
supraventricular tachycardia by ablation of fast or slow
atrioventricular pathway, accessory atrioventricular connection, cavo-
tricuspid isthmus or other single atrial focus or source of atrial re-
entry), and recommends a work RVU of 15.00 with 31 minutes of pre-
service evaluation time, 3 minutes positioning time, 15 minutes scrub/
dress/wait time, 120 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 199 minutes of total time.
CPT code 93653 currently has a work RVU value of 14.75 with 23 minutes
of pre-service evaluation time, 1 minutes positioning time, 5 minutes
scrub/dress/wait time, 180 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 239 minutes of total time.
The time and the physician's work of CPT add-on code 93613
(Intracardiac electrophysiologic 3-dimensional mapping (List separately
in addition to code for primary procedure) with a work RVU of 5.23 and
90 minutes of total time, and CPT add-on code 93621 (Comprehensive
electrophysiologic evaluation including insertion and repositioning of
multiple electrode catheters with induction or attempted induction of
arrhythmia; with left atrial pacing and recording from coronary sinus
or left atrium (List separately in addition to code for primary
procedure)) with a work RVU of 1.50 and 20 minutes of total time are
bundled within CPT code 93653. When all three codes are separately
considered, they currently sum up to 21.48 work RVUs, much greater than
the 15.00 work RVUs that the RUC has recommended. These codes also add
up to much more physician total time than the RUC-recommended 199
minutes.
After reviewing this code and relative similar codes in the PFS, we
proposed a comparator CPT code 37229 (Revascularization, endovascular,
open or percutaneous, tibial, peroneal artery, unilateral, initial
vessel; with atherectomy, includes angioplasty within the same vessel,
when performed) with a work RVU of 13.80 and a similar intra-service
time of 120 minutes and similar pre-service evaluation, pre-service
positioning, pre-service scrub/dress/wait times, and
[[Page 69517]]
immediate post-service times, for a sum of 188 minutes of total time
for a 000 day global period, compared to the RUC-recommended 199
minutes of total time for CPT code 93653. We proposed a work RVU of
13.80 for the bundled CPT code 93653.
The RUC re-surveyed and reviewed CPT code 93654 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; with treatment of
ventricular tachycardia or focus of ventricular ectopy including left
ventricular pacing and recording, when performed), and recommends a
work RVU of 18.10 with 40 minutes of pre-service evaluation time, 3
minutes positioning time, 15 minutes scrub/dress/wait time, 200 minutes
of intra-service time, 33 minutes of immediate post-service time, for a
sum of 291 minutes of total time. CPT code 93654 currently has a work
RVU value of 19.75 with 23 minutes of pre-service evaluation time, 1
minutes positioning time, 5 minutes scrub/dress/wait time, 240 minutes
of intra-service time, 40 minutes of immediate post-service time, for a
sum of 309 minutes of total time. CPT code 93654 is currently and
continues to be a bundled code. The RUC recommended intra-service times
and total times for CPT code 93654 are less than the current times for
this code, and the RUC-recommended work RVUs are also less than the
current work RVUs. Though the RUC recommended a work RVU of 18.10, it
is still a relatively high value compared to the existing 19.75 value.
The RUC recommended a work RVU of 15.00 for CPT code 93653, and 18.10
for CPT code 93654, with a relative increment between them of 3.10 work
RVUs. We proposed to maintain the relative increment RVU difference of
3.10 between CPT code 93653 and CPT code 93654, so because we proposed
a work RVU of 13.80 for CPT code 93653, we proposed a work RVU of 16.90
(13.80 plus 3.10) for CPT code 93654, with 200 minutes of intra-service
time and 291 minutes of total time.
CPT add-on code 93655 (Intracardiac catheter ablation of a discrete
mechanism of arrhythmia which is distinct from the primary ablated
mechanism, including repeat diagnostic maneuvers, to treat a
spontaneous or induced arrhythmia (List separately in addition to code
for primary procedure)) has a current work RVU of 5.50 with a physician
intra-service time of 60 minutes as finalized last year, from a
previous value of 7.50 work RVUs with 90 minutes of physician intra-
service time. The RUC recommended the re-surveyed intraservice time of
60 minutes and 7.00 work RVUs. The primary change to CPT code 93655 is
the reduction of the intraservice time of about 67 percent, which we
use as a guide to determine a work RVU. We compared CPT add-on code
22854 (Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to vertebral
corpectomy(ies) (vertebral body resection, partial or complete) defect,
in conjunction with interbody arthrodesis, each contiguous defect (List
separately in addition to code for primary procedure)), also with 60
minutes of intraservice and total time and a work RVU of 5.50 to CPT
add-on code 93655 and we believed that it is a more accurate valuation
than the RUC's work RVU comparison to CPT add-on code 93592
(Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)) with a work RVU of 8.00 and an intra-service and
total time of 60 minutes, and to CPT add-on code 34820 (Open iliac
artery exposure for delivery of endovascular prosthesis or iliac
occlusion during endovascular therapy, by abdominal or retroperitoneal
incision, unilateral (List separately in addition to code for primary
procedure)) with a work RVU of 7.00 and an intra-service and total time
of 60 minutes. After reviewing this code and relative similar codes in
the PFS, we proposed to maintain the current work RVU for CPT code
93655 of 5.50 with a physician intra-service time of 60 minutes, as
finalized last year (86 FR 65108).
The RUC re-surveyed and reviewed CPT code 93656 (Comprehensive
electrophysiologic evaluation including transseptal catheterizations,
insertion and repositioning of multiple electrode catheters with
intracardiac catheter ablation of atrial fibrillation by pulmonary vein
isolation, including intracardiac electrophysiologic 3-dimensional
mapping, intracardiac echocardiography including imaging supervision
and interpretation, induction or attempted induction of an arrhythmia
including left or right atrial pacing/recording, right ventricular
pacing/recording, and His bundle recording, when performed), and
recommends a work RVU of 17.00 with 35 minutes of pre-service
evaluation time, 3 minutes positioning time, 15 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 30 minutes of immediate
post-service time, for a sum of 263 minutes of total time. CPT code
93656 currently has a work RVU of 19.77 with 23 minutes of pre-service
evaluation time, 1 minute positioning time, 5 minutes scrub/dress/wait
time, 240 minutes of intra-service time, 40 minutes of immediate post-
service time, for a sum of 309 minutes of total time. CPT code 93656
has bundled within it, the time and the physician's work of CPT add-on
code 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List
separately in addition to code for primary procedure) with a work RVU
of 5.23 and 90 minutes of total time and CPT add-on code 93662
(Intracardiac echocardiography during therapeutic/diagnostic
intervention, including imaging supervision and interpretation (List
separately in addition to code for primary procedure)) with a work RVU
of 1.44 and 25 minutes of total time. When all three codes are
separately considered, they sum up to 26.44 work RVUs, which is much
greater than the 17.00 work RVUs that is recommended and has much more
physician total time than the RUC recommended 263 total time minutes.
The RUC recommended intra-service times and total times for CPT
code 93656 that are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs. Though
the RUC recommended a work RVU of 17.00, it is still a high value
compared to the existing 19.77. The RUC recommended the work RVU for
CPT code 93653 as 15.00, and for CPT code 93656 as 17.00, with a
relative increment between them of 2.00 work RVUs. As a better
valuation for CPT code 93656, we proposed a work RVU of 13.80 for CPT
code 93653 plus the relative increment RVU difference of 2.00 that the
RUC is maintaining between CPT code 93653 and CPT code 93656 (15.00
subtracted from 17.00 equals 2.00). This would value CPT code 93656 at
15.80 (13.80 plus 2.00) work RVUs for 180 minutes of intra-service time
and 263 minutes of total time, which we propose for CY 2023.
CPT add-on code 93657 (Additional linear or focal intracardiac
catheter ablation of the left or right atrium for treatment of atrial
fibrillation remaining after completion of pulmonary vein isolation
(List separately in addition to
[[Page 69518]]
code for primary procedure)) has a current work RVU of 5.50 with a
physician intra-service time of 60 minutes as finalized last year (86
FR 65108). The previous work RVU was 7.50 with 90 minutes of physician
intraservice time. The RUC recommended the re-surveyed intra-service
time of 60 minutes and 7.00 work RVUs. The primary change to CPT add-on
code 93657 is the reduction of the intra-service time from before the
re-survey and the current RUC-recommended time, from 90 minutes to 60
minutes, which is a reduction of about 67 percent, and which we used as
a guide to determine an appropriate work RVU. We compare CPT add-on
code 22854 (Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to vertebral
corpectomy(ies) (vertebral body resection, partial or complete) defect,
in conjunction with interbody arthrodesis, each contiguous defect (List
separately in addition to code for primary procedure)), also with 60
minutes of intra-service and total time, and a work RVU of 5.50, to CPT
add-on code 93657, and believe that this is a more accurate comparison
for valuation than the RUC's work RVU comparison to CPT add-on code
93592 (Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)) with a work RVU of 8.00 and an intra-service and
total time of 60 minutes, and to CPT add-on code 34820 (Open iliac
artery exposure for delivery of endovascular prosthesis or iliac
occlusion during endovascular therapy, by abdominal or retroperitoneal
incision, unilateral (List separately in addition to code for primary
procedure)) with a work RVU of 7.00 and an intra-service and total time
of 60 minutes. After reviewing this code and relative similar codes in
the PFS, we proposed to re-affirm the current work RVU of 5.50 with a
physician intraservice time of 60 minutes for CPT add-on code 93657, as
finalized last year (86 FR 65108).
The RUC did not recommend, and we did not propose, direct PE inputs
for CPT codes 93653-93657.
We received many comments concerning CMS' proposed work RVUs for
these Cardiac Ablation CPT codes 93653, 93654, 93655, 93656, and 93657.
Comment: Commenters were uniformly against the CMS proposed work
RVUs for these codes and urged CMS to accept the AMA RUC-recommended
values supported by a robust survey. Commenters argued that the CMS
proposed work RVUs for these services are inappropriately low for the
long lengths of time required to perform these services, and also
neglect to account for the higher intensity of the physician's work
with a live beating heart.
Response: Since CY 2011, when these codes were first developed and
valued, there is no doubt that cardiac ablation technologies and
clinical practices have changed and matured, and thus, these codes were
brought to our attention by the AMA RUC for an overdue review. Over the
last decade, there have been improvements in the related technologies,
new informative results from ongoing research in cardiac ablation, and
physicians who have improved their skills and experience and training,
all contributing to better methodologies that are refined, to an
improved new standard for cardia ablation. They are now performing
these services faster, more efficiently, more safely, and more
effectively, with better outcomes. This also includes the elimination
of duplications of effort, procedure overlaps, and ineffective past
practices. Of course, on the other hand, some new techniques and
methodologies may require performing concurrent procedures making the
better service more complex and more demanding. With all this said, we
do agree that cardiac ablation is a complicated and comparatively
intensive set of procedures that does take a good amount of time to
complete, and that the subsequent changes over the last 10 years have
recognized the need to now bundle these services to reflect current
typical practices.
At present, the cardiac ablation base CPT codes and their
accompanying CPT codes that are paying separately, sum to a total work
RVU of 21.48. CPT code 93653 paying 14.75 work RVUs; with CPT code
93613 paying 5.23 work RVUs; and CPT code 93621 paying 1.50 work RVUs.
Since the AMA CPT Panel and the RUC are recommending the bundling of
these three service codes into CPT code 93653, their recommended work
RVUs for CPT code 93653 is 15.00, and is 69.8 percent of the original
summed value of 21.48. We further refined the newly bundled work to
13.80 work RVUs and that is 64.2 percent of the original summed value,
reflecting what we perceived as improvements and efficiencies gained in
how these procedures are now furnished.
Comment: Commenters disagreed with the CMS proposed work RVUs for
the cardiac ablation add-on codes and urged CMS to accept the AMA RUC-
recommended values.
Response: We remind commenters that those work RVU values were
accepted and finalized in last year's rule (86 FR 65108). We accepted
the RUC-recommended reductions in physician time from 90 minutes to 60
minutes of intra-service and total time, with a final work RVU of 5.50
for CPT code 93655. We accepted the RUC-recommended reductions in
physician time from 90 minutes to 60 minutes of intra-service and total
time, with a final work RVU of 5.50 for CPT code 93657, and we see no
reason change those final values.
We note that it is challenging to make definitive conclusions about
comparisons of relative intensity of work for the same unit of time,
especially without seeing objective or competing viewpoints for some or
most of the procedures that currently have similar valuations. In
developing the PFS, CMS works to mitigate any perceived or explicit
bias against or for any organ system or type of services, which may
distort actual importance to beneficiaries' health and safety. We also
note that levels of intensity can be mathematically different with the
shifting of pre-service minutes or immediate post service minutes, to
or from intra-service minutes, where intensity values are derived.
After review and consideration of all comments on our proposals for
CPT codes 93653, 93654, and 93656, we are persuaded by these comments,
and we are finalizing RUC-recommended values of 15.00, 18.10, and
17.00, respectively. CPT add-on codes 93655 and 93657 both remain
finalized at 5.50 work RVUs from last year.
(27) Pulmonary Angiography (CPT Codes 93569, 93573, 93574, 93575,
93563, 93564, 93565, 93566, 93567, and 93568)
In May 2021, the CPT Editorial Panel revised CPT code 93568
(Injection procedure during cardiac catheterization including imaging
supervision, interpretation, and report; for nonselective pulmonary
arterial angiography (List separately in addition to code for primary
procedure) which resulted in the creation of four new related CPT add-
on codes. CPT add-on codes 93563 to 93567 were surveyed with the four
new codes, as part of the same code family.
The RUC surveyed and reviewed CPT code 93563 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective coronary angiography during
congenital heart catheterization (List separately in
[[Page 69519]]
addition to code for primary procedure)), and recommends a work RVU of
1.11 for 15 minutes of intra-service and total time for this add-on
service. The current work RVU is 1.11 for 25 minutes of intra-service
and total time, so there is a reduction of 10 minutes in physician
time. With the reduction of physician time, it is typical that there
would be some reduction in the work RVUs. After reviewing this code and
relative similar codes in the PFS, we believe a better comparator add-
on code would be CPT code 64494 (Injection(s), diagnostic or
therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves
innervating that joint) with image guidance (fluoroscopy or CT), lumbar
or sacral; second level (List separately in addition to code for
primary procedure)), with a work RVU of 1.00 for 15 minutes of intra-
service and total time. CPT code 64494 is a good comparator in terms of
both the new physician time and due to the proportional work RVU, as
compared to CPT code 93563. Therefore, we proposed a work RVU of 1.00
and 15 minutes of intra-service and total time for add-on CPT code
93563.
The RUC surveyed and reviewed CPT code 93564 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective opacification of
aortocoronary venous or arterial bypass graft(s) (e.g., aortocoronary
saphenous vein, free radial artery, or free mammary artery graft) to
one or more coronary arteries and in situ arterial conduits (e.g.,
internal mammary), whether native or used for bypass to one or more
coronary arteries during congenital heart catheterization (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 1.13 for 18 minutes of intra-service and total time for
this add-on service. The current work RVU is 1.13 for 25 minutes of
intra-service and total time, so there is a reduction of 7 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 31632 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
transbronchial lung biopsy(s), each additional lobe (List separately in
addition to code for primary procedure)) with a work RVU of 1.03 for 18
minutes of intra-service and total time. CPT code 31632 is a good
comparator in terms of both the new physician time and due to the
proportional work RVU, as compared to CPT code 93564. Therefore, we
proposed a work RVU of 1.03 and 18 minutes of intra-service and total
time for add-on CPT code 93564.
The RUC surveyed and reviewed CPT code 93565 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective left ventricular or left
atrial angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU as compared
to CPT code 93565. Therefore, we proposed a work RVU of 0.50 and 10
minutes of intra-service and total time for add-on CPT code 93565.
The RUC surveyed and reviewed CPT code 93566 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective right ventricular or right
atrial angiography (List separately in addition to code for primary
procedure)) and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU, as
compared to CPT code 93566. Therefore, we proposed a work RVU of 0.50
and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93567 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for supravalvular aortography (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 0.97 for 10 minutes of intra-service and total time for
this add-on service. The current work RVU is 0.97 for 15 minutes of
intra-service and total time, so there is a reduction of 5 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 74248 (Radiologic small
intestine follow-through study, including multiple serial images (List
separately in addition to code for primary procedure for upper GI
radiologic examination)) with a work RVU of 0.70 for 10 minutes of
intra-service and total time. CPT code 74248 is a good comparator code
in terms of both the new physician time and due to the proportional
work RVU, as compared to CPT code 93567. Therefore, we proposed a work
RVU of 0.70 and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93568 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for nonselective pulmonary arterial
angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.88 for 13 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.88 for 20 minutes of intra-service and total time, so there is a
reduction of 7 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we agree with the RUC recommendation and proposed a work RVU of
0.88 with 13 minutes of intra-service and total time for add-on CPT
code 93568.
For the first of the related four new add-on codes to this family,
CPT code 93569 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary arterial angiography, unilateral (List separately
in addition to code for primary procedure)), the RUC recommended a work
RVU of 1.05 for 11 minutes of
[[Page 69520]]
intra-service and total time for this add-on service. The RUC noted
that the typical patient for this service is pediatric. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 78434 (Absolute quantitation
of myocardial blood flow (AQMBF), positron emission tomography (PET),
rest and pharmacologic stress (List separately in addition to code for
primary procedure)) with a work RVU of 0.63 for 11 minutes of intra-
service and total time. CPT code 78434 is a good comparator code in
terms of both the physician time, and due to the proportional work RVU,
as compared to CPT code 93569. Therefore, we proposed a work RVU of
0.63 and 11 minutes of intra-service and total time for add-on CPT code
93569.
For the second of the related four new add-on codes to this family,
CPT code 93573 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary arterial angiography, bilateral (List separately in
addition to code for primary procedure)), the RUC recommended a work
RVU of 1.75 for 18 minutes of intra-service and total time for this
add-on service. The RUC noted that the typical patient for this service
is pediatric and that this service is bilateral. After reviewing this
code and relative similar codes in the PFS, we believe a better
comparator add-on code would be HCPCS code G0289 (Arthroscopy, knee,
surgical, for removal of loose body, foreign body, debridement/shaving
of articular cartilage (chondroplasty) at the time of other surgical
knee arthroscopy in a different compartment of the same knee (List
separately in addition to code for primary procedure)) with a work RVU
of 1.48 for 20.5 minutes of intra-service and total time and that this
service is bilateral. G0289 has 2.5 minutes of additional physician
intra-service time, so we adjusted the comparator work RVU from 1.48 to
1.30. Therefore, we proposed 1.30 work RVUs for 18 minutes of intra-
service and total time for add-on CPT code 93573.
For the third of the related four new add-on codes to this family,
CPT code 93574 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary venous angiography of each distinct pulmonary vein
during cardiac catheterization. (List separately in addition to code
for primary procedure)), the RUC recommended a work RVU of 1.84 for 20
minutes of intra-service and total time for this add-on service. The
RUC noted that the typical patient for this service is pediatric. After
reviewing this code and relative similar codes in the PFS, we believe a
better comparator add-on code would be CPT code 93598 (Measurement of
output of blood from heart, performed during cardiac catheterization
for evaluation of congenital heart defects (List separately in addition
to code for primary procedure)) with a work RVU of 1.44 for 20 minutes
of intra-service and total time. CPT code 93598 is a good comparator
code in terms of both the physician time, and due to the proportional
work RVU, as compared to CPT code 93574. Therefore, we proposed 1.44
work RVUs for 20 minutes of intra-service and total time for add-on CPT
code 93574.
For the last of the related four new add-on codes to this family,
CPT code 93575 (Injection procedure during cardiac catheterization
including imaging supervision, interpretation, and report; for
selective pulmonary angiography of major aortopulmonary collateral
arteries (MAPCAs) arising off the aorta or its systemic branches, each
distinct vessel)), the RUC recommended a work RVU of 1.92 for 20
minutes of intra-service and total time for this add-on service. The
RUC describes this service and the physician's work as very time-
intensive and complicated, and the typical patient for this service is
pediatric. We agree with the RUC recommendations and proposed a work
RVU of 1.92 with 20 minutes of intra-service and total time for add-on
CPT code 93575.
The RUC did not recommend, and we did not propose, direct PE inputs
for CPT codes 93563-93575.
Numerous comments were submitted concerning this family of
pulmonary angiography codes all against the CMS-proposed RVU values.
Comment: Commenters noted that CMS is equating reductions in
physician times with reductions in work RVUs, with this family of
codes, without regard to the intensity or complexity of these pulmonary
procedures, or that some of these codes are primarily typical with
pediatrics and congenital heart disease. Commenters recommended that
CMS reconsider their proposed values as being too low and to accept the
AMA RUC recommended values.
Response: As commenters know, we are obligated to take into account
changes in physician times and intensity with changes in work RVUs. We
appreciate all of the time and efforts commenters place into their
extensive comments in responding to our proposals and we do review
these comments in detail to improve our proposals where warranted. When
we observe reductions in physician times and no significant change to
the procedure's description of work and no change in the procedure's
work RVU, or we see recommendations of increases in the procedure's
work RVU, we wonder how the intensity of the procedure has changed.
Improvements in these procedure's technologies and physicians' training
in new skills and methods do contribute to faster, and more efficient
outcomes and would result in the reduction of a procedure's work time.
At the same time, where duplicate and overlapping efforts are
eliminated, new techniques can also introduce complexities that would
contribute to the work's intensity without the addition of work time.
However, these add-on codes reduce physician work times, and the nature
of the PFS relative value system is such that all services are subject
to comparisons to one another.
However, we do agree with the commenters' point regarding CPT code
93569 and our proposed work RVU value of 0.63. Our proposed work RVU
creates a rank order anomaly within this family of codes whose patients
are pediatrics. The AMA RUC-recommended work RVUs between CPT code
93569 and CPT code 93573 reflect about a 67 percent difference between
the two codes. Our proposed work RVU for CPT code 93569 of 0.63 is
about a 106 percent higher than our proposed work RVU of 1.30 for CPT
code 93573, which created a large difference. To correct this error and
to maintain that RUC-recommended interval difference between these two
codes, we are finalizing a corrected work RVU of 0.78 for CPT code
93569, by applying that RUC-recommended interval difference between CPT
codes 93569 and 93573 (1.30 divided by 1.67 = 0.78). This aligns with
the intra-service minutes difference between CPT codes 93569 (11
minutes) and 93573 (18 minutes) and the comparator CPT code 58110
(Endometrial sampling (biopsy) performed in conjunction with colposcopy
(List separately in addition to code for primary procedure)), with
similar physician intra-service minutes and a similar work RVU of 0.77.
After review and consideration of all comments on our proposals for
these Pulmonary Angiography codes, we are finalizing all work RVUs as
proposed except for CPT code 93569, whose work RVU we are adjusting
from 0.63 to 0.78 for CY 2023.
[[Page 69521]]
(28) Quantitative Pupillometry Services (CPT Code 95919)
The CPT Editorial Panel approved a new Category I CPT code to
replace the sunset Category III (CPT code 0341T Quantitative
pupillometry with interpretation and report, unilateral or bilateral)
and 92499 (Unlisted ophthalmological service or procedure for reporting
this service).
We did not propose the RUC-recommended work RVU of 0.25 for CPT
code 95919, as we believe this is an overestimation based on a
comparison to other codes with similar time values, particularly the
key reference code CPT code 92081 (Visual field examination, unilateral
or bilateral, with interpretation and report; limited examination
(e.g., tangent screen, Autoplot, arc perimeter, or single stimulus
level automated test, such as Octopus 3 or 7 equivalent). In the
interest of maintaining relativity with similarly timed codes, we are
instead proposing a work RVU of 0.18 with a crosswalk to CPT code 92504
(Binocular microscopy (separate diagnostic procedure)). We noted that
this value falls between the work RVUs of 0.17 for CPT code 94010
(Spirometry, including graphic record, total and timed vital capacity,
expiratory flow rate measurement(s), with or without maximal voluntary
ventilation) and 0.20 for CPT code 77081 (Dual-energy X-ray
absorptiometry (DXA), bone density study, 1 or more sites; appendicular
skeleton (peripheral) (e.g., radius, wrist, heel)); both codes have
identical intraservice times and similar total times.
We proposed the RUC-recommended direct PE inputs without
refinement.
Comment: Commenters did not support our proposed work RVU of 0.18
rather than the RUC-recommended 0.25. A commenter asserted that the RUC
survey results are robust and that CMS did not furnish evidence that
this service is appropriately valued below the 25th survey percentile.
Another commenter stated that CPT code 92504 is a less appropriate
crosswalk than the RUC's crosswalk of CPT code 72190 as it does not
match the pre/intra/post times and because it was last revalued in
2010.
Response: The RUC-recommended RVU of 0.25 was high in comparison to
the range of RVUs for the comparison CPT codes with the same intra-
service time and similar total times, and therefore, we believe that
CPT code 92504 is a valid crosswalk. We continue to believe that,
particularly given that this service is likely to be performed multiple
times in a single day, the RUC-recommended value represents a slight
overestimation of intensity. We acknowledge that the work times were
not an exact match with CPT code 92504 but closely matched the
intraservice and total times, and we continue to believe that this is
an appropriate crosswalk.
We are finalizing as proposed a work RVU of 0.18 for CPT code 95919
and the RUC-recommended direct PE inputs without refinement.
(29) Caregiver Behavior Management Training (CPT Codes 96202 and 96203)
CPT code 96202 (Multiple-family group behavior management/
modification training for guardians/caregivers of patients with a
mental or physical health diagnosis, administered by physician or other
qualified health care professional (without the patient present), face-
to-face with multiple sets of guardians/caregivers; initial 60 minutes)
and its add-on code, CPT code 96203 (Multiple-family group behavior
management/modification training for guardians/caregivers of patients
with a mental or physical health diagnosis, administered by physician
or other qualified health care professional (without the patient
present), face-to-face with multiple sets of guardians/caregivers; each
additional 15 minutes (List separately in addition to code for primary
service)), are new codes created by the CPT Editorial Panel during its
February 2021 meeting. The two codes are to be used to report the total
duration of face-to-face time spent by the physician or other qualified
health professional providing group training to guardians or caregivers
of patients. Although the patient does not attend the group trainings,
the goals and outcomes of the sessions focus on interventions aimed at
improving the patient's daily life. According to the CPT Summary of
Recommendations, during the face-to-face service time, caregivers are
taught how to structure the patient's environment to support and
reinforce desired patient behaviors, to reduce the negative impacts of
the patient's diagnosis on the patient's daily life, and to develop
highly structured technical skills to manage patient behavior. As a
means of identifying work values for CPT codes 96202 and 96203, three
specialty societies sent surveys to a random sample of a subset of
their members. Based upon survey results and after discussion, the RUC
recommended a work RVU of 0.43 per identified patient service for CPT
code 96202. The RUC noted that this recommendation is based upon a
median group size of six caregivers and includes 10 minutes pre-time,
60 minutes intra-time, and 20 minutes post-time for a total time of 90
minutes. For CPT code 96203, the 15-minute add-on code, the RUC
recommended a work RVU of 0.12, which is also based upon a median group
size of six. After reviewing the caregiver training codes, we stated in
the proposed rule that CPT codes 96202 and 96203 are not payable under
the PFS. We noted that in past rulemaking, we have explained that we
read section 1862(a)(1)(A) of the Act to limit Medicare coverage and
payment to items and services that are reasonable and necessary for the
diagnosis and treatment of an individual Medicare beneficiary's illness
or injury or that improve the functioning of an individual Medicare
beneficiary's malformed body member. For example, in the CY 2013 PFS
final rule (77 FR 68979), when discussing payment for the non-face-to-
face care management services that are part of E/M services, we stated
that Medicare does not pay for services that are furnished to parties
other than the beneficiary. We listed as an example, communication with
caregivers. Because the codes for caregiver behavior management
training describe services furnished exclusively to caregivers rather
than to the individual Medicare beneficiary, we did not review the RUC-
recommended valuation of these codes or propose to establish RVUs for
these codes for purposes of PFS payment. However, recognizing our focus
on ensuring equitable access to reasonable and necessary medical
services, we requested public comment about the services described by
these two codes. First, we sought comment on the ways in which a
patient may benefit when a caregiver learns strategies to modify the
patient's behavior. We also sought comment on how current Medicare
policies regarding these caregiver training services may impact
Medicare beneficiary health. Finally, we sought comment about how the
services described by these codes might be bundled into Medicare
covered services as incident to services or as practitioner work that
is part of some care management codes.
Below is a summary of the comments received.
Comment: Most commenters recommended that CMS pay for caregiver
behavioral management training services and to use the RUC-recommended
values for purposes of payment. Several appreciated CMS displaying the
RUC-recommended values. Several commenters asked CMS to reconsider its
position on the caregiver behavior management training codes, noting
that there is extensive
[[Page 69522]]
empirical support for caregiver behavior management training, and that
these services are a component of the standard of care for treatment of
several health behavior issues. Many commenters asserted that although
the patient is not present when this training is provided, these codes
have many specific, direct benefits for the patient. The RUC commented
that these codes allow for reporting the physician/QHP work and/or time
associated with the evidence-based behavioral management/modification
training of parent/caregivers, which is performed in tandem with the
diagnostic and intervention services furnished directly to the
``identified patient'' that support the patient's optimal level of
function.
Some commenters asserted that CMS' proposed application of section
1862(a)(1)(A) of the Act was not appropriate given the well-established
evidence of the direct effect the provision of these services on the
health outcomes associated with specific chronic conditions, including
a reduction in disruptive and problematic behaviors for children with
ADHD, improved weight management for individuals with obesity, and
better management of patients with dementia.
One commenter noted that if the patient's presence is a requirement
for these services, it becomes a barrier to this care for patients with
particular health conditions. One commenter indicated that these
services are specifically intended to prepare caregivers to implement
necessary elements of care plans. This commenter also suggested that
not paying for these services would contribute to health inequities
issue because in many cases the patients at issue have dementia and
other disorders that place them at great social and economic
disadvantage.
Commenters also noted that there are other CPT codes, several paid
separately under the PFS, that describe services that do not include
direct contact with the patient but are still considered integral to
the patient's care, including care management services and
interprofessional consultations.
Commenters also expressed broad support for the role of caregivers
in the health of individuals, indicating that the caregiver's play a
critical role in supporting patient care and that caregiver engagement
is an important part of the individual patient's plan of care. Other
commenters noted that these services when delivered in groups without
the patient present have clear advantages over services delivered
individually. The commenters suggested that caregiver engagement will
help reduce costs and improve access to care. Other commenters stated
these services enable caregivers to better address the patient's needs
and provide assistance to perform activities of daily living and family
caregivers who play a huge role in the patient's long-term care; and
many family caregivers are supporting patients with complex care, and
expressed fear of making a mistake, with concern being the greatest for
managing medications, using meters and monitors, and performing wound
care. Several commenters noted that caregiver behavior training is
evidence-based and providing training will promote improved outcomes.
A few commenters suggested that CMS might consider adding a
caregiver training element to the appropriate chronic care management
code and would be pleased to explore with CMS how to implement this
service.
Response: We appreciate the response from commenters. We
acknowledge the important role that caregivers can have in overall
care, especially for Medicare beneficiaries. We also acknowledge the
idea that broadly increasing the resources provided to caregivers could
have beneficial results on general well-being in addition to reductions
in the need for medical or institutional interventions.
However, under section 1862(a)(1)(A) of the Act, Medicare payment
is generally limited to those items and services that are reasonable
and necessary for the diagnosis or treatment of illness or injury or
that improve the functioning of a malformed body member. We sought
feedback on the ways in which a patient may benefit when a caregiver
learns strategies to modify the patient's behavior. We also sought
comment regarding how Medicare policies regarding these caregiver
training services may impact Medicare beneficiary health.
Commenters responded by explaining how the training services
provided directly to the caregiver treat beneficiary's health
conditions. Commenters also explained how the lack of access to these
standard treatments would have a disproportionately negative effect on
beneficiaries with particular conditions and the practitioners who
treat them. Commenters have highlighted that behavioral management/
modification training of parents/caregivers, when furnished in tandem
with other diagnostic and intervention services related to specific
treatment, can be integral to the treatment of a beneficiary's specific
condition. Commenters have also pointed out that to the extent that
this service is integral to evolving standards of care for people with
certain conditions, lack of payment for this service under the PFS
would likely result in an inappropriate payment disparity that would
have a detrimental impact on access to care for particular
beneficiaries and the physicians and other qualified health care
professionals that treat them.
We note that in the proposed rule we reiterated that Medicare does
not pay for services that are furnished to parties other than the
beneficiary. Over the past decade or more, in specific circumstances,
we have made payment for some care furnished to beneficiaries through
direct involvement of parents, guardians, or caregivers, as well as
through interactions with other medical professionals or clinical staff
rather than the beneficiary in-person. These circumstances include when
the lack of coding and payment for services historically not paid for
separately give rise to inappropriate payment disparities that do not
reflect the relative resources involved in furnishing treatment, given
the changes in medical practice that have led to more care
coordination/team-based care, and the idea that the resources involved
in those aspects of care are not adequately reflected in current
coding/payment. In these cases, we have created coding and separate
payment for services such as transitional care management (77 FR
68978), chronic care management (79 FR 67715), behavioral health
integration services (81 FR 80226), and virtual check-in services (83
FR 59483). In some cases, we have also specifically made payment for
services provided directly to caregivers when, in current practice and
in specific circumstances, they are an integral part of ongoing
treatment for some patients (81 FR 80331). In the CY 2017 PFS final
rule, we noted that we believe that CPT codes 96160 and 96161, Patient,
Caregiver-focused Health Risk Assessment codes, describe services that,
in particular cases, can be necessary components of services furnished
to Medicare beneficiaries. We recognized that in current medical
practice, practitioner interaction with caregivers is an integral part
of treatment for some patients. Accordingly, the descriptions for
several payable codes under the PFS include direct interactions between
practitioners and caregivers. We agreed with commenters, that there are
circumstances where this service is an essential part of a service to a
Medicare beneficiary. Therefore, we assigned active payment status to
both codes for CY 2017.
Based on public comments, we believe there could be circumstances,
captured in the medical record, where
[[Page 69523]]
separate payment for these services may be appropriate. We will
continue to consider and contemplate which circumstances or services
and for which beneficiaries it would be appropriate to furnish and
receive payment for these types of services in future notice and
comment rulemaking.
We appreciate the thoughtful feedback submitted by the public on
this matter. We intend to address these codes more thoroughly during
the CY 2024 rulemaking process as we review other coding and valuation
changes.
(30) Cognitive Behavioral Therapy Monitoring (CPT code 98978).
See the Remote Therapeutic Monitoring (RTM) section II.I. of this
final rule for a review of new device code, CPT code 98978.
(31) Code Descriptor Changes for Annual Alcohol Misuse and Annual
Depression Screenings (HCPCS Codes G0442 and G0444)
Interested parties have raised concerns with the portion of the
code descriptors that require a certain number of minutes to bill for
the HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and
G0444 (Annual depression screening, 15 minutes). Over the past several
years, AAFP and the ACP have requested that CMS revise the code
descriptors to state ``up to 15 minutes'' instead of the current ``15
minutes,'' allowing practitioners to efficiently furnish the service.
As currently described, claims for the service are said to be denied by
MACs in instances where records suggest that a full 15 minutes was not
reached by the practitioner when furnishing the service. Both codes
were high in volume for 2019 and 2020, with over 700,000 reported
services in our Medicare claims data.
Medicare Part B coverage for such screenings originated from a
national coverage determination (NCD) from 2011 and 2012. We believe
that these screenings may not require a full 15 minutes to perform for
the typical patient, so we believed that it would be appropriate to
propose to revise the descriptors to specify that screening times of 5
to 15 minutes would be the typical range to furnish these services.
This will establish a lower time limit for both HCPCS codes G0442 and
G0444. Therefore, we proposed to modify the descriptor for HCPCS code
G0442 to read ``Annual alcohol misuse screening, 5 to 15 minutes'' and
for HCPCS code G0444 to read ``Annual depression screening, 5 to 15
minutes.''
We received a number of comments concerning the adjustments to the
descriptors of HCPCS codes G0442 and G0444.
Comment: Commenters were all in favor of the descriptor changes
made for these codes and for the clarification of these services. The
commenters universally expressed their support and a few recommended
that CMS should re-review the valuations for these services to ensure
proper payment.
Response: We thank commenters for their supporting comments on the
descriptor adjustments to HCPCS codes G0442 and G0444. When substantial
descriptor changes are made to some CPT codes, that does signal to CMS
to re-review all aspects of a service and to possibly align for proper
payment. These descriptor changes were to HCPCS codes and they do not
change the currently established payments for them. They are just a
clarification for the claims process to smooth out any possible
misunderstanding of conditions of payment and our original intent in
allowing payments for these services.
After review and consideration of all comments regarding our
proposals for HCPCS codes G0442 and G0444, we are finalizing our
descriptor changes as proposed, to ``Annual alcohol misuse screening, 5
to 15 minutes'' for HCPCS code G0442 and to ``Annual depression
screening, 5 to 15 minutes.'' for HCPCS code G0444.
(32) Insertion, and Removal and Insertion of New 180-Day Implantable
Interstitial Glucose Sensor System (HCPCS Codes G0308 and G0309)
For the CY 2021 PFS final rule (85 FR 84645), we established
national pricing for 3 Category III CPT codes that describe continuous
glucose monitoring. Category III CPT codes 0446T (Creation of
subcutaneous pocket with insertion of implantable interstitial glucose
sensor, including system activation and patient training), 0447T
(removal of implantable interstitial glucose sensor from subcutaneous
pocket via incision), and 0448T (removal of implantable interstitial
glucose sensor with creation of subcutaneous pocket at different
anatomic site and insertion of new implantable sensor, including system
activation) describe the services related to the insertion, removal,
and removal and insertion of an implantable interstitial glucose sensor
from a subcutaneous pocket. The implantable interstitial glucose
sensors are part of systems that can allow real-time glucose
monitoring, provide glucose trend information, and signal alerts for
detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia). The direct PE
inputs for CPT code 0446T include a 90-day supply item, SD334
(implantable interstitial glucose sensor), and a 90-day smart
transmitter proxy equipment item, EQ392 (heart failure patient
physiologic monitoring equipment package). The direct PE inputs for CPT
code 0448T include only the 90-day SD334 interstitial glucose sensor.
For CY 2022, based on requests from interested parties for CMS to
allow beneficiaries critical access to a newly approved 180-day
continuous glucose monitoring system, CMS established two new HCPCS
codes to describe the new 180-day monitoring service. Specifically, CMS
established HCPCS code G0308 (Creation of subcutaneous pocket with
insertion of 180-day implantable interstitial glucose sensor, including
system activation and patient training) and G0309 (removal of
implantable interstitial glucose sensor with creation of subcutaneous
pocket at different anatomic site and insertion of new 180-day
implantable sensor, including system activation). The newly approved
180-day continuous glucose monitoring system extends the monitoring
period from the previous 90 days to allow for a longer monitoring
period between replacement of the sensor. We believe it is important
for beneficiaries to have continued access to this service during the
transition from a 90- to 180-day monitoring period where the 90-day
sensor may become obsolete. Therefore, effective July 1, 2022, HCPCS
codes G0308 and G0309 are contractor priced. We solicited information
and invoices from interested parties on the costs of the 180-day
interstitial glucose supply and 180-day smart transmitter equipment
direct PE inputs for HCPCS codes G0308 and G0309 to ensure proper
payment for these physician's services, for consideration of national
payment amounts for CY 2023. We noted that the 90-day supply item,
SD334, is currently priced at $1,500 based on information we received
from interested parties. The 90-day smart transmitter, EQ392, is
currently priced at $1,000 and assigned a time value of 25,290 minutes
derived from 60 minutes per hour times 24 hours per day times 90 days
per billing quarter divided by 1 minute of equipment use of every 5
minutes of time. HCPCS code G0308 includes the smart transmitter and
interstitial glucose sensor and HCPCS code G0309 includes the
interstitial glucose sensor only.
Comment: Commenters supported our creation of G codes G0308 and
G0309 to describe the new 180-day interstitial continuous glucose
monitor. Commenters also requested that we
[[Page 69524]]
delete the G codes effective January 1, 2023 and revalue CPT codes
0446T and 0448T to include direct PE costs for the new sensor and
transmitter, since the current 90-day sensor and transmitter has become
obsolete. We also received invoices and pricing information from a
commenter to support their requested PE revaluation.
Response: We agree with commenters that we should delete G codes,
G0308 and G0309, effective January 1, 2023 to ensure accurate payment
for the new 180-day Continuous Glucose Monitoring device. We also agree
to revalue the PE inputs for the existing CPT codes, 0446T and 0448T.
The invoices that we received from a commenter list a supply increase
(SD334) from $1,500 to $3,000, which would be a supply input for both
0446T and 0448T. The invoices also list the equipment (EQ392) as having
an increase in equipment minutes, but not a change in the cost of the
transmitter itself. The increase in equipment minutes applies only to
CPT code 0446T. The physician work remains the same for both codes,
therefore there is no change to work RVUs.
In consideration of the comments and invoices received, we are
finalizing changes to codes G0308, G0309, 0446T, and 0448T. G codes
G0308 and G0309 will be deleted effective January 1, 2023. CPT codes
0446T and 0448T will have supply input SD334 valued at $3,000. CPT code
0446T equipment EQ392 will have equipment minutes equal to 60 minutes *
24 hours * 30 days * 6 months/1 out of every 5 minutes = 51,840
minutes.
(33) Chronic Pain Management and Treatment (CPM) Bundles (HCPCS G3002
and G3003, Formerly GYYY1 and GYYY2, Respectively)
(a) Background and Proposal
In the CY 2022 PFS proposed rule (86 FR 39104, 39179 through
39181), we solicited comments on and explored refinements to the PFS
that would appropriately value chronic pain management and treatment
(CPM) for the purpose of future rulemaking. In our solicitation, we
described Federal efforts for more than a decade to effectively address
pain management as a response to the nation's overdose crisis,\10\ such
as the National Pain Strategy \11\ and the HHS Pain Management Best
Practices Inter-Agency Task Force (PMTF) Report.\12\ As we noted in our
CY 2022 comment solicitation, several sections of the Support for
Patients and Communities Act of 2018 \13\ (SUPPORT Act) describe
actions the Department of Health and Human Services has been directed
to take to improve pain care, such as section 2003, which amended
Medicare's Annual Wellness Visit \14\ to include a review of factors
for evaluation related to pain for patients using opioid medications;
section 6086, the Dr. Todd Graham Pain Management Study; \15\ and
section 6032, which required CMS to furnish a Report to Congress and
develop a related Action Plan to review coverage and payment policies
in Medicare and Medicaid related to the treatment of opioid use
disorder and for non-opioid therapies to help manage acute and chronic
pain.\16\ In the section 6032 Report and the Action Plan, CMS included
a recommendation to explore the possibility of establishing a new
bundled payment under the Medicare Physician Fee Schedule for
integrated multimodal pain care that could include certain elements
such as diagnosis, a person-centered plan of care, care coordination,
medication management, and other aspects of pain care.
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\10\ https://www.hhs.gov/overdose-prevention/.
\11\ https://www.iprcc.nih.gov/sites/default/files/documents/NationalPainStrategy_508C.pdf.
\12\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
\13\ https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf.
\14\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
\15\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\16\ https://www.cms.gov/sites/default/files/2022-4/SUPPORT%206032%20Action%20Plan_Final_061521_Clean.pdf.
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As described in Goal 3 of CMS' 2022 Behavioral Health Strategy \17\
(Strategy), CMS intends to improve the care experience for individuals
with acute and/or chronic pain, expand access to evidence-based
treatments for acute and chronic pain, and increase coordination
between primary and specialty care through payment episodes,
incentives, and payment models. In late 2019, the CMS Office of Burden
Reduction & Health Informatics launched the ``Chronic Pain Stakeholder
Engagement,'' which focused on understanding access to covered
treatment and services for people living with pain. \18\ CMS recently
released information gathered from interested parties through this
Engagement using qualitative research methods and the human-centered
design process, to uncover provider burden, and identify opportunities
to improve access to covered services by illustrating the experiences
of people living with, and treating, chronic pain. The intent of this
project was to highlight the most prominent barriers people with pain
face in accessing care, and the factors influencing clinicians that can
affect people with chronic pain, the quality of their care, and their
quality of life.
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\17\ https://www.cms.gov/cms-behavioral-health-strategy.
\18\ https://www.cms.gov/About-CMS/OBRHI.
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In the context of the Biden-Harris' Administration's commitment to
equity,\19\ and the inclusion of equity as a pillar of CMS' Strategic
Vision,\20\ disparities exist in pain treatment due to bias in
treatment, language barriers, cultural norms, and socioeconomic status.
We are also aware that pain is a factor in suicidality and suicide,
prioritized in the Surgeon General's Call to Action to Implement the
National Strategy for Suicide Prevention \21\ and in HHS' work to
implement ``988'',\22\ the new national dialing code for suicide and
crisis assistance that was implemented nationally this year.
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\19\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
\20\ https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
\21\ https://www.hhs.gov/sites/default/files/sprc-call-to-action.pdf.
\22\ https://www.samhsa.gov/find-help/988.
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In coordination with all of these initiatives, we also have
continued to explore refinements to the PFS that would appropriately
value CPM. In the CY 2022 PFS proposed rule, we sought comment on
whether we should approach CPM through a standalone code or E/M add-on
coding, and about the specific activities that are involved in CPM, how
we might value such a code or service, the settings where this care is
provided, the types of practitioners that furnish this care, and
whether the service or any components of it could or should be
furnished as ``incident to'' \23\ services under the direction of the
billing practitioner by other members of the care team (86 FR 39182).
We received just under 2,000 comments on this comment solicitation,
including comments from provider associations, federations, and
societies that represent health care professionals; organizations that
educate, connect, and advocate for people with pain; State-based health
care organizations, medical societies and associations; cancer care
centers; health care companies; device manufacturers; pain care
providers; and people living with pain. Almost all commenters were
supportive of our efforts to carefully consider an approach to coding
and payment for care for CPM. Many commenters supported the creation of
separate coding and payment for CPM under the PFS. We summarized
[[Page 69525]]
these comments, expressed appreciation for the commenters' attention to
informing our approach to payment and coding for comprehensive CPM
services, and thanked the commenters for their comments in the CY 2022
PFS final rule (86 FR 65129).
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\23\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se0441.pdf.
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Generally, commenters agreed that efforts are needed to effectively
support the complex needs of beneficiaries with chronic pain.
Commenters emphasized that there are numerous conditions giving rise to
chronic pain and that people presenting with chronic pain respond
variably to various treatment modalities, and often require longer
office visit times, and longer follow-up coordinating care with social
workers and case managers, mental and behavioral health support,
communications with emergency department physicians and nurses, and
numerous medication adjustments. One commenter stated that
beneficiaries with complex chronic pain conditions may require a lot of
time for correct dosing of medications and counseling, and that such
time is not captured effectively using existing E/M codes. This
commenter also believed that separate coding and payment for chronic
pain management could help with better understanding of the treatment
of chronic pain than when the service is reported with existing visit
codes and would allow for valuation based on the resources involved in
furnishing these specific services to people with chronic pain,
enhancing the likelihood of appropriate payment, especially for non-
face-to-face time involved with the service.
A few commenters expressed preference for using existing E/M codes
and the creation of codes to be used in conjunction with E/M codes. One
commenter suggested that CMS either clarify or modify existing codes so
they can support services for patients with chronic pain or significant
acute pain, as well as beneficiaries with a chronic disease and a
behavioral health condition, stating that using the existing codes
would avoid any concerns about overpayment for patients with both a
chronic disease and pain, while also making it more feasible for small
practices to employ care management staff and provide customized care
management services for all the patients who need them.
One commenter who was agreeable with various approaches to payment
suggested that the guidelines for Cognitive Assessment and Care Plan
Services code 99483 include ``chronic pain syndromes'' in the
``assessment of factors that could be contributing to cognitive
impairment'' and that these codes could be reported by physicians who
consult with a pain specialist about their patient's pain. This
commenter also suggested that Transitional Care Management could also
potentially include pain management following inpatient care to help
prevent acute pain from progressing to chronic pain. Other commenters
also likened CPM services to chronic care management services. We
believe that chronic care management codes, which, except for Principal
Care Management, specify that the chronic condition being managed is
expected to last at least one year or until death, would not properly
describe the condition of many beneficiaries with chronic pain, which
could potentially improve with treatment and intervention, or recur
after improvement. For example, the 11th revision of the World Health
Organization's International Classification of Diseases and Related
Health Problems define chronic pain as persistent or recurring pain
lasting longer than 3 months.\24\
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\24\ https://icd.who.int/en.
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Commenters included feedback about other specific activities
involved in the management of patients with chronic pain in addition to
those we specified in the comment solicitation. Commenters also
identified codes that CMS might examine as models for payment, either
as stand-alone timed codes or monthly bundles. Commenters suggested
which practitioners should be able to bill such CPM codes, which
practitioners should be able to furnish CPM services incident to the
services of a physician or other practitioner, and expressed views on
adding CPM services to the Medicare Telehealth Services List and
obtaining beneficiary consent for CPM services.
We agree with commenters who believe that E/M codes may not reflect
all the services and resources required to furnish comprehensive,
chronic pain management to beneficiaries living with pain. While we
agree in principle that it might be appropriate to establish bundled
all-inclusive coding with monthly payment for a broader set of CPM
services, we do not have data at the present time on the full scope of
services and resource inputs involved in care for patients with chronic
pain to support development of a proposed monthly bundled all-inclusive
rate. We do believe that E/M codes do not appropriately reflect the
time and other potential resources involved in furnishing comprehensive
CPM for beneficiaries with chronic pain. Beginning in the CY 2014 PFS
final rule (78 FR 74414 through 74427), we recognized that the
resources involved in furnishing comprehensive care to patients with
multiple chronic conditions are greater than those required to support
care in a typical E/M service. In response, we finalized a separately
payable HCPCS code G0316 (Chronic Care Management (CCM) services
furnished to patients with multiple (2 or more) chronic conditions
expected to last at least 12 months, or until the death of the patient;
20 minutes or more per in 30 days of chronic care management services
provided by clinical staff and directed by a physician or other
qualified health care practitioner). The following year, in the CY 2015
PFS final rule (79 FR 67715 through 67730), we refined aspects of the
existing CCM policies and adopted separate payment for CCM services
under CPT code 99490 (Chronic care management services (CCM), at least
20 minutes of clinical staff time directed by a physician or other
qualified health professional, per calendar month, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient; Chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; Comprehensive care
plan established, implemented, revised, or monitored). In the CY 2017
PFS final rule (81 FR 80244), we adopted CPT codes 99487 (Complex
chronic care management (CCCM) services with the following required
elements: Multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient, chronic conditions
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored, moderate or high
complexity medical decision making; first 60 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month) and 99489 (CCCM services with the
following required elements: Multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient,
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, comprehensive
care plan established, implemented, revised, or monitored, moderate or
high complexity medical decision making; each additional 30 minutes of
clinical staff time directed by a physician or other qualified health
care professional,
[[Page 69526]]
per calendar month (List separately in addition to code for primary
procedure)). Then, in the CY 2019 PFS final rule (83 FR 59577), we
adopted a new CPT code, 99491 (CCM services, provided personally by a
physician or other qualified health care professional, at least 30
minutes of physician or other qualified health care professional time,
per calendar month, with the following required elements: Multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient; chronic conditions place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline; comprehensive care plan established, implemented,
revised, or monitored), to describe at least 30 minutes of CCM services
performed personally by a physician or NPP. In the CY 2020 PFS final
rule (84 FR 62690), we established payment for an add-on code to CPT
code 99490 by creating HCPCS code G2058 (CCM services, each additional
20 minutes of clinical staff time directed by a physician or other
qualified healthcare professional, per calendar month). We also created
two new HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694),
representing comprehensive services for a single high-risk disease
(that is, principal care management). In the CY 2021 PFS final rule (85
FR 84639), we finalized a RUC-recommended replacement code for HCPCS
code G2058 with the identical descriptor, CPT code 99439, and assigned
the same valuation as for G2058. For CY 2022, the RUC resurveyed the
CCM code family, including CCCM and Principal Care Management (PCM),
and added five new CPT codes: 99437 (CCM services each additional 30
minutes by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure)), 99424 (PCM services for a single high-risk disease first
30 minutes provided personally by a physician or other qualified health
care professional, per calendar month), 99425 (PCM services for a
single high risk disease each additional 30 minutes provided personally
by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure), 99426 (PCM, for a single high-risk disease first 30 minutes
of clinical staff time directed by physician or other qualified health
care professional, per calendar month), and 99427 (PCM services, for a
single high-risk disease each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure)).
The CCM/CCCM/PCM code family now includes five sets of codes, each
set with a base code and an add-on code. The sets vary by the degree of
complexity of care (that is, CCM, CCCM, or PCM), who directly performs
the services (that is, clinical staff, or the physician or NPP), and
the time spent furnishing the services. The RUC-recommended values for
work RVUs and direct PE inputs for these codes in CY 2022 were derived
from a recent RUC specialty society survey. We proposed to accept the
RUC-recommended values, considered public comments, and finalized the
proposed values for the 10 CCM/CCCM/PCM codes.
In consideration of the supportive comments we received last year
in response to our comment solicitation, clinical expertise within CMS,
and internal input from CMS staff and from our HHS operating division
partners, we proposed to create separate coding and payment for CPM
services beginning January 1, 2023. We recognize that there is
currently no existing CPT code that specifically describes the work of
the clinician who performs comprehensive, holistic CPM. We also believe
the resources involved in furnishing CPM services to beneficiaries with
chronic pain are not appropriately recognized under current coding and
payment mechanisms. As noted above, we do not believe that E/M codes
and values appropriately reflect time involved in furnishing CPM for
beneficiaries with chronic pain. CMS has authority under section 1848
of the Act to establish codes that describe services furnished by
clinicians and suppliers that bill for physicians' services, and to
establish payment amounts for those services that reflect the relative
value of the resources involved in furnishing them. We also expect that
creating separate coding and payment for CPM will help facilitate the
development of data regarding the prevalence and impact of chronic pain
in the Medicare population, where conditions including osteoarthritis,
cancer, and other similar conditions that cause pain over extended
periods of time are common.\25\ Such information can assist us in
identifying potential coding and valuation refinements to ensure
appropriate payment for these services. We also believe that the
comprehensive care management involved in CPM services may potentially
prevent or reduce the need for acute services, such as those due to
falls \26\ and emergency department care \27\ associated with chronic
pain--for example, sickle cell disease or migraine pain--and also have
the potential to reduce the need for treatment for concurrent
behavioral health disorders, including substance use disorders. There
is some evidence that addressing chronic pain early in its course may
result in averting the development of ``high-impact'' chronic pain \28\
in some individuals; these people report more severe pain, more
difficulty with self-care, and higher health care use than others with
chronic pain.
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\25\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CC_Main.
\26\ https://www.cdc.gov/falls/facts.html.
\27\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\28\ https://www.sciencedirect.com/science/article/pii/S1526590018303584?via%3Dihub.
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There are various definitions for chronic pain from, for example,
the Centers for Disease Control and Prevention \29\ and the National
Institutes of Health,\30\ and in the Institute of Medicine's (IOM)
``Relieving Pain in America: A Blueprint for Transforming Prevention,
Care, Education, and Research'',\31\ and in the World Health
Organization International Classification of Disease Edition 11,--most
define chronic pain consistently, with some variation, as pain that
persists longer than 3 months. The CDC, for example, has defined
chronic pain within its 2016 opioid prescribing Guideline as ``pain
that typically lasts >3 months or past the time of normal tissue
healing, and can be the result of an underlying medical disease or
condition, injury, medical treatment, inflammation, or an unknown
cause.'' For clarity and operational use, we proposed to define chronic
pain as ``persistent or recurrent pain lasting longer than 3 months.''
We welcomed comments from the public regarding whether this was an
appropriate definition of chronic pain, or whether we should consider
some other interval or description to define chronic pain. We were also
interested in hearing from commenters about how the chronic nature of
the person's pain should be documented in the medical record.
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\29\ https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf.
\30\ https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.
\31\ https://www.ncbi.nlm.nih.gov/books/NBK92525/#ch1.s3.
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We posited a monthly payment approach may also be more financially
straightforward from the standpoint of
[[Page 69527]]
beneficiaries receiving treatment for chronic pain, particularly with
respect to applicable coinsurance, which is generally 20 percent of the
payment amount, after the annual Part B deductible amount is met.\32\
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\32\ https://www.medicare.gov/what-medicare-covers/what-part-b-covers.
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Beginning for CY 2023, we proposed to create two HCPCS G-codes to
describe monthly CPM services. The codes and descriptors for the
proposed G-codes are:
HCPCS code G3002: Chronic pain management and treatment,
monthly bundle including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and/or maintenance of a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes; overall treatment management; facilitation and
coordination of any necessary behavioral health treatment; medication
management; pain and health literacy counseling; any necessary chronic
pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.
physical therapy and occupational therapy, and community-based care, as
appropriate. Required initial face-to-face visit at least 30 minutes
provided by a physician or other qualified health professional; first
30 minutes personally provided by physician or other qualified health
care professional, per calendar month. (When using G3002, 30 minutes
must be met or exceeded.)
HCPCS code G3003: Each additional 15 minutes of
chronic pain management and treatment by a physician or other qualified
health care professional, per calendar month. (List separately in
addition to code for G3002. When using G3003, 15 minutes must be met or
exceeded.)
We were interested in hearing from commenters regarding our
proposed inclusion of ``administration of a validated pain assessment
rating scale or tool,'' as an element of the proposed CPM services, and
including it within the descriptor of the proposed HCPCS code G3002. We
also solicited comment on whether a repository or list of such tools
would be helpful to practitioners delivering CPM services.
We proposed to include, as an element of the CPM codes, the
development of and/or revisions to a person-centered care plan that
included goals, clinical needs, and desired outcomes, as outlined above
and maintained by the practitioner furnishing CPM services.
We proposed to include health literacy counseling as an element of
the CPM codes, because we believe it will enable beneficiaries with
chronic pain to make well-informed decisions about their care,
increases pain knowledge, and strengthens self-management skills.
Health literacy is the degree to which individuals have the ability to
find, understand, and use information and services to inform health-
related decisions and actions for themselves and others.\33\ Adequate
health literacy may improve the person's capability to take
responsibility for their health, including pain-related health issues
such as adherence to treatment regimens and medication administration,
and have a positive influence on health outcomes, and health
disparities. CMS' Network of Quality Improvement and Innovation
Contractors have used health literacy counseling to improve health
counseling,\34\ and health literacy counseling has been used to treat
arthritis.\35\ We noted in the proposed rule that we were interested in
hearing from commenters about how pain and health literacy counseling
is or may be effectively used as a service element to help
beneficiaries with chronic pain make well-informed decisions about
their own care, weigh risks and benefits, make decisions, and take
actions that are best for them and their health.
---------------------------------------------------------------------------
\33\ https://health.gov/healthypeople/priority-areas/health-
literacy-healthy-people-
2030#:~:text=Health%20literacy%20is%20a%20central,well-
being%20of%20all.%E2%80%9D.
\34\ https://qi.ipro.org/health-equity/health-literacy/.
\35\ https://www.ahrq.gov/health-literacy/improve/precautions/1stedition/tool3.html.
---------------------------------------------------------------------------
For HCPCS code G3002, we proposed to include an initial face-to-
face visit of at least 30 minutes, provided by a physician or other
qualified health professional, to a beneficiary who has chronic pain,
as defined above, or is being diagnosed with chronic pain that has
lasted more than 3 months at the time of the initial visit. After
consultation with our medical officers, we believe the management of a
new patient with chronic pain would involve an initial face-to-face
visit of at least 30 minutes due to the complexity involved with the
initial assessment. We believe follow-up or subsequent visits could be
non-face to face. HCPCS code G3003 describes an additional 15 minutes
of CPM and treatment by a physician or other qualified health care
professional, per calendar month (listed separately in addition to
G3002). We solicited comment on the appropriateness of the proposed 30-
minute duration per calendar month for G3002, and also on the proposed
duration and frequency for G3003. We also solicited comment on whether
we should consider specifying a longer duration of time for G3002 (for
example, one hour--or 45 minutes). Similarly, we solicited comment on
whether we should consider specifying a longer duration of time for
G3003 (for example, 20-minute increments). We also welcomed comment on
our proposal to permit billing of CPM services for beneficiaries who
have already been diagnosed with chronic pain, and for people who are
being diagnosed with chronic pain during the visit.
We welcomed comments regarding how best the initial visit and
subsequent visits should be conducted (for example, in-person, via
telehealth, or the use of a telecommunications system, and any
implications for additional or different coding). We also considered
whether to add the CPM codes to the Medicare Telehealth Services List,
based on our review of any information provided through the public
comments and our analysis of how these new services may be
appropriately furnished to Medicare beneficiaries. We also requested
comment regarding whether there are components of the proposed CPM
services that do not necessarily require face-to-face interaction with
the billing practitioner, such as care that could be provided by
auxiliary staff incident to the billing practitioner's services. For
any components that could be furnished incident to the services of the
billing practitioner, we requested comment on whether these could be
appropriately furnished under the general supervision of the billing
physician or non-physician practitioner (NPP), for example,
administration of a pain rating scale or tool, or elements of care
coordination, as we have provided for certain care management services.
We believe that most CPM services would be billed by primary care
practitioners who are focused on long-term management of their patients
with chronic pain. As calls for improved pain management have increased
in recent years, this has resulted in better education and training of
primary care practitioners and heightened awareness of the need for
pain care nationally. We believe the codes we proposed for CPM services
will create appropriate payment for physicians and other practitioners
(beyond primary care practitioners) that reflects the time and
resources involved in attending comprehensively to the needs of
beneficiaries with chronic pain. As the IOM ``Blueprint'' report noted,
even people who need consultation with a pain specialist
[[Page 69528]]
should benefit from the sustained involvement of a primary care
practitioner who is able to help coordinate care across the full
spectrum of health care providers, as such coordination ``helps prevent
people from seeking relief from multiple providers and treatment
approaches that may leave them frustrated and angry and worse off both
physically and mentally, and from falling into a downward spiral of
disability, withdrawal, and hopelessness.'' \36\ The Blueprint stated
that this type of fragmentation hinders the development of a strong,
mutually trusting relationship with a single health professional who
takes responsibility, and that this established relationship is one of
the keys to successful pain treatment. We anticipated that if these
proposed codes are finalized, primary care practitioners will employ a
variety of person-centered pain management strategies, such as those
suggested in the PMTF Report and illustrated in CMS' CPM graphic \37\
including medications, therapies, exercise, behavioral health
approaches, complementary and integrative health, and community-based
care based on the complexity, goals, and characteristics of each person
they serve with chronic pain and according to the person-centered plan
of care. It is also important to note that, in many parts of the
country, people have access only to their primary care practitioner for
chronic pain care.\38\ We understand, however, the need or desire that
some individuals with chronic pain have to be seen on an ongoing basis
for CPM by a pain specialist who has received special training and/or
certification to meet the needs of the most complex and challenging
patients with chronic pain.
---------------------------------------------------------------------------
\36\ https://www.ncbi.nlm.nih.gov/books/NBK91497/.
\37\ https://www.cms.gov/files/document/cms-chronic-pain-journey-map.pdf.
\38\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
---------------------------------------------------------------------------
Therefore, we proposed to permit billing by another practitioner
after HCPCS code G3002 has already been billed in the same calendar
month by a different practitioner. In these situations, we anticipate
that there could be occasional instances where care of an individual
with chronic pain is transferred to a pain specialist or other
specialist during the same month they received the CPM services from a
primary care practitioner, for ongoing care. In these or other
situations (such as when the beneficiary elects to choose a different
physician or practitioner to furnish CPM services), we would anticipate
G3002 and potentially G3003 could be billed by another practitioner
during the same month, for the same beneficiary. We believe that it
would be unlikely for G3002 to be billed more than twice per month
under such circumstances and proposed placing a limit on the number of
times the code could be billed per beneficiary per calendar month, at a
maximum of twice per calendar month. We solicited comment on our
proposal to permit billing by another practitioner after the G3002 has
already been billed in the same month by a different practitioner, and
on the number of times the code could be appropriately billed per
month, per beneficiary.
We proposed to require that the beneficiary's verbal consent to
receive CPM services at the initiating visit be documented in the
beneficiary's medical record, as not all Medicare beneficiaries with
chronic pain eligible to receive these separately billable CPM services
may understand or want to receive these services, and the beneficiary
should be aware that they are receiving them. At the initial visit, the
beneficiary with chronic pain should be educated regarding what the CPM
services are, how often they may generally expect to receive the
services, and have an explanation of any cost sharing that may apply in
their particular situation. Practitioners have informed us that
beneficiary cost sharing is a significant barrier to provision of
similar care management services, such as CCM services, and we
solicited comment on how best to effectively educate both practitioners
and beneficiaries with chronic pain about the existence of, and the
benefits and value of, the proposed CPM services. We solicited comment
regarding whether the initiating visit is the appropriate time for
billing practitioners to obtain beneficiary verbal consent, if consent
should be given at each visit, and also if beneficiary consent should
be sought by the practitioners with whom CPM billing practitioners
coordinate other Medicare services under the CPM plan of care, or even
more broadly.
We believe there might be some potential for duplicative payment
for services allocated to the same patient concurrent with certain
other Medicare care management services, such as CCM or behavioral
health integration (BHI) services; however, we believe the proposed CPM
codes have features that would mitigate such circumstances, such as the
elements of the service that specifically address the beneficiary's
pain--for example, the administration of a validated pain rating scale
or tool. We welcomed comments regarding what, if any, Medicare services
we should consider that could not be billed by the same practitioner
for the same patient concurrent with any other Medicare services, to
avoid duplication of payment, and help limit financial burden to the
Medicare beneficiary with chronic pain. We noted that we would expect
to refine these codes as needed through future rulemaking as we receive
more information how the codes are being used, and how they are
implemented in practice.
To the extent that components of the proposed CPM codes are also
components of other care management services, we reiterate our policy
against double-counting time and require that the time used in
reporting CPM services may not represent time spent in any other
reported service. We proposed that the CPM codes could be billed in the
same month as a care management service, such as CCM, or BHI. We
believe there are circumstances in which it is reasonable and necessary
to provide both services in a given month, based on the needs of the
Medicare beneficiary with chronic pain, for example, when the
beneficiary has both chronic pain, and a mental disorder(s), or
multiple chronic conditions. We also proposed that the CPM codes would
be able to be billed for the same Medicare patient in the same month as
another bundled service such as HCPCS Codes G2086-G2088, which describe
bundled payments under the PFS for opioid use disorders. We noted that
patient consent would need to be obtained for both of the bundled
services such as, for example, CPM and BHI, and all other requirements
to report CPM and to report the other service or services would need to
be met. We invite comments on these billing proposals and their
appropriateness in the context of CPM.
Finally, we questioned commenters whether we should consider
creating additional coding and payment to address acute pain. We are
interested in information regarding a definition for acute pain,
standalone or E/M coding, the specific activities that could be
furnished, how we might value and price such a code or service, the
settings where care should be provided, the types of practitioners that
should furnish acute pain care, if the service or any components should
be furnished as ``incident to'' services under the direction of the
billing practitioner or by other members of the care team, and other
information that might help us in proposing such a code or codes.
[[Page 69529]]
(b) Valuation of Chronic Pain Management Services
Consistent with the valuation methodology for other services under
the PFS, proposed HCPCS codes G3002 and G3003 would be valued based on
what we believe to be a typical case, and we understand that, based on
variability in patient needs, some patients will require more
resources, and some fewer. The proposed CPM codes would separately pay
for a specified set of CPM elements furnished during a month, including
the administration of validated rating scales, establishment and review
of a person-centered care plan that includes goals, clinical needs, and
desired outcomes, and other elements as described in the proposed code
descriptors. To value CPM, we compared the proposed services to codes
that involve care management. In doing so, we concluded that the CPM
services were similar in work (time and intensity) to that of PCM in
that both the PCM codes and proposed CPM codes reflect services that
have similar complexities, possible comorbidities, require cognitive
time on the part of the practitioner, and may involve coordination of
care across multiple practitioners.
For HCPCS code G3002, we developed proposed inputs using a
crosswalk to CPT code 99424 (Principal care management services, for a
single high-risk disease, with the following required elements: One
complex chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/decompensation, functional decline, or death; the
condition requires development, monitoring, or revision of disease-
specific care plan; the condition requires frequent adjustments in the
medication regimen and/or the management of the condition is unusually
complex due to comorbidities; ongoing communication and care
coordination between relevant practitioners furnishing care; first 30
minutes provided personally by a physician or other qualified health
care professional, per calendar month.), which is assigned a work RVU
of 1.45. Additionally, for G3002 we proposed to use a crosswalk to the
direct PE inputs associated with CPT code 99424. We believe that the
work and PE described by this crosswalk code is analogous to the
services described in G3002, because G3002 includes similar care plan,
medication management, unusually complex clinical management; care
coordination between relevant practitioners furnishing care; and time
for care provided personally by a physician or other qualified health
care professional, as described in CPT code 99424.
We proposed to value G3003 at a work RVU of 0.50, using a crosswalk
to CPT code 99425 (each additional 30 minutes provided personally by a
physician or other qualified health care professional, per calendar
month) (List separately in addition to code for G3002), which is
assigned a work RVU of 1.00. However, the required minimum number of
minutes described in G3003 is half of the number of minutes in CPT code
99425. For HCPCS code G3003, we proposed to use a crosswalk to half of
the direct PE inputs associated with CPT code 99425. We believe that
the work and PE described by this crosswalk code is analogous to the
services described in G3003, because G3003 includes similar activities
as described in CPT code 99425.
We proposed that G3002 can only be billed when the full 30 minutes
of service time has been met or exceeded. Additionally, we proposed
that the add-on code (G3003) can only be billed when the full 15
minutes of service time is met or exceeded.
Our proposed valuation of CPM services includes services that are
personally performed by a physician (or other appropriate billing
practitioner, such as a nurse practitioner (NP) or physician assistant
(PA)) described by certain E/M visit codes that apply to a new patient
in various settings. Accordingly, we proposed that G3002/G3003 must be
furnished by the physician (or other appropriate billing practitioner)
and could not be billed on the same date of service as CPT codes 99202-
99215 (Office/outpatient visits new), since these codes reflect face-
to-face services furnished by the physician or other billing
practitioner for related, separately billable services that are being
furnished to a patient the practitioner has not previously seen. We
believe it would be unlikely the practitioner is prepared to address
the complex pain needs of a new patient on the same day he or she is
seen for a general visit, or a visit where the person is being seen for
some other illness or condition. We do not believe that the services
included in G3002/G3003 would significantly overlap with CCM services;
Transitional Care Management (TCM) services; or BHI services, which
have various clinical purposes separate from CPM. We do believe there
is likely overlap in the Medicare beneficiary population eligible to
receive CCM, TCM, BHI, and the proposed CPM services, but we believe
there are distinctions in the nature and extent of the assessments,
care coordination, medication management, and care planning for CPM to
allow concurrent billing for services that are medically reasonable and
necessary, and that it is particularly important to allow for the
provision of needed services, including behavioral health services, to
beneficiaries with chronic pain. We solicited comment on whether we
have appropriately identified the codes Medicare should not pay if
furnished during the same day as the proposed CPM codes, and if there
are circumstances where multiple care planning codes could be furnished
without overlap or other situations, such as where the practitioner is
seeing a new patient.
We noted that the proposed CPM codes would be limited to
beneficiaries in office or other outpatient or domiciliary settings. We
will consider for future rulemaking separately identifying and paying
for CPM services furnished to beneficiaries in any appropriate setting
of care, in recognition of the prevalence and burden of pain across all
settings of care, and the associated time and service complexity to
provide care for chronic pain. We appreciate comments on other settings
where CPM services could be provided.
(c) Request for Comment
We believe there could be circumstances in which a beneficiary
receiving CPM services needs referrals or recommendations, based on a
clinician's assessment, for services or interventions that are not
included as elements of the CPM services, such as for community-based
care or physical and occupational therapy. We welcomed comments on the
care coordination that may occur between relevant practitioners
furnishing services, such as complementary and integrative care, and on
the community-based care element included in the descriptors for
proposed G3002 and G3003.
We also asked commenters to weigh in on how documentation of the
performance of the elements of CPM services might best be addressed in
medical recordkeeping. We solicited general comment on whether there
are any elements of CPM services outlined in this proposal that the
public and interested parties believe are not typically furnished in
connection with comprehensive chronic pain management, or any proposed
elements of the CPM services that should be removed or altered. We
solicited comment on whether there are elements
[[Page 69530]]
of CPM services that we have not identified and should be added to the
code descriptors.
Additionally, we solicited comment on which, if any, CPM elements
could be furnished as ``incident to'' services, and whether to add
G3002 and G3003 to the list of services for which we allow general
supervision as described in our regulation at Sec. 410.26(b)(5). We
welcomed comments from the public for future rulemaking regarding what
elements of the CPM services could be furnished under general
supervision, or direct supervision. For example, facilitation and
coordination of any necessary behavioral health treatment, chronic pain
related crisis care, and ongoing communication and care coordination
between relevant practitioners furnishing care might be appropriate
activities to be considered under general supervision.
The proposed CPM codes may involve arrangements where the physician
or other health professional might work in collaboration with other
health care providers or members of a care team, such as a
psychologist, dental practitioner, or social worker, where these
individuals might furnish certain elements of the service bundle under
the direction of the physician or qualified health practitioner, such
as assessments, person-centered care planning, referrals to community-
based care, and other activities, as appropriate. We requested comments
on if, and how, we should structure the proposed CPM code and payment
for these services to account for these types of arrangements that
could include team-based care.
We received over 150 unique comments on our proposal from national
health care organizations including provider associations, federations,
and societies that represent health care professionals; organizations
that educate, connect, and advocate for people with pain; State-based
health care organizations, medical societies and associations; cancer
care centers; health care companies; hospice and palliative care
organizations; device manufacturers; pain care providers; and people
living with pain and their caregivers. Almost all commenters were
supportive of our proposal. We also received several comments mainly
from psychologists or psychology associations, requesting we adopt
additional coding without medication management in the code descriptor,
as medication management in most states is outside the scope of a
psychologist's license. The following is a summary of the comments we
received and our responses.
Comment: Commenters living with chronic pain and their caregivers
shared poignant stories about the importance of the proposed codes. One
person observed that in recent years, since the release of the Centers
for Disease Control and Prevention's (CDC) Guideline for Prescribing
Opioids, for people taking opioid medications or for those who were
forced to stop taking medications, the relationship between providers
and patients has become fraught, tense, and stigmatizing, even risky
for physicians and for all these reasons, many clinicians have refused
to treat chronic pain patients or have terminated chronic pain patients
from their practices, with growing numbers of pain patients unable to
find anyone to treat them, even if they do not use opioid medications.
The spouse of a person living with chronic pain told of repeated trips
to a local hospital seeking emergency treatment that worsened, instead
of improved, her care, in part because the couple believed clinicians
at the hospital were fearful of prescribing opioids and did not have
access to, or ignored, the recommendations of the patient's longtime
clinicians, who included several pain specialists. A beneficiary who
lives with chronic pain stated that she hoped the change in codes would
motivate clinicians to focus more attention on people with pain, as
after many years of seeing provider inexperience first-hand, along with
the accompanying administrative demands and paperwork pain care
demands, she believed having a special billing code will be a ``giant
step'' forward for people with pain, potentially allowing more people
like her with painful conditions to continue to contribute to society,
including through employment. A person living with chronic pain stated
he liked what he saw in the code proposal because he hoped it would
open the doors to more doctors who would provide pain care, including
appropriate medication management, because he thinks doctors are still
fearful of Federal and State prescribing guidelines. Another person
living with pain stated the CPM services are ``so needed by people like
me.''
One commenter noted that they would expect that the amount of pain
care required and the cost to Medicare to be large and increasing,
especially given the aging American population and the prevalence of
age-associated chronic pain conditions in Medicare like arthritis,
cancer, and diabetic neuropathy; the same commenter stated that pain
management is complex, and there are no existing codes that account for
all the tasks required to care for a patient with chronic pain, and
that a standalone code will signal to physicians that, when patients
have complaints of pain, it is critical to take them seriously.
Conversely, another commenter was not supportive of the new codes as
they believe that physicians will continue to bill evaluation and
management (E/M) codes to avoid adding to their administrative burden.
One commenter requested that we ``pause'' implementation of the
codes, further engage with interested parties, and make additional
clarifications within the code to address valuation, descriptors, and
guidance. Another commenter noted that they do not support including
the CPM codes in the applicable list used for accountable care
organizations beneficiary assignment, citing that managing chronic pain
does not routinely follow the overall health of the patient, and is
typically managed by clinicians with specific skills beyond primary
care. One commenter questioned if a single bundled code was adequate to
address the breadth of conditions that patients may experience, as well
as the variety of treatment and management approaches. One commenter
urged us to consider that for some people, a visit with a practitioner
might focus not just on pain management, but also whole-person care.
The same commenter noted that, although they appreciated our efforts to
simplify billing requirements for the CCM codes, uptake appears to be
low in part due to administrative burden, and they expressed concerns
that similar challenges would apply to the CPM codes, which could
entail documentation of services rendered in an E/M service. The
commenter asked us if we could determine a pathway to make billing more
streamlined, perhaps through billing using the G89.xx ICD-10 series. A
commenter thanked us for improving access to pain care, including
through prevention and treatment for substance use disorders (SUD). A
different commentator congratulated us on, through creation of the
codes, helping to prevent some individuals from developing SUD. One
commenter noted the codes would prompt more practitioners to welcome
Medicare beneficiaries with chronic pain into their practices, and
encourage practitioners already treating Medicare beneficiaries who
have pain to spend the time to help them manage their condition within
a trusting, supportive, and ongoing care partnership.
Response: We thank all the commenters who expressed enthusiastic
support of the proposed new HCPCS
[[Page 69531]]
codes for CPM services, and we appreciate the attention to informing
our approach in shaping this policy that we believe will provide
improved access to holistic and comprehensive pain management for
people with Medicare. A few commenters disagreed with our proposal. One
commenter stated that our proposal is not substantially different than
existing codes, while another questioned whether one code was
sufficient to address the breadth of conditions patients experiencing
chronic pain face. We do not agree that there is an existing code that
specifically describes the work of the clinician in performing the
specific tasks described in the code descriptor for HCPCS code G3002.
We anticipate that the CPM codes will be used to address the full range
of chronic pain conditions that impact Medicare patients. We look
forward to gaining more knowledge through data, and clinician and
beneficiary experience as use of the CPM codes becomes more frequent.
Comment: We received a few comments regarding our proposal to
define chronic pain as ``persistent or recurrent pain lasting longer
than 3 months.'' Most commenters agreed with our proposed definition.
We received several suggestions related to the specification of 3
months duration, including one month, 90 days, and the addition of
``expected to last longer'' to our definition. A few others suggested
we broaden the definition generally, to ensure that patients with
cancer, neuropathic pain, psychogenic pain, and headaches would also
benefit from this proposal to create HCPCS codes that describe CPM
services, while another commenter congratulated us on using language
that it noted was inclusive of all types of pain treatment. One
commenter asked us to integrate acute pain and biopsychosocial factors
into our definition, and stated that risk indicators of pain are
apparent early, potentially limiting robust interventions for the
prevention of chronic pain. One commenter opined that our definition of
chronic pain was overly broad and did not address the many types of
conditions that pain patients may experience. A commenter who agreed
with our definition noted that in the International Classification of
Disease, 11th edition (ICD-11),\39\ chronic pain has its own diagnosis,
independent of an underlying disease or condition. Still, another
commenter, who also agreed with our definition, noted there are ICD-10
diagnostic codes for chronic pain, the G89.xx series. Another commenter
agreed that the proposed definition is largely in line with their
understanding, adding more context to include, ``persistent or
recurrent pain without a serious progression or exacerbation of an
underlying pathologic condition and without tolerability over time.''
Another commenter stated that at a high level, they believe the metric
of ``time'' is not the dispositive component to define a chronic pain
diagnosis, but the definition should instead take into account a
complex series of associated factors like amount of suffering or
hindrance of function, and that not all recurrent pain should be
considered chronic pain; instead chronic pain as a diagnosis should be
utilized for an individual who does not understand how to manage or
live their life with their current, recurring, episodic symptoms.
---------------------------------------------------------------------------
\39\ https://icd.who.int/en.
---------------------------------------------------------------------------
Response: We appreciate all the commenters' suggestions and
observations. As we described in the proposed rule, we reviewed
definitions from the Centers for Disease Control and Prevention, the
National Institutes of Health, the World Health Organization,\40\ and
in the Institute of Medicine's ``Relieving Pain in America: A Blueprint
for Transforming Prevention, Care, Education, and Research.'' For
operational ease and consistency with the proposed rule and various
sources, we are finalizing as proposed the definition of chronic pain
as ``persistent or recurrent pain lasting longer than 3 months.''
---------------------------------------------------------------------------
\40\ https://painconcern.org.uk/new-classification-for-chronic-
pain/
#:~:text=Chronic%20primary%20pain%20is%20defined,explained%20by%20ano
ther%20chronic%20condition.
---------------------------------------------------------------------------
Comment: One commenter recommended we focus on improving care for
all pain, such as acute pain, as well as pain related to cancer, sickle
cell disease, and for people in palliative care, with another commenter
also agreeing that additional codes could focus on people with
palliative and cancer pain. This commenter noted that increased support
for comprehensive acute pain management could also reduce the number of
patients who progress from acute to chronic pain. This sentiment was
echoed by other commenters, who suggested an additional pain code for
acute care that would incorporate massage therapy and other
complementary and integrative services for both in-patient and
outpatient visits, as is seen in some large health systems. Several
other commenters generally supported the inclusion or addition of acute
pain management in this or other codes. One commenter suggested that
after we gain experience with the use of the codes for chronic pain, we
consider their application to acute pain management. A few commenters
did not support additional coding and payment for acute pain
management, as they believed these circumstances are adequately handled
via existing E/M coding and payment.
Response: As we mentioned in the proposed rule, we understand there
is some evidence that addressing chronic pain early in its course, such
as when the person is experiencing acute pain, may result in averting
the development of ``high-impact'' chronic pain in some individuals and
that these people report more severe pain, more difficulty with self-
care, and higher health care use than others with chronic pain. We
considered, in the development of this code, whether or not to include
acute pain, and elected not to include it in the CPM services
descriptor. We will continue to consider how best to approach
management of acute pain through coding and payment.
In our proposal, we required an initial face-to-face visit of at
least 30 minutes provided by a physician or other qualified health
professional with the first 30 minutes personally provided by the
physician or other qualified health professional, per calendar month
for HCPCS code G3002. We noted that HCPCS codes GYYY1 and GYYY2 were
placeholder codes and that the final code number will be HCPCS code
G3002 and G3003, respectively. We proposed, for HCPCS code G3003, an
additional fifteen minutes of CPM services by a physician or other
qualified health professional, per calendar month, and we proposed
limiting the application of HCPCS code G3003 to up to three units of an
additional 15 minutes of CPM services, per calendar month (listed
separately in addition to proposed HCPCS code G3002). We sought comment
on both the proposed duration of 30 minutes for HCPCS code G3002, and
the duration and the limit on HCPCS code G3003.
Comment: Most commenters agreed that our proposal for 30 minutes
for HCPCS code G3002 was reasonable and adequate for the treatment and
management of the first visit for a person with chronic pain and that
fifteen-minute intervals for subsequent time-based intervals is
adequate.
One commenter expressed a concern that neither code allowed for
adequate time, and that the codes should allow for at least an hour for
the first visit and 45 minutes for subsequent visits, especially to
allow for the intensity of clinical time that would be likely
[[Page 69532]]
needed to diagnose and treat a new patient. The same commenter urged
us, because the myriad of situations that could apply based on the
complexity of treating pain overall in the Medicare population, to
consider additional flexibilities in the duration of time for the codes
based on each person with pain's situation. Another commenter noted
that the time required to coordinate with other specialists, referrals,
therapies, and trial different treatments is ``considerable'' to create
and modify an individual treatment plan for each patient. Another
commenter suggested that twice a month billing for proposed HCPCS code
G3002 is insufficient for completion of the list of requirements, and
recommended that four visits per month be allowed to ensure that the
element list is completed. A separate commenter echoed this sentiment,
suggesting there be no limitation on the number of times per month this
code can be billed, citing the multitude of providers seen by some
patients. Another commenter recommended we consider extending the
length of visits from 45 minutes (30 minutes for proposed HCPCS code
G3002, 15 minutes for proposed G3003) to 60 minutes to account for the
complexity of pain care. A commenter noted that 30 minutes was too high
a threshold for appointments beyond the initial visit, and recommended
that subsequent visits only have a limit of 15 minutes after which
billing is allowed. One commenter stated that we should not put any
limits on the number of times proposed HCPCS code G3003 can be billed
each month. A commenter requested that the frequency and duration of
permitted CPM visits be flexible enough to account for the variety of
practice types--from primary care to specialized clinics offering
intensive and integrated chronic pain management services, and this
commenter also noted that patients have different intensities of need,
with some requiring longer appointments, or at greater frequency, while
some have lower needs, stating that 30 minute and 15 minute durations
of HCPCS codes G3002 and G3003 respectively, as well as the frequency,
may be too limited to adequately account for the challenging demands of
chronic pain management. Another commenter stated that 30 minutes seems
reasonable but flexibility is important as chronic pain conditions vary
and sometimes more than 30 minutes may be needed, especially for a
first visit. Another commenter requested clarification related to the
frequency of allowed billing for CPM codes, as some services such as
comprehensive palliative care require a wide range of care.
Response: We appreciate the commenters' overall support of our
proposal to set the duration of HCPCS code G3002 at 30 minutes, to
accommodate both the specified elements of the monthly bundle, and the
complex needs of the person with chronic pain, and we are finalizing
HCPCS code G3002 for 30 minutes duration. We agree with the commenters
who observed that additional flexibilities are needed to account for
the numerous situations that could apply to each person with pain's
clinical situation, and the factors that might go into the clinician's
determination regarding how much time is appropriate to spend treating
a person with chronic pain, and also how many and what type of
clinicians might need to also furnish care during a particular month.
Although we expect that in most instances the person with chronic pain
would see one clinician on a regular basis who is performing a lead
role in managing that individual's pain, we can also foresee limited
circumstances where a beneficiary may need to have their care
transferred to a pain specialist, or other specialist in the same
month, and the pain specialist or other specialist may also bill HCPCS
code G3002 for the same beneficiary, in the same month. There may also
be situations where the person with chronic pain needs to see two
different clinicians managing their pain on a regular basis, for
example, a cancer specialist and a rheumatologist, with both billing
the CPM code(s). We would not expect many beneficiaries living with
chronic pain would typically be seeing more than one or two physicians
or qualified health professionals in a month who might be performing
HCPCS code G3002; in part, because of the burden of care described by
chronic pain patients and their caregivers, and also because
beneficiaries incur cost-sharing expenses for these services and other
care they receive--typically 20 percent of the Medicare payment amount
after the annual Medicare Part B deductible amount is met.
Based on the comments, especially those that encouraged us to
increase billing flexibilities to account for the unique needs of each
person with chronic pain, we have reconsidered the proposed limit on
billing G3003 to three times per month, and are finalizing in this rule
flexibility to bill the second code, for each additional 15 minutes of
care, an unlimited number of times, as medically necessary, per month,
after HCPCS code G3002 has been billed. We will be monitoring use of
the codes going forward to understand more about how they are being
used.
Comment: One commenter asked if our proposal required the physician
to meet with the patient each month or only once in the initial month
of the service, as the commenter noted that monthly visits with the
physician are not likely to be necessary for some people receiving
ongoing chronic pain management. Another commenter stated that a
monthly visit may be onerous for cancer patients who are already
receiving time-intensive care. A commenter pointed out that it could
take year or more of regular visits to develop, coordinate, and revise
a treatment plan optimal in managing the patient's chronic pain; the
same commenter stated that a patient might drop back to bi-monthly,
quarterly, bi-annually, and annual visits so long as pain is being
effectively managed. Another commenter requested clarification
regarding if all the elements in the descriptor would be required each
month.
Response: We agree with the commenters who noted that each person
with chronic pain may not need to receive the monthly bundle every
month; rather, using a person-centered approach, one which optimizes
care according to individual circumstances and preferences, requires
variability in how often services are appropriately rendered.
Therefore, the CPM services for the HCPCS code G3002 may not be
rendered more than once per month by each individual practitioner
billing the code for each beneficiary, but could be rendered less than
twelve times per year, depending on the specific needs of the person
with chronic pain.
Comment: Some commenters requested clarification on our proposal
that the first time HCPCS code G3002 is billed that initial visit must
be in person, or if subsequent monthly visits must be ``face-to-face,''
or in person. Several commenters recommended that we not make in-person
first time visits an absolute requirement, so as to accommodate for
mobility difficulties for people living a long-distance from the
physician's office. Other commenters recommended that ``face-to-face''
components be available via both video and telecommunication technology
to support access. Several commenters stated that we needed to clarify
that the code required that only the very first visit be in-person, and
that follow-up visits could be delivered in-person, or by telehealth. A
different commenter's concern was that HCPCS code G3002 seemingly
requires an ``initial'' face-to-face visit of at least 30 minutes, and
while the commenter did
[[Page 69533]]
not object to one required initial face-to-face visit at the onset of
CPM treatment, they thought that CMS potentially requiring an in-person
visit monthly is unnecessary, overburdensome, and would exacerbate
health care disparities. One commenter noted an initial visit with the
patient could be supported by telehealth. Another commenter noted that
patients should be seen in the office for the initial visit, at least
until they are regulated on their pain medicines. An additional
commenter requested clarification as to whether a practitioner could
bill these codes both for patients that have an established history of
chronic pain, and those that are being diagnosed as having chronic pain
for the first time.
Response: We thank the commenters for their comments, but we are
finalizing the requirement that the first time HCPCS code G3002 is
billed, the physician or qualified health practitioner must see the
beneficiary in-person, where both individuals are in a clinical setting
such as a primary care practitioner's office or other applicable
setting. We believe that an in-person visit at the onset of care will
benefit both the clinician's accuracy in administering the elements of
the HCPCS code G3002 bundle of services, and help at the beginning of
care to foster a successful therapeutic relationship between the
clinician and the person with chronic pain. One commenter told us
doctor-patient relationships in pain management have become so
``fraught, mistrustful, and corrosive'' that they have led to a crisis,
as illustrated by CMS' own Journey Map of the Chronic Pain
Experience,\41\ which, in their view, accurately demonstrates the
current ``dysfunctional and damaging state'' of pain care. These
reports support our decision to require that the physician or other
qualified health professional meet with the beneficiary in person for
the first time. We acknowledge that for some people living with chronic
pain who may live far from the clinician's office, or who have issues
with transportation, or whose pain is exacerbated by activity, even
getting to a clinician in-person for a first visit may be challenging.
We are not requiring that each subsequent visit, whether these be
monthly or at some other periodicity be held in-person, but rather
leaving that determination to the discretion and preference of the
clinician and the beneficiary as they are best positioned to together
determine how to develop and maintain the care partnership to
effectively manage pain.
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\41\ https://www.cms.gov/files/document/cms-chronic-pain-journey-map.pdf.
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Comment: A commenter stated that while patients earlier in their
journey managing chronic pain may have care primarily coordinated by a
primary care practitioner, others progressing to high-impact chronic
pain may have their care mainly coordinated via a pain management
specialist; this commenter suggested we allow the codes to be billed at
a maximum twice per month to account for the difference in specialty
primarily managing a patient's care. This commenter also suggested we
add pain management specialists to the list of examples of care that a
patient might need (for example, physical and occupational therapy,
etc.).
Response: We agree with the commenter that it is possible that a
beneficiary living with chronic pain might need to see more than one
clinician type who is enabled to bill for the CPM services--as the
commenter noted, one likely scenario might be a person who sees a
primary care practitioner, and a pain specialist (for the purposes of
this rule, we are not defining ``pain specialist''). As described in
the proposed rule, we believe it is unlikely that most beneficiaries
with pain would want, or need to, see more than a few physicians or
other qualified health professionals in the same month to manage their
pain, and administer the elements of the CPM services for various
reasons, including the reasons commenters who urged us to add the CPM
services to the telehealth list have flagged. We also believe that the
beneficiary would likely object to, or could even by confused by,
having large numbers of clinicians managing their chronic pain.
Although we are not restricting the numbers of clinicians who can bill
HCPCS code G3002, we will be monitoring its use going forward to better
understand more about the types of practitioners and patients using the
CPM codes and services.
Comment: A few commenters requested clarification as to whether the
person being seen for the first time with proposed HCPCS code G3002 had
to have already been diagnosed with a chronic pain diagnosis, or a
condition that causes chronic pain. One commenter stated we should
include both people who both meet the definition of chronic pain on the
first visit, and also people who have adequate medication documentation
or concerns that would likely attest they have met the definition of
chronic pain, to create an equitable care environment.
Response: We are clarifying that the beneficiary, at the first
visit, need not have an established history or diagnosis of chronic
pain, or be diagnosed with a condition that causes or involves chronic
pain; rather, it is the clinician's responsibility to establish,
confirm, or reject a chronic pain and/or pain-related diagnosis when
the beneficiary first presents for care and the clinician is using
HCPCS code G3002.
Comment: Several commenters questioned if clinicians are required
to furnish all appropriate elements of the code bundle in each
encounter for HCPCS code G3002, including medication management. One
commenter stated that we should allow clinicians flexibility for any of
the services listed, in any order and over any time period to best
manage the person's pain condition(s) and that should allow for
omission of certain ones when they are not appropriate or not desired
by the patient (for example, medication management, behavioral
counseling). Another commenter stated that its stakeholders were
concerned that HCPCS code G3002 seems to indicate that all listed
services must be completed to bill for the code.
Response: We are clarifying that clinicians will be required to
furnish all appropriate elements of the code bundle, but also
clarifying that we do not expect that all elements of the code bundle
will be appropriate for every patient. Therefore, we can confirm that
if medication management is appropriate for a specific patient, then a
clinician who bills HCPCS code G3002 will be required to furnish
medication management to that patient. As described later in this
preamble, we will be finalizing the descriptor of HCPCS code G3002 as
follows, with the two modifications shown in italics: Chronic pain
management and treatment, monthly bundle including, diagnosis;
assessment and monitoring; administration of a validated pain rating
scale or tool; the development, implementation, revision, and/or
maintenance of a person-centered care plan that includes strengths,
goals, clinical needs, and desired outcomes; overall treatment
management; facilitation and coordination of any necessary behavioral
health treatment; medication management; pain and health literacy
counseling; any necessary chronic pain related crisis care; and ongoing
communication and care coordination between relevant practitioners
furnishing care, for example, physical therapy and occupational
therapy, complementary and integrative approaches, and community-based
care, as appropriate. We believe that the services enumerated as
examples accurately summarize the
[[Page 69534]]
components of some elements of key care for people with Medicare living
with pain.
Comment: Many commenters requested that we remove medication
management from the code descriptors. One commenter stated it
appreciated medication management being included in the code descriptor
and that careful evaluation of all medications, including use of
American Geriatrics Society Beers Criteria[supreg], should be included
as part of the CPM service, urging us to keep the element of medication
management in the descriptor finalized for this code.
Response: We continue to believe that medication management is an
essential element of pain care, and we are not removing it from the
code descriptors for HCPCS codes G3002 and G3003. A 2022 Congressional
Budget Office publication \42\ indicated nationwide per capita use of
prescription drugs has increased in recent years, as has Medicare Part
D enrollee use, from an average of 48 prescriptions per year in 2009 to
54 prescriptions per year in 2018. In addition, between 2017-2018,
nearly 58 percent of U.S. adults used a dietary supplement \43\ in the
past 30 days, and the percentage of adults using these supplements
increases with age; \44\ nutritional supplements are used by some
people for the treatment of pain.\45\ Although we are not explicitly
defining medication management for the purposes of HCPCS codes G3002
and G3003, we believe that medication management would customarily
include, as part of this element, a review of prescription drugs, over-
the-counter medications, supplements, natural treatments, and/or any
other substances the person with chronic pain might be using for any
purpose. Medicare's Annual Wellness Visit requires the clinician to
collect and document use or exposure to ``medications and supplements,
including calcium and vitamins \46\.'' Common prescription medications
used for pain include acetaminophen, non-steroidal anti-inflammatory
drugs, anticonvulsants, antidepressants, musculoskeletal agents,
antianxiety medications, and opioids. Americans also use dietary
supplements for a range of purposes, including the treatment of
pain.\47\ \48\ Some individuals with pain may also be using substances
such as cannabis and other plant-based treatments for
pain.49 50 Bearing this information in mind, we believe
medication management by the eligible physician or qualified health
professional would be an applicable element of the HCPCS code G3002 for
most beneficiaries with chronic pain.
---------------------------------------------------------------------------
\42\ https://www.cbo.gov/publication/
57772#:~:text=Use%20of%20prescription%20drugs%20among,year%E2%80%94a%
2013%20percent%20increase.
\43\ https://ods.od.nih.gov/factsheets/list-all/.
\44\ https://www.cdc.gov/nchs/products/databriefs/db399.htm#section_3.
\45\ https://www.nccih.nih.gov/health/providers/digest/nutritional-approaches-for-musculoskeletal-pain-and-inflammation.
\46\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
\47\ https://ods.od.nih.gov/.
\48\ https://www.fda.gov/food/dietary-supplements.
\49\ https://www.cdc.gov/marijuana/health-effects/chronic-pain.html.
\50\ https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment/living-review.
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Comment: One commenter stated that massage therapy, therapeutic
exercise programs, and complementary and integrative services (like
acupuncture, tai chi, yoga, and mindfulness meditation) should be
referenced in the code, even if currently not covered by Medicare, and
that clinicians should be allowed to bill for the range of treatments
listed in the HHS PMTF Report, even though the Medicare program may not
pay for those services. One commenter noted that care coordination
could include not just complementary and integrative care, but also
prescribing of durable medical equipment. One commenter stated we
should try to remove barriers to more ``alternative'' therapies.
Response: The PMTF Report recommends a range of treatments and
therapies that could be used for successful pain management including
medications, restorative therapies (for example, therapeutic exercise,
massage therapy), interventional procedures (for example, nerve blocks,
joint injections), behavioral health approaches (for example, cognitive
behavioral therapy), and complementary and integrative health
approaches. The latter include, as described in the Report,
acupuncture, massage and manipulative therapies, mindfulness-based
stress reduction, yoga, tai chi, and spirituality. HHS's 2010 National
Pain Strategy \51\ (NPS) also mentions complementary and integrative
care, focusing mostly on access difficulties for patients with chronic
pain, including insurance coverage. Since the NPS was published,
Medicare has finalized a coverage decision to cover acupuncture for
chronic low back pain.\52\ NIH's National Center for Complementary and
Integrative Health continues to evaluate various approaches,\53\ as is
the cross-cutting NIH HEAL Initiative[supreg] \54\. The HHS Agency for
Healthcare Research and Quality has also performed some work in this
area.\55\
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\51\ https://www.iprcc.nih.gov/sites/default/files/documents/NationalPainStrategy_508C.pdf.
\52\ https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=295.
\53\ https://www.nccih.nih.gov/health/providers/digest/mind-and-body-approaches-for-chronic-pain-science.
\54\ https://heal.nih.gov/funding/awarded.
\55\ https://www.ahrq.gov/topics/complementary-and-alternative-medicine.html.
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First, we are clarifying that we are not requiring in the code
descriptor that a clinician refer a beneficiary to services; that
determination should be made between the clinician and the beneficiary.
We understand that clinicians customarily refer beneficiaries,
including those who have chronic pain, to a range of treatments based
on their individual circumstances, and according to the person-centered
plan of care.
Second, based on the commenter's suggestion and on our proposal
within the CY 2023 PFS proposed rule, where we solicited comment
regarding interest in chronic pain management services and specifically
mentioned specialty care coordination such as complementary and
integrative pain care; recent coverage in Medicare for acupuncture for
chronic low back pain; \56\ and evidence that may point to efficacy for
some individuals with chronic pain using complementary and integrative
approaches, we have elected to revise the code descriptor for HCPCS
code G3003 by adding ``complementary and integrative approaches'' to
the code descriptor as examples of approaches that a clinician could
take in coordinating pain care across a range of treatments and
therapies for a beneficiary. However, we are not requiring that a
clinician make a referral to such care, nor are we requiring that the
clinician only refer Medicare beneficiaries to services currently
covered by Medicare. We are finalizing the addition of ``complementary
and integrative approaches'' to the descriptor for HCPCS code G3003. In
context, the addition will read as follows: ``. . . any necessary
chronic pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.,
physical therapy and occupational therapy, complementary and
integrative approaches, and community-based care, as appropriate.''
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\56\ https://www.medicare.gov/coverage/acupuncture.
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Comment: Several commenters supported the requirement for the
development, implementation, revision, and maintenance of a person-
centered
[[Page 69535]]
care plan that includes strengths, goals, clinical needs, and desired
outcomes by the practitioner furnishing CPM services. A commenter asked
that we recognize the role nurses play in person-centered planning. One
commenter supported this element of the CPM services, and stated that
person-centered care planning is not only key for people living with
chronic pain, but also for others living with serious illness, and that
the person-centered care plan and specifically these elements in the
CPM service should become required for people with serious illness. One
commenter expressed concern that current billing codes compensate
providers the same regardless of the severity of the beneficiary's
condition or time spent with the provider.
Response: We are correcting the code descriptor to more clearly
indicate that we do not expect the clinician to develop, implement,
revise, and maintain the person-centered care plan, that is, performing
each of these activities each time HCPCS codes G3002 or G3003 is
billed; rather, the status of the person-centered plan may vary based
upon the individual circumstances of the beneficiary with chronic pain.
Thus, we are finalizing a revision to the HCPCS code G3002 descriptor
to clarify this element as ``the development, implementation, revision,
and/or maintenance of a person-centered care plan that includes
strengths, goals, clinical needs, and desired outcomes''. We do not
agree, based on the revisions to proposed concurrent billing policies
and revisions in the descriptors that we are finalizing for HCPCS codes
G3002 and G3003, as described above and below, that there will be
insufficient flexibility to address the severity or breadth of needs
that a Medicare beneficiary living with chronic pain might have. We
believe that both the ``and/or'' edit that we are finalizing as part of
the code descriptor, and the additional flexibilities for payment,
discussed below, are sufficient to address the unique needs of each
beneficiary with chronic pain.
Comment: Several commenters opined on the inclusion of pain and
health literacy counseling, which we included as a proposed element of
the HCPCS code G3002 descriptor, to help beneficiaries with chronic
pain make well-informed decisions about their own care, weigh risks and
benefits, make decisions, and take actions that are best for them.\57\
One commenter recommended we instead use the term ``self-care
management,'' and noted that this term is more broadly inclusive of
health literacy counseling. Another commenter stressed the important
role nurses have in ensuring patients are fully informed by educating
and advocating on behalf of patients as they navigate the care
continuum. Another commenter stressed that the receipt of integrative
pain care would involve the practitioner taking into account the
``whole person'' in managing pain, especially important in light of the
importance of care coordination coupled with the goals of health
literacy. (We note that we recently emphasized the importance of health
literacy in our 2022-2032 CMS Framework for Health Equity.\58\) The
Framework's fourth priority is to ``advance language access, health
literacy, and the provision of culturally-tailored services,'' and
states that ``Medicare-enrolled individuals with low health literacy
experience increased hospital admissions and visits to emergency
departments, as well as higher medical costs and lower access to
care.'' Another commenter stated that in their experience, health
literacy counseling is most efficiently done through networks of
chronic pain support groups led by specially trained individuals who
have received training and education by pain leaders, and that it is a
fundamental and essential component in learning to cope with chronic
pain, which is devastating and challenging. The commenter further
observed that we could improve health outcomes by providing funding to
non-profit groups that specialize in chronic pain management to help
grow these type of educational and skill-based support groups. Another
commenter supported this requirement, adding that this should be able
to be provided via telehealth to reduce barriers to entry. A commenter
noted that health literacy, especially with medication adherence, is
valuable to people with chronic pain using multiple medications, as
often these patients lack a comprehensive understanding of all their
medications, which can deter adherence; if they had better resources to
help them understand them, adherence would increase.
---------------------------------------------------------------------------
\57\ https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/health-literacy.
\58\ https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
---------------------------------------------------------------------------
Response: We agree that pain and health literacy counseling is an
important element of care for people with chronic pain and appreciate
the commenters' suggestions about how it can contribute to improved
health outcomes. We thank the commenters, and we are finalizing pain
and health literacy counseling as an element of the HCPCS code G3002
descriptor, as proposed. As we gain experience with the CPM codes we
may consider additional options to increase the availability of pain
and health literacy counseling for Medicare beneficiaries.
Comment: Many commenters opined on our proposal to include
administration of a validated pain assessment rating scale or tool as
an element of code descriptor of HCPCS code G3002. Several commenters
noted that pain subjectivity can make pain management a difficult task,
and that the use of validated pain assessment tools can illuminate and
inform a fuller picture of the person's condition, as well as the
person's care plan. One commenter stated that pain scales can be
beneficial, but they need to be tailored to each person, and that
function and quality of life are also important elements to monitor.
The same commenter recommended the use of the National Quality Forum's
patient-reported measure, Patients' Experience of Receiving Desired
Help for Pain to achieve this. Another commenter stated something
similar, indicating that we should explore ways to address the
inconsistencies in pain measurement due to influences like geography
and cultural norms. Among the many comments related to bias in pain
assessment, one commenter urged us to consider the biases of assessment
tools when proposing a validated pain scale. One commenter vehemently
opposed the inclusion of a validated pain assessment scale citing
concerns with pain bias, proprietary systems, and established outcomes
beyond such scales, which they noted together create a case to avoid
requirements for providers to use scales that have not received
widespread support. The commenter also expressed concerns with pain
bias that has developed over time in pain scales, especially for women,
older adults, and ethnic groups, where the scales were not removed from
use even after bias was documented, potentially worsening health equity
issues. This commenter continued, stating that there is disagreement
over the use of pain scales and that no single scale has been adopted
as a common scale, in part because of proprietary issues. A different
commenter agreed with the assessments of bias in traditionally
marginalized populations, offering that objective pain scales and
objective benchmarked pain data be used. This commenter defined
benchmarked objective pain data including a pain database on adults, a
database on women and pain, an
[[Page 69536]]
orthopedic pain database, or an older adult pain database.
Additionally, we received comments related to the ``well-documented
bias against historically-disadvantaged groups'' in pain assessment,
and suggestions that the best tools for chronic pain also focus on pain
interference, impact on function, activities of daily living, emotional
and psychological health, and the patient's perception of their own
quality of life. Regarding specific tools, one commenter agreed with
administration of a validated pain assessment rating scale or tool, and
stated that we should not limit the acceptable tools; rather we should
enable practitioners to select the most appropriate tool for staff to
administer as part of the person-centered CPM care plan, and that a
reference repository or list of potential tools would be helpful. The
same commenter asked that we not be prescriptive in requiring a
particular scale or tool. Another commenter recommended the
consideration of the use of outcome and quality-of-life measures as
opposed to reductionistic tools that only measure one aspect of pain. A
different commenter supported our proposal to use a validated tool,
suggesting the PROMIS-8A, but urging us to make a list of validated
tools available, and also avoid requiring use of a specific tool.
Another commenter expressed concern about unintended consequences of
using a pain rating scale or tool for validation and suggested the
addition of a measurement that uses objective measures. A commenter
noted that a pain scale is a reliable and valid way to understand the
extent of how pain is impacting the person, but should not be the sole
measure to show improvement. Further, a commenter recommended we
undertake more inquiry before mandating the use of any specific tool or
registry and assemble a stakeholder group, issue a Request for
Information, or use some other means to conduct a landscape analysis of
validated tools. One commenter noted that the use of a validated pain
assessment tool should be excluded and be available as a separate add-
on code. This commenter also noted that such a step would incentivize a
multidimensional assessment of physical, social, and emotional
functioning.
Response: We recognize that periodic assessment of the experience
of pain is an essential element of pain care in the immediate sense and
over time, as chronic pain may be enduring as a symptom of disease or a
long-term disease in and of itself. We also note that no prescribed set
nor single pain assessment measure will be required in the
administration of HCPCS code G3002 or G3003, because no particular tool
or tool set can assess the complex nature of the experience of pain
across all individuals, nor appropriately guide its treatment. We
regularly collaborate with other HHS operating divisions including
working with the National Institutes of Health (NIH) on the NIH
HEAL[supreg] Initiative (Helping to End Addiction Long-term), which
includes more than 30 large scale pain and substance use disorder
programs. The NIH HEAL Initiative and the NIH Pain Consortium pain
research agendas engage nearly all NIH Institutes, Centers, and
Offices. The ambitious and crosscutting nature of the NIH HEAL
Initiative[supreg] and trans-agency interactions of the NIH Pain
Consortium require engagement from experts across disciplines and
sectors and with other HHS operating divisions including CMS. Much of
this NIH research effort focuses on preclinical, translational and
clinical research aimed to improve pain management.\59\ We have been
working with NIH to create and disseminate an accessible, curated, and
dynamic set of Pain Assessment resources for clinicians seeking
instruments to assess their patients' pain and pain-related symptoms
(such as sleep disruption, loss of function, and behavioral health).
The resources are carefully selected as validated and meaningful tools
to inform clinicians and patients in shared decision making as to the
most effective pain management plan for each person. Recognizing that
while many tools are validated in certain populations, they may need
refinement to address cultural sensitivities in populations with health
disparities. We will leverage efforts of the NIH HEAL Initiative to
continue to include appropriately updated tools for these populations
as they evolve. We are finalizing the inclusion of administration of a
validated pain rating scale or tool in the HCPCS code G3002 descriptor.
We will continue to consider opinions and feedback from clinicians and
people with pain as to the use of The Pain Assessment Resource and more
generally, validated screening tools, and collaborate with our NIH
operating division partners to leverage their work in this area and
ensure that the Pain Assessment Resource is comprehensive, inclusive
across disciplines, and up to date over time. A link to the resource is
available at https://www.painconsortium.nih.gov/resource-library/resources-pain-assessment.
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\59\ https://heal.nih.gov/about.
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Comment: We received numerous comments on components of the
proposed CPM services that do not necessarily require a ``face-to-
face'' or in-person visit with the practitioner, such as care that
could be provided by auxiliary staff ``incident to'' the services of
the physician or other qualified health care practitioner. A few
commenters requested clarification on which specific aspects of the
code could be furnished without face-to-face care. We also received
many comments requesting a general supervision requirement, rather than
a direct supervision requirement, with commenters citing provider
shortages as barriers to care. Another commenter suggested that the
initial visit would not have to be face-to-face so long as an in-person
visit occurred shortly after the CPM initiation, and prior to the
prescribing of controlled substance medications for pain. One commenter
stated that other clinical staff in the practice should be able to
follow up and interact with patients. Another commenter stated that
relevant components that could be non-face-to-face could include
questions about medication and improvements related to medication,
social determinants of health, or history of substance use disorders,
or crime, as well as coordination of any necessary behavioral health
treatment, and pain and health literacy counseling. A commenter stated
that most components of the proposed CPM services do not require face-
to-face interaction with the billing practitioner such as overall
treatment management, medication management, pain and health literacy
counseling, and care management which can provided by clinical staff
incident-to a billing practitioner under general supervision, and that
these providers' ability to furnish care has proved to increase access
to medically necessary care, and helped relieve some of the burden for
billing practitioners while still ensuring patients are receiving high-
quality care. A commenter noted that registered nurse care managers
could provide CPM services as incident to services, under the general
supervision of a physician or other qualified health professional.
Another commenter stated that the definition provided of ``provided by
a physician or other qualified health care professional'' was limiting,
and suggested that we use, ``clinical staff time directed by a
physician or other qualified health care professional.'' Another
commenter requested that CMS consider creating separate billing codes
to reflect time spent by physicians and
[[Page 69537]]
clinical staff as is done in the chronic care management (CCM) code.
Response: We agree with the commenters and believe that certain
elements of the proposed bundle, such as care planning or care
coordination with other health care professionals, would not likely
require face-to-face care. These might include activities such as
telephone calls, medical records review, and coordination and
information exchange with other health care providers. We are also not
requiring that subsequent visits for which a physician or other
qualified health professional bills HCPCS code G3002 or G3003 be for
services that were provided to a beneficiary face-to-face. However, the
initial visit for HCPCS code G3002 must be a face-to-face visit.
Comment: A few commenters applauded our efforts to support team-
based care for Medicare beneficiaries with chronic pain. One commenter
stated that chronic pain management may involve arrangements with
psychologists as part of team-based care. Another commenter stated that
since there is no disease-modifying or curative therapy for chronic
pain, best managing chronic pain requires multi-modal interventions and
coordination across a patient's care team, and coordinating care with
other practitioners and providers such as integrative medicine,
physical therapists, psychiatry, and hospital programs.
Response: We agree with the commenters about team-based care, which
leads to better outcomes for beneficiaries, and better experience for
staff, and improves all aspects of care delivery. Team-based care
positively effects the person's care experience, such as office visit
cycle time, care access, preventive screening, self-management, goal
setting and action planning, and medication management. Team-based care
also improves process and workflows, helping to ensure staff are
working at the top of their capabilities, and sharing in
accountability.\60\
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\60\ https://innovation.cms.gov/files/x/tcpi-changepkgmod-nextsteps.pdf.
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Comment: A few commenters requested that the structure of the CPM
codes include payment for the time interdisciplinary providers spend in
consultation with one another. Additionally, this commenter noted
concern that requesting coordination with ``relevant providers'' was
not specific enough, and would not require inclusion of the range of
services available to treat chronic pain. One commenter stated that we
should ensure that reimbursement is revenue neutral, to continue to
encourage practitioners to treat chronic pain.
Response: We are not requiring in the code elements that the
clinician billing CPM codes coordinate and communicate with other
relevant practitioners, as these actions would vary based on the
beneficiary with chronic pain's circumstances. Nor is the list of
services we have used as examples meant to be inclusive of every type
of care a person with chronic pain could require in the course of
individualized treatment for chronic pain. We do expect that
communication and care coordination between providers of all types
would be of benefit to the beneficiary with pain and we leave the
extent of that communication and coordination to the discretion of the
physician or qualified health professional billing the CPM codes, as
appropriate.
Comment: Several commenters requested that we recognize CPM
services for all practitioners who may bill E/M visits, including
oncologists. One commenter noted we had stated the new codes can be
billed by a ``physician or other qualified health care professional''
and agreed that physicians, including primary care physicians, board
certified pain management specialists, neurologists, anesthesiologists,
board-certified headache specialists, rheumatologists, osteopaths, and
other physician specialists that focus on pain conditions should be
able to bill the new CPM codes; the commenter asked us to clarify what
types of practitioners can bill for proposed HCPCS code G3002 and
G3003. A commenter noted that we stated our anticipation that the CPM
codes would most frequently be billed by primary care providers. This
commenter specified that cancer specialists also spend considerable
time managing acute and chronic pain, with this sentiment being echoed
by providers of palliative and hospice care, as well as nurse
anesthetists, all concerned and asking for clarification regarding
whether they ``counted'' as approved providers. A commenter requested
more support and increased access for innovative alternative treatment
to opioids (ALTO) programs, which have been shown in a few states to
reduce opioid prescriptions in emergency department settings. One
commenter stated that, if we identify specialties expected to furnish
the CPM services, geriatrics should be included. Two commenters
recommended that Rural Health Centers and Federally Qualified Health
Centers be allowed separate payment for these codes. One commenter
requested that the code be inclusive of the broad range of providers
that treat pain, as each patient should be able to access the provider
best suited to primarily manage their pain. A commenter stated that,
while we stated we believe primary care providers might most often use
the codes, cancer specialists spend considerable time managing both
acute and chronic pain associated with cancer, and we should explicitly
state that CPM services can be billed by any clinician with E/M
services in their scope, including oncologists and pain management
specialists. Two commenters stated we should make rehabilitation
therapists eligible to bill the code, and, if they are part of the care
team, they should share in the reimbursement proportionally among
practitioners rendering care. One commenter asked that we include
marriage and family therapists as providers who can render CPM
services. A commenter recommended HCPCS code G3002 be billable by other
Medicare providers like doctors of chiropractic. Another commenter
encouraged us to include massage therapists under Medicare Part C in
coding and billing changes to capture services that are provided as
part of complementary and integrative pain care.
Response: We appreciate the commenters' thoughts about the broad
range of provider types that might furnish care that effectively
addresses the many aspects of chronic pain, and note that we are not
limiting the types of physician specialties, or the types of qualified
health professionals, who can furnish CPM services, as long as they can
furnish all of the service elements of HCPCS code G3002, including
prescribing medication as needed, within their scope of practice in the
State in which the services are furnished.
Comment: Several commenters urged us to consider the contributions
of interdisciplinary teams including physical and occupational
therapists, social workers, massage therapists, pharmacists, and
athletic trainers when creating rules for incident to billing. Two
commenters requested that CMS use the term, ``clinical staff'' as is
used in other codes to ensure inclusion of different provider types.
One commenter noted that members of the interdisciplinary team are
needed to provide person-centered, holistic pain management and that
incident to billing will support team-based care, and that we should
consider separate billing for physician time versus other clinical
staff time; another commenter also made this request. A different
commenter noted
[[Page 69538]]
that limitations on ``incident to'' billing has been limiting for the
creation of collaborative, interdisciplinary teams. A commenter asked
us to address ``incident to'' with greater clarity, to explain if the
CPM services could be provided in a domiciliary or home setting, which
is not the same as a provider's office or clinic, including under
general supervision. One commenter noted that component activities of
CPM services can be appropriately provided as ``incident to'' physician
services, as well as by hospital staff under the Medicare Part B
outpatient benefits. The commenter further stated that since staff who
implement CPM care plan services are either office or facility-based,
payment for the services should be recognized under both the PFS and
the Outpatient Hospital Prospective Payment System. One commenter
stated that clinicians such as social workers, pharmacists, and
chaplains could be very helpful to address aspects of chronic pain
through incident to billing. Another commenter recommended CMS focus on
a simpler way to capture and reimburse for CPM services. For example,
CMS might explore whether E/M codes billed with an ICD-10 diagnosis
code for chronic pain from the G89.xx series, in which a person-
centered plan of care for pain is documented, could be eligible for
monthly billing of a G3003-type code (for example, each 15 minutes of
CPM care plan services implementing an individualized CPM plan
inclusive of staff monitoring patient's adherence and response to the
plan, coordinating services and communicating with other practitioners
and providers). This G3003-type code would acknowledge and pay for the
component activities of CPM care plan services that are appropriately
provided ``incident to'' physician services by practitioner-employed
office staff or by hospital staff under the outpatient hospital
benefits.
Response: We note that this rule generally addresses payment for
physicians' services under the PFS. Comments regarding other payment
systems not addressed in the proposed rule are outside the scope of
this rulemaking. The billing practitioner should report the place of
service for the location where they would ordinarily provide face-to-
face chronic pain management services to the beneficiary. We thank
commenters for their feedback and may consider further development of
the CPM codes to recognize components that could be furnished by
auxiliary personnel incident to the services of the billing
practitioner, and components that could be primarily performed by
clinical staff, in the future. We note that auxiliary personnel is
defined at Sec. 410.26(a)(1) as any individual who is acting under the
supervision of a physician (or other practitioner), regardless of
whether the individual is an employee, leased employee, or independent
contractor of the physician (or other practitioner) or of the same
entity that employs or contracts with the physician (or other
practitioner), has not been excluded from the Medicare, Medicaid, and
all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in which the services are
being furnished. We did not propose to change this definition of
auxiliary personnel in the proposed rule, and therefore, the comments
asking CMS to modify the definition of auxiliary services are outside
the scope of this rulemaking. Additionally, we note that all
requirements for services furnished incident to a physician's (or
practitioner's) professional services listed at Sec. 410.26 continue
to apply. We will keep the commenters' concerns in mind when
considering any further development of the CPM codes in the future.
Comment: Many commenters asked us to clarify if the proposed CPM
services would be available for billing/reporting in conjunction with
remote patient monitoring (CPT code 99091), remote physiologic
monitoring (CPT codes 99453, 99454, 9457, 99458), or remote therapeutic
monitoring (CPT codes 98975, 98976, 98977, 98980, 98981 and as proposed
GRTM1/2/3/4 codes. One commenter also requested clarification
surrounding what virtual presence/remote supervision is permitted, who
can order these services, what documentation is required, and whether
billing is permitted for individual services in addition to the
management components of CPM. A commenter noted that patients with
chronic pain may also benefit from remote therapy monitoring to monitor
their pain levels, medication adherence, and response to prescribed
therapy regimens.
Response: HCPCS codes G3002 and G3003, and the services describing
remote patient monitoring, remote physiologic monitoring, and remote
therapeutic monitoring, are distinct types of services, although there
may be some overlap in eligible patient populations. There may be some
circumstances where it is reasonable and necessary to provide both
services in a given month. Thus, HCPCS codes G3002 and G3003, could be
billed for the same patient in the same month as the Remote Physiologic
Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) services. All
applicable requirements for the individual codes must be met, per the
elements of each individual code, for both types of remote monitoring
and CPM services. Additionally, the time and effort cannot be counted
more than once when billing CPM codes concurrently with RPM or RTM.
Billing practitioners should remember that cost sharing applies to each
service independently. If all requirements to report each service are
met, without time or effort being counted more than once, then CPM and
RPM or RTM may be billed.
Comment: Several commenters stated they were concerned about low
payment, and other payment issues related to the proposed CPM codes,
which we had valued in our proposal based on our conclusion that the
CPM services were similar in work (time and intensity) to that of
Principal Care Management (PCM) service. One commenter observed that in
order for physicians to be willing to treat chronic pain patients,
especially primary care physicians, we need to make physician payments
for the new CPM codes higher than primary care and PCM visits to avoid
lower payment for CPM than for a standard follow-up clinical visit for
primary care (CPT code 99214 for 30 min clinical visit). The commenter
was very concerned that unless we considered raising these rates before
the new CPM codes go into effect, physicians will not use them to
accomplish the intended improvements in pain care that Medicare
patients so desperately need, and that the use of other codes not
specific to pain will impair our ability to accurately track data
regarding chronic pain, and care outcomes, in the Medicare program.
Another commenter had similar concerns, recommending that the valuation
of the new codes be on par with current office and outpatient E/M
codes. A different commenter noted that it had significant concerns
with our proposal to disallow use of the codes on the same day as a
``general'' visit like an E/M visit where the person is being seen for
a separate illness or condition, and that this would be a grave mistake
that would hamper the delivery of truly integrative pain care. This
commenter also added that this move would exacerbate disparities at a
time when CMS is working to promote health
[[Page 69539]]
equity, urging us to allow same day E/M billing. Another commenter
requested clarification regarding the interaction with other service
codes to ensure that this code enhances rather than inhibits physician
encounters. A different commenter stated that people living with
chronic pain are likely to have at least one or more comorbidities that
are being treated along with their pain, and often these health
concerns are, in fact, addressed by one singular practitioner on the
same day. The same commenter noted that requiring people to be seen on
different days that they come for other health care services will
significantly reduce numbers of people with pain who are willing, or
able, to receive CPM services, including people who are older adults,
disabled, homeless, lack reliable/affordable transportation, cannot
take time off work, and/or are unable to secure child care--among other
issues. The commenter stated mandating repeated in-person visits would
be arduous for disabled people already poorly served by public
transportation, a problem that characterizes many smaller cities,
suburbs, and rural communities. Another commenter stated that our
proposed code valuation will prohibit use of the codes or make them go
unused, as they pay less than CPT code 99214, or result in less
payment, causing providers to reconsider the number of pain patients
they care for. Additionally, the commenter expressed fears that for
providers already wary of rendering care to people with chronic pain,
the valuation of the codes would further disincentivize them from
treating these patients, not only paying less, but requiring more work.
The commenter described a ``worst case'' scenario where if the codes
became ``required'' for people receiving CPM services (for example, use
of a 99xxx code was deemed fraudulent) it anticipated that many
clinicians would cease seeing patients with chronic pain because of the
low valuation, and required services that appear ``extraordinarily
laborious.'' This commenter included several real life scenarios from
clinicians working at the front lines of pain; stating that if we
really wish to support the use of CPM, the valuation should be at least
(emphasis added) comparable to CPT code 99213 or 99214, but to truly
incentivize (emphasis added) adoption and utilization of CPM services,
we should consider significantly increased reimbursement to allow CPM
services to grow sufficiently to meet anticipated demand. A different
commenter noted primary care providers will be disinclined to prescribe
opioids due to this payment rule. The commenter expressed concern that
these patients will then have to find pain management clinics, which
are not present in all communities. A commenter stated a similar
opinion, discussing that primary care providers are afraid of
prescribing opioids and that patients are suffering as a result.
Another commenter noted that they would like the code to differentiate
between a patient who is now meeting the threshold for chronic pain
from those patients with a previous diagnosis of chronic pain, who is
simply seeing a new provider. This commenter noted that a person is an
expert in their own condition, and sharing all of that information with
a new provider is often very time-consuming, whereas someone with new
chronic pain may not have as much information to share. This commenter
recommended ``substantial'' time for both scenarios. One commenter
requested clarity on the interaction between the E/M and CPM codes to
avoid any inadvertent misuse by providers, and recommended that CMS
consider creating a modifier to attach to the CPM codes to prevent
double payments. Another commenter was concerned that the proposed CPM
codes could lead to an underutilization of important non-opioid pain
management options because providers are not clear on the rules around
the use of these codes. One commenter opined that there should not be
any concurrent billing restrictions imposed on CPM services, which
would force patients to pick between certain services and care. Another
commenter noted that the current valuation and payment are
disproportionate to the work required of HCPCS code G3002, and noted
that this code more closely aligns with what is included in a level 4
or 5 E/M service. A different commenter echoed previous statements
regarding concern that the valuation of HCPCS codes G3002 (formerly
GYYY1) and G3003 (formerly GYYY2) and RVUs will create disincentives to
care for patients with chronic pain. The commenter suggested separating
HCPCS code G3002 into two codes: one code for face-to-face that is
valued higher than a standard E/M visit, and a second for coordination
undertaken by the physician or other qualified healthcare professional
outside of face-to-face care (similar to CCM and PCM codes). Another
commenter suggested two add-on codes for HCPCS code G3003 because these
patients can be complex, and may require intense coordination. An
additional commenter suggested adding a GYYY3 and GYYY4 code. HCPCS
code G3002 (formerly GYYY1) would remain and HCPCS code G3003 (formerly
GYYY2) would be half the resource inputs of G3002. GYYY3 would be a new
code for subsequent visits after the initial visit with a 15-minute
threshold instead of a 30-minute threshold, and GYYY4 would be another
new code for administration of the validated pain measurement as an
add-on for HCPCS codes G3002 or G3003. One commenter stated that the
code should be treated as an E/M and fall into the category as a visit,
billed in FFS clinics and related to RHCs and FQHCs paid for as per the
current methodology. The commentator suggested using a payment
``crosswalk'' of 99213 and 99214 tied to proposed HCPCS codes G3002 and
G3003, including a modifier of 30-40 percent to compensate providers
adequately for the labor involved in CPM services. One commenter stated
that it believed clinicians billing for CPM services would face
substantial decreases in work RVUs generated relative to current
reimbursement compared to outpatient E/M codes and is unclear on how
both codes could be billed. Another commenter stated that they believed
the reimbursement proposed is inappropriately low, and urged us to
adjust the proposed RVUs of 1.45 for HCPCS code G3002 and 0.5 for HCPCS
code G3003 in the final rule. This commenter noted the work intended in
this code will require significant time investment by physicians,
qualified health professionals, and clinical staff. The same commenter
noted HCPCS code G3002 should be crosswalked with CPT code 99414 at
1.92 work RVUs and HCPCS code G3003 be crosswalked with CPT code 99212
at 0.7 work RVUs. Another commenter stated we are undervaluing HCPCS
code G3002 by crosswalking it to CPT code 99424, which has 1.45 RVUs. A
similar 30-minute new patient office visit (CPT code 99203) is valued
at 1.6 RVUs. This commenter also stated that an established patient
visit (CPT code 99214) is valued at 1.92 RVUs. This commenter
recommended CPT codes 99495 and 99496 for better crosswalks. Another
commenter requested clarification on whether it is permissible for the
same practitioner to bill a service like interventional pain management
during the same month the clinician bills for the CPM services. Another
commenter noted that E/M codes 99214 and 99213 already allow for time-
based, face to face encounters with providers, have similar or greater
work RVUs, and less limitations and requirements as compared to those
specified in the code
[[Page 69540]]
descriptors for G3002 and G3003. This commenter recommends increasing
the time allotment to 45 and 20 minutes for HCPCS codes G3002 and
G3003, respectfully. The same commenter also expressed concern that
providers would be less likely to utilize the CPM codes in favor of
those they are already using and allowing for an increase in time
allotment would correct this issue, according to this commenter.
Response: It is not our intent to either underpay, or create
incentives for clinicians to use other codes that would constrain the
use of the new codes. However, in the absence of experience with these
new codes, we must base our projections reasonably on our experience
with existing codes that we believe bear some relationship to the new
proposed codes, such as the PCM code. Therefore, in light of the
crosswalk to CPT codes 99424 and 99425, we are finalizing as proposed
the work RVUs of 1.45 for HCPCS code G3002 and 0.5 for HCPCS code
G3003. We will monitor use of the CPM codes to better determine if the
payment rates and billing flexibilities are appropriate. In the
proposed rule, we outlined our concerns about duplicate, or overlap
billing in situations where the eligible clinician might bill certain
E/M codes on the same day the CPM service(s) are rendered. Based on the
commenters' concerns, we have reconsidered our approach to billing CPM
services. We believe that, due to the complexities of pain treatment,
there could be beneficiaries seeing a clinician for the first time, or
in a subsequent visit, who could also need to be seen by the clinician
for the CPM service(s) on the same day, or for a subsequent visit. The
code sets for E/M services are organized into various categories and
levels; the more complex the visit, the higher level of the code the
clinician would bill within the appropriate category. Clinicians must
make certain that the codes selected are appropriate for the services
furnished, and that they fulfill the requirements to bill an E/M
service.\61\ Many Medicare beneficiaries have multiple chronic
conditions,\62\ and many of these conditions could involve chronic
pain. We believe it is reasonable to assume that in many instances, the
clinician could be spending time with the Medicare patient discussing
health and wellness related to a variety of conditions that person may
be experiencing, or expect to experience, and that interaction might
not have a focus on the chronic pain aspects of the person's care.
Additionally, if the person with pain has made the effort--which could
be considerable, as commenters have noted, to get to an appointment
with a clinician, it makes sense from a burden standpoint--allowing for
the burden on both the clinician, and the person with Medicare, to
permit billing for both the E/M service, and the CPM service(s) on the
same day. Therefore, if all requirements to report each service are
met, without time or effort being counted more than once, then both E/M
and CPM may be billed on the same day.
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\61\ https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/eval-mgmt-serv-guide-icn006764.pdf.
\62\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Chartbook_Charts.
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Comment: Two commenters requested that we revisit existing guidance
and regulations to allow pharmacies to bill Medicare for opioid-based
compounded drugs. Another commenter urged CMS to reconsider the issue
of reimbursement for medication used in intrathecal pumps. One of these
commenters also requested that the compounded medications delivered to
the physician's office for insertion into an implanted pump be
reimbursed as an incident-to drug or Durable Medical Equipment,
depending on the billing entity.
Response: We appreciate the commenters' thoughts about compounded
drugs and reimbursement for medication used in intrathecal pumps;
however, these comments are out of the scope of our proposals for CPM
services.
Comment: Many commenters asked us to add CPM services to the
Medicare Telehealth Services List. One commenter asked that we enable
the CPM codes, in addition to being rendered through telehealth, to be
furnished through audio-only technology. We address these comments in
section II.D.1.c. of this final rule, Other Services Proposed for
Addition to the Medicare Telehealth Services List.
Comment: One commenter suggested we include screening services in
the CPM bundle to identify, reduce, and prevent hazardous or harmful
alcohol and drug use, which the commenter characterized as common in
people with SUD in residential treatment settings living with chronic
pain. An additional commenter echoed the request for screening to
identify, reduce, and prevent hazardous or harmful alcohol and drug use
generally. This commenter also encouraged the inclusion of ordering of
tests and Durable Medical Equipment, as well as consultations with
other providers and communication with pharmacies be included. One
commenter suggested the inclusion of nutrition screening and nutrition
therapy in the code descriptions, as people with chronic pain often
have complex dietetic and nutritional needs. Another provider group
recommended that the term ``prognosis'' be added to the ``diagnosis''
in the bundle description as an option.
Response: As outlined in the proposed rule and in the CPM code
descriptors, we expect clinicians to facilitate and coordinate any
necessary behavioral health treatment, and other relevant care
associated with HCPCS codes G3002 and G3003, such as complementary and
integrative approaches and/or community-based care. This includes, as
described in the CMS Behavioral Health Strategy,\63\ multiple elements
including access to prevention and treatment services for SUD, mental
health services, crisis intervention and pain care to enable care that
is well-coordinated and effectively integrated. Under the Strategy, we
have defined behavioral health as ``encompassing a beneficiary's whole
emotional and mental well-being, which includes, but is not limited to,
the prevention and treatment of mental disorders and substance use
disorders.'' ``Whole-person care'' is defined as ``the whole of a
beneficiary's needs including physical health, behavioral health, long-
term services and supports (home and community-based services, and
institutional care), and health-related social needs.''
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\63\ cms.gov/cms-behavioral-health-strategy.
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Comment: One commenter suggested we ensure that the proposed CPM
codes are reimbursable in the beneficiary's home, and all other
settings where primary care, mental health care, and SUD care can
occur. Another commenter recommended inclusion of residential treatment
facilities, long term care facilities, and homes as settings in which
billing can occur.
Response: We appreciate the commenter's suggestion that we ensure
that the proposed CPM codes are payable for services delivered in the
beneficiary's home, and all other settings where primary care, mental
health care, and SUD care can occur. We note that CPM is priced in both
facility and non-facility settings, and we are not limiting the place
of service for CPM, other than as discussed above (the initial visit
must be in-person). The billing practitioner should report the place of
service for the location where they would ordinarily provide face-to-
face chronic pain management services to the beneficiary
Comment: Several commenters stated that the elements of the
proposed CPM codes favor prescriptions by medical
[[Page 69541]]
providers, instead of prioritizing non-pharmacological strategies for
pain management, including those developed by psychologists, that may
be safe and effective for many patients. One commenter further stated
that the creation of additional bundled codes that do not include
medication management will allow for greater flexibility in treatment
and allow psychologists to provide pain management services and
practice to the top of their license when participating in team-based
comprehensive chronic pain treatment. Another commenter suggested that
physical and occupational therapists should be able to bill the codes,
stating that these practitioners' practice integrates an understanding
of a patient's or client's prescription and non-prescription regimen
with consideration of its impact on health, function, movement, and
disability, and that it is within the physical therapist's professional
scope of practice to administer and store medication to facilitate
outcomes of physical therapist patient and client management. The same
commenter asked that we require, in the code descriptor, that
physicians and other non-physician practitioners must refer appropriate
chronic pain patients to physical and/or occupational therapy prior to
being reimbursed for the codes. A few commenters requested that CMS
create a code for providers who do not bill for E/M codes. One
commenter stated that physical therapists and psychologists are not
qualified to perform all the necessary services we have outlined, such
as thorough pain assessments and diagnoses, medication management,
crisis care, etc. and suggested we establish a path whereby non-
physician professionals can bill a chronic pain code for services that
are part of an overall treatment plan. Two commenters suggested that
education be provided to physician providers to increase the
consultation of physical and occupational therapists, also stating that
physical therapists are significantly underutilized in community and
rural settings.
Response: We acknowledge and support the important work of
psychologists and occupational and physical therapists in the care of
people with Medicare, including beneficiaries with chronic pain. We
believe that this code describes a distinct PFS service that is
reasonable and necessary in the diagnosis and treatment of the person
with chronic pain, and that medication management, as described in the
preamble text above, is a key element of such care and of the proposed
HCPCS code G3002; therefore, we are including it as a code element.
We understand that cognitive behavior therapy (CBT), as one
example, is a common treatment provided by psychologists, including to
people with chronic pain.64 65 66 Medicare covers
psychotherapy, as well as other services that support mental health and
wellness.\67\ Chronic pain can be linked, in some people, to mental
health conditions, such as anxiety and depression.\68\ Psychotherapy is
billed with Current Procedural Terminology (CPT) codes \69\ that
reflect the amount of time spent with the patient, and family may or
may not be present during these therapy sessions. To bill these CPT
codes, the psychotherapist must provide a mental health diagnosis using
an International Classification of Diseases (ICD) code and/or
Diagnostic and Statistical Manual (DSM) code.
---------------------------------------------------------------------------
\64\ https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.
\65\ https://www.va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf.
\66\ https://www.nih.gov/news-events/nih-research-matters/meditation-cognitive-behavioral-therapy-ease-low-back-pain.
\67\ https://www.cms.gov/files/document/mln1986542-medicare-mental-health.pdf.
\68\ https://health.gov/healthypeople/objectives-and-data/browse-objectives/chronic-pain.
\69\ https://www.ama-assn.org/practice-management/cpt.
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While clinical psychologists (CPs) do not have prescription
authority in all States and are therefore, not authorized to bill the
Medicare program for any of the CPT codes that include medication
management components, there are CPT codes that CPs can bill for
treating Medicare patients who are diagnosed with chronic pain. Hence,
the Health and Behavior Assessment and Intervention (HBAI) range of CPT
codes are intended to be used for psychological assessment and
treatment, when the primary diagnosis is a medical condition, such as
chronic pain.
This family of codes was revised in 2020, when a new set of codes
to describe these HBAI treatment services went into effect.\70\ Health
behavior assessment under these HBAI services is conducted through
health-focused clinical interviews, behavioral observation and clinical
decision-making and includes evaluation of the person's responses to
disease, illness or injury, outlook, coping strategies, motivation and
adherence to medical treatment. Health behavior interventions under
these HBAI services are provided individually, to a group (two or more
patients), and/or to the family, with or without the patient present,
and include promotion of functional improvement, minimization of
psychological and/or psychosocial barriers to recovery, and management
of and improved coping with medical conditions. The HBAI codes apply to
services that address psychological, behavioral, emotional, cognitive,
and interpersonal factors in the treatment/management of people
diagnosed with physical health issues. Use of HBAI codes requires a
physical health diagnosis (ICD-10) to be the primary diagnosis. The
HBAI codes capture services related to physical health, such as
adherence to medical treatment, symptom management, health-promoting
behaviors, health-related risky behaviors, and adjustment to physical
illness. The HBAI codes and the Psychotherapy codes cannot be billed
contemporaneously. We believe HBAI codes are well-suited to the
provision of CBT, as appropriate, to people with chronic pain when the
person does not have a concurrent mental disorder.
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\70\ https://www.apaservices.org/practice/reimbursement/health-codes/health-behavior.
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For HCPCS codes G3002 and G3003, we are finalizing the codes for
use by physicians and other qualified health professionals. However, we
will consider if there is a benefit to modifying these codes and/or
creating new codes that can potentially support broader chronic pain
management by other practitioner types, including those who may not be
prescribers in the scope of practice in the State in which they
practice and are an important part of the care team for beneficiaries
with chronic pain, in future rulemaking, such as clinical
psychologists, or doctors of chiropractic. We do not agree that
clinicians should be required to make referrals to occupational and
physical therapists; although, as we stated in the proposed rule, and
in the code descriptor, we do expect that there will be ``ongoing
communication and care coordination between relevant practitioners
furnishing care, for example physical therapy and occupational therapy
. . . as appropriate.''
Comment: Several commenters opined on our proposal to require
verbal consent at the initiating visit, or at the initiating visit and
subsequent visits, to help make sure that people with Medicare living
with chronic pain want the services, are aware they may need them, and
that they also receive an explanation of any cost sharing that may
apply in their particular situation. All commenters were supportive of
our proposal. One commenter stated that, although it supported
requiring consent, it noted that consent should be obtained at the
third visit, so patients could be given an opportunity to work with the
[[Page 69542]]
physician a few times, but at the first visit the physician should
still be required to educate patients regarding CPM services, explain
their frequency/purpose/value, and any cost-sharing that may apply, so
patients can better understand the model which is different according
to the commenter from the disjointed, fragmented, solitary struggle for
effective pain care that the vast majority of pain patients presently
experience, and that in this manner, patients would have an opportunity
to understand CPM services better. The commenter also stated consent
should be discussed, including any costs with family/unpaid caregivers.
The same commenter stated we need not require consent at each visit,
and suggested that we should support practitioners referred by the CPM
billing practitioner to also seek the patient's consent, to emphasize
in part that they are working as a team. A different commenter stated
that in implementing the new codes, we should establish requirements
similar to CCM services, for example, requiring that providers document
that all components of the service are met and that informed consent,
inclusive of cost-sharing, has been obtained. Another commenter urged
us to allow consent to be obtained and documented by members of the
care team in addition to the physician/qualified health profession. One
commenter believes that verbal consent should be obtained upon
enrollment (at the first visit) and not at every visit, which would
create inefficiencies. The spouse of a person living with longtime
chronic pain observed that ``patient consent, consultation should
always be a part of primary care as patients are typically ignored,
especially in pain management.'' A commenter stated that consent, for
some people with dementia or other cognitive health issues, might have
to be obtained through a legal representative outside of the face to
face initiating visit.
Response: We are appreciative of the comments regarding consent, as
we believe the person with chronic pain should be educated regarding
what the CPM services are, how often they may be generally expected to
receive the services at this initial visit, and receive an explanation
of any cost sharing that may apply in their particular situation; this
is an important element of person-centered care and self-determination.
We disagree with the commenter who suggested we obtain verbal consent
after the first visit. Similar to how the Medicare Chronic Care
Management service is administered, we believe the physician or
qualified health care practitioner should get the person's consent for
services before the practitioner bills for them. This helps to ensure
that beneficiaries are engaged and are aware of their treatment and
cost sharing responsibilities, and helps prevent duplicate billing. If
the beneficiary does not provide consent or if other conditions for
payment are not met, the practitioner cannot bill Medicare. As outlined
in this preamble, referrals may be made to providers who are not
rendering a Medicare covered service(s), or who may not be enrolled in
Medicare, such as acupuncturists, massage therapists, psychiatrists,
dieticians, dentists, and providers of community-based services, which
could include companies that make environmental modifications, adult
day health programs, direct support workers, and others, and we do not
believe that requiring consent from providers who are not billing for
the CPM codes is necessary or practicable. We agree that providers
should document in the record that the beneficiary has given consent
for the services, although we are not requiring that the clinician
document that ``each element'' of the code has been delivered, since
that would vary based upon the person's needs. We are thankful for the
commenter who noted that consent, for some beneficiaries, may have to
be obtained from a legally responsible person, such as for people with
chronic pain who have dementia, an intellectual or developmental
disability, or any other type of cognitive disorder; those arrangements
vary under State law.
Comment: One commenter recommended that we focus and support
continued communication and care coordination for the CPM services,
which it stated has been a long-time struggle for chronic pain care,
but an essential element, especially in underserved communities.
Response: We agree that care coordination and communication between
all clinicians and other providers furnishing care to beneficiaries
living with chronic pain is an essential element, including for people
with pain living in underserved communities.
Comment: A few commenters stated that payers and providers should
look at quality care and meaningful improvements in function and
quality of life (beyond use of a validated pain rating scale or tool).
One commenter stressed the importance of utilization and outcome
measures that can assess efficacy and cost-effectiveness such as
hospitalizations, emergency department and urgent care visits,
specialist utilization and procedures, number of prescription
medications, and other health care data. Another appreciated our
interest in growing the available data related to the prevalence and
impact of chronic pain in the Medicare population, and requested that
once we collect data, this data be deidentified and made available to
the public to assist interested parties in the development and
refinement of programs. Another commenter requested that we provide a
mechanism for quality outcomes measurement based on the provided
service to shed light on pain experienced by the Medicare population,
what works best, and what provides improved health outcomes, in part to
reduce the need for specialty care and hospitalization. One commenter
noted the importance of medication adherence, and data regarding
medication adherence specific to chronic pain, including to avoid
unnecessary hospitalizations, adverse events, and deaths.
Response: We agree with the commenters that quality and data
collection are foundational components to delivering value as part of
the overall care journey, and help ensure optimal care and best
outcomes for people of all ages and backgrounds, and across service
delivery systems/settings, and payer types, as described in our CMS
National Quality Strategy.\71\ We are aware that there are scant
measures that examine chronic pain and medication adherence for chronic
pain, and trust that government and interested parties will continue to
explore options in measure development, testing, and endorsement to
improve measurement in chronic pain care. However, because we did not
make any proposals regarding the link between quality and CPM codes,
these comments are out of the scope of our proposed rule.
---------------------------------------------------------------------------
\71\ https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality.
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Comment: Several commenters wanted to ensure that use of the CPM
codes would not limit or interfere with the beneficiary's access to
other medical or pharmacy benefits.
Response: We appreciate the comment and can confirm that its use
will not interfere with other medically necessary Medicare benefits.
Comment: Many commenters requested more specifics related to the
administrative requirements and potential burdens the use of the CPM
codes would place on providers. Commenters urged CMS to work to ensure
the documentation requirements not be overly burdensome. This was
echoed by a commenter with chronic
[[Page 69543]]
pain who noted that physicians seem ``overwhelmed with today's
paperwork and administrative demands.''
Response: In 2020, we established our Office of Burden Reduction
and Health Informatics,\72\ to unify our efforts to reduce regulatory
and administrative burden, and advance interoperability and national
standards. We are continuing to engage beneficiaries and the clinical
community to better understand their experiences, form solutions, and
infuse CMS with a customer-focused mindset. We will be interested to
get feedback from clinicians about burden, once the CPM codes are
implemented in practice.
---------------------------------------------------------------------------
\72\ https://www.cms.gov/About-CMS/OBRHI.
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Comment: A few commenters recommended CMS reduce potentially
prohibitive payment methods, including prior authorization and cost
sharing to improve access to chronic pain management. These commenters
also suggested increasing access for non-opioid methods of pain
management, such as physical therapy and behavioral health care.
Another commenter also requested further clarification of cost sharing
requirements, as many people with chronic pain have disabilities, with
concern about limited access to pain management.
Response: The various interventions described in the PMTF Report's
pain management ``Toolbox'' attest that individualized care consists of
diagnostic evaluation that results in an integrative, person-centered
care plan that includes all necessary treatment options, that we hope
clinicians will consider when they treat Medicare beneficiaries with
chronic pain. Regarding cost-sharing, as described above, standard Part
B cost-sharing will apply to the CPM services. In some instances,
people who are low income or disabled and are dually eligible Medicare
and Medicaid beneficiaries, for example, will have different cost-
sharing from beneficiaries who are enrolled in Medicare, only. We
emphasize that the CPM codes do not require prior authorization.
Comment: One commenter expressed concern and confusion over our use
of the word ``bundle'' in the proposed rule, which they interpreted as
payment that contemplated paying other involved providers in an episode
of care environment. The commenter further stated that payment-based
``bundling'' is already a fast-growing and promising form of pain care
that should be correctly labeled.
Response: We apologize for any confusion by our use of the word
``bundle.'' The proposed CPM codes are not bundles as the commenter
contemplates, but rather codes similar to the CCM codes, or the code
for Cognitive Assessment and Care Planning Services, 99483, that denote
the elements of the code itself. By ``bundle,'' we were just referring
to all of the elements contained within the CPM code descriptors.
Comment: One commenter stated that caregivers and trusted family
members are also part of the team providing support to people with
chronic pain, and recommended including these individuals in the CPM
services, which it noted is especially important for people who have
communication or cognitive issues. Another commenter stated that
caregiver participation for these individuals is especially important
as they are often directly affected by the person's pain and can help
in making its perception better, or worse.
Response: We agree that the role of caregivers is of critical
importance across Medicare as caregivers provide a broad range of
mostly unpaid assistance with diverse health-related activities
provided by a friend, family member, partner, or neighbor to a care
recipient. The caregiver has a significant personal relationship with
the care recipient, and care may be episodic, daily, occasional, or of
short or long duration. Caregivers assist in basic personal care
activities such as eating and bathing; household management activities,
such as shopping and meal preparation; and other activities, such as
managing medications, attending medical encounters, and coordinating
financial and other activities, such as handling insurance and paying
bills. Caregivers may also be involved in managing complex health care
and assistive technology activities at home and in navigating care
transitions between settings of care. We are pointing out that Medicare
makes payment for CPT code 96161 (Administration of caregiver-focused
health risk assessment instrument (e.g., depression inventory) for the
benefit of the patient, with scoring and documentation, per
standardized instrument). However, as noted in the descriptors for
HCPCS codes G3002 and G3003, CPM services must be furnished by a
physician or other qualified health practitioner.
Comment: One commenter stated that in implementing the CPM
services, it is important for CMS to take a balanced approach between
administrative burden and program integrity, and that use of the codes
should be considered along with potential risk of ``bad actors'' to
inappropriately use them. The same commenter indicated that we should
prevent multiple group practices from concurrently billing for this
service for the same patient during the same time period as this would
eliminate duplicative services and payment. A different commenter
echoed that sentiment, concerned with ``doctor shopping,'' leading to
billing denials and driving up provider costs. Another commenter viewed
this problem differently, discussing that some patients will travel for
answers, or based on the availability of chronic pain providers in
their areas, may need to see their primary care provider first, then
may see other providers. This commenter was concerned that providers
would not specifically know when this code was billed by previous
providers, risking rejection even after services were provided. This
commenter recommended eliminating the limits on monthly billing.
Response: As with implementation of any new billing code, we will
be monitoring its use going forward, not just for data and other
purposes, but also for program integrity reasons. For HCPCS code G3002
and G3003, we would not generally expect multiple group practices to be
concurrently billing for a service that is to be rendered once per
month, per practitioner, per beneficiary. As noted previously, we will
be gathering data on the clinicians billing for and patients receiving
the services described by these CPM codes, and we may consider making
changes to these codes in future rulemaking, if necessary.
Comment: One commenter asked us to consider whether or not our
proposal to create new codes for CPM is the best course, or if we
should reconsider and expand the CCM codes. Another commenter
elaborated on issues with the CCM codes, stating these are confusing to
clinicians, involve administrative and documentation burden, which
discourages uptake, and that it hopes this scenario will not develop
with the CPM codes.
Response: We appreciate the comments about CCM vs. CPM; we did
consider differences in the CCM codes, which we explained in the
proposed rule, and believe the best course is to finalize the CPM codes
and monitor their use in practice.
Comment: One commenter stated that evidence shows that many people
with chronic pain, especially people from communities of color, have
low trust in the health care system, based on previous discrimination
and follow up. Another commenter stated that it is very important we
improve pain management for members of racial and ethnic minorities,
given both the rising
[[Page 69544]]
rates of drug overdose deaths among these populations and disparities
in the identification and effective management of pain.
Response: As we outlined in the proposed rule, we are aware of
disparities in chronic pain care and seek to address these disparities
in part through finalization of the CPM codes.
Comment: A commenter asked that we consider a ``MedLearn'' article
or Educational Transmittal to help providers understand more about the
CPM services including who can bill, documentation, potential
restrictions with other codes, etc. Several other commenters suggested
provider communication such as a Medicare Learning Network article or
similar blog post to summarize comments and the final rule. Another
commenter suggested that we convene all essential stakeholders in
public meetings, organized by the Agency, to hear stakeholder input
about the best way to move forward to encourage rather than limit non-
opioid pain management.
Response: We appreciate these suggestions from the commenters and
are considering how best we can educate providers about use of the new
codes, working with our HHS operating division partners.
Comment: A few commenters stated that CPM services should be able
to be billed concurrently with CCM, Behavioral Health Integration, or
Primary Care Management. Another commenter noted that CPM services
might disincentivize the provision of CPM services to the most complex
patients in part because neurologists routinely bill certain codes for
safety purposes, and the CPM proposal, which prohibited same day
billing of certain other codes, would impair care.
Response: We thank the commenters for sharing their feedback. As
noted in the CY 2023 PFS proposed rule, we believe there are
distinctions in the nature and extent of the assessments, care
coordination, medication management, and care planning for CPM to allow
concurrent billing for services that are medically reasonable and
necessary, and that it is particularly important to allow for the
provision of needed services, including behavioral health services to
beneficiaries with chronic pain. Therefore, if all requirements to
report each service are met then CPM may be billed in the same month as
CCM, TCM, and BHI services. We reiterate that the time spent in
providing CPM services may not represent time spent in providing any
other reported service.
Comment: A commenter questioned how the CPM codes relate to the
proposal in the CY 2023 OPPS proposed rule that would add the Facet
Joint Interventions service category to the prior authorization list.
This commenter noted that it seems incongruous for CMS to be
encouraging chronic pain management with this CPM code while
discouraging it in another.
Response: We thank the commenter for the comment; however, the
discussion of the new prior authorization proposal in the CY 2023 OPPS
proposed rule is beyond the scope of this CY 2023 PFS rule.
To further assist clinicians and interested parties in
understanding more about how we anticipate the CPM services might be
used, members of our clinical team have prepared the following
scenarios to illustrate how the codes might be used in practice.
Scenario 1: An individual clinician sees a new patient who
is seeking to establish care (for example, a general internist sees a
patient who is new to her practice and has a history of chronic pain).
The internist/clinician would need to review the patient's history,
including current and prior medications and treatments tried, and
perform an examination to ascertain the source of the patient's
symptoms as well as an initial functional assessment and develop a care
management plan as part of the visit).
++ This scenario would also likely involve some aspect of
medication management, may include referrals to behavioral health
clinicians, substance use disorder, and/or pain management specialists,
and would most certainly involve scheduling a follow-up appointment
with the internist, which could occur in 1-2 weeks or in several months
(or somewhere in between) depending on the needs of the patient.
++ While other clinicians are involved either through referrals or
to support other elements of the CPM services, it is expected that
generally only one or two clinicians would bill HCPCS code G3002/G3003,
asserting that they are providing the CPM services.
Scenario 2: An individual clinician sees an established
patient who is well known and has a stable care plan and on maintenance
medications (that is, a family physician sees a patient for routine
care to update the care management plan and perform a functional
assessment to ensure that the treatment plan is still supporting the
patient's goals of care).
++ As we stated above, it would be unusual for no medications or
supplements to be involved in the majority of cases of the management
of chronic pain. This may or may not mean the patient is on a chronic
opioid or other medication, and medication management is an almost
universal component of chronic pain management care--even for very
stable patients.
++ Medication management does not only involve management of
medications that the patient is currently taking, but the ability to
recognize when a new medication or over the counter treatment should be
considered as an adjunct to other treatment, to discuss that
recommendation in the context of shared decision-making and to initiate
the pharmacotherapeutic plan of care.
++ Coordination of care (be it the person's behavioral health
treatment or pain management care in general) is critical, and we
mention in the proposed rule language that coordination is expected
``as an element of the CPM codes, the development of and/or revisions
to a person-centered care plan that includes goals, clinical needs, and
desired outcomes, as outlined above and maintained by the practitioner
furnishing CPM services.'' However, not all psychologists are trained
or authorized to coordinate such care as a primary care clinician is
trained, as we have explained.
Scenario 3: An individual clinician provides care to a
patient with multiple chronic conditions (for example, a family
physician sees a patient with a history of chronic low back pain,
obesity, diabetes, and chronic renal insufficiency and routinely must
manage multiple concerns at the same visit).
++ This clinician would likely perform routine functional
assessments of this patient, medication management, ongoing clinical
assessments of their diabetes and kidney function, and discussion of
what their options are when it comes to managing their pain in the
context of these other conditions. As such, without knowing the history
of this patient's conditions, their current medications, past
treatments that have been successful or failures, the clinician cannot
properly manage this patient's chronic pain (for example. changes in
medication must be made in the context of this patients' kidney
function). Additionally, the clinician may wish to offer the patient
non-pharmacologic options for the treatment of their chronic low back
pain, which may include referrals to chiropractic, acupuncture,
physical therapy, massage, cognitive behavioral therapy or other
integrative or complementary/integrative treatments, all of which would
be reasonable discussions to take place in the context of billing HCPCS
codes G3002 and G3003, as appropriate.
[[Page 69545]]
Scenario 4: One individual clinician transfers care of a
patient to another individual clinician in the course of the month (for
example, a family physician refers to a pain management specialist who
then takes over the pain care aspects of a patient with chronic pain).
++ This situation could necessitate two different practitioners
billing HCPCS code G3002 during that first month; the lead clinician
could change to someone else on an infrequent and limited basis,
In summary, we are finalizing code descriptors for HCPCS codes
G3002 and G3003, with two modifications to HCPCS code G3002 shown in
italics, below.
HCPCS code G3002 (Chronic pain management and treatment, monthly
bundle including, diagnosis; assessment and monitoring; administration
of a validated pain rating scale or tool; the development,
implementation, revision, and/or maintenance of a person-centered care
plan that includes strengths, goals, clinical needs, and desired
outcomes; overall treatment management; facilitation and coordination
of any necessary behavioral health treatment; medication management;
pain and health literacy counseling; any necessary chronic pain related
crisis care; and ongoing communication and care coordination between
relevant practitioners furnishing care, e.g. physical therapy and
occupational therapy, complementary and integrative approaches, and
community-based care, as appropriate. Required initial face-to-face
visit at least 30 minutes provided by a physician or other qualified
health professional; first 30 minutes personally provided by physician
or other qualified health care professional, per calendar month. (When
using G3002, 30 minutes must be met or exceeded.))
HCPCS code G3003 (Each additional 15 minutes of chronic pain
management and treatment by a physician or other qualified health care
professional, per calendar month. (List separately in addition to code
for G3002. When using G3003, 15 minutes must be met or exceeded.))
In response to public comments, we are finalizing our proposed
policies pertaining to HCPCS codes G3002 and G3003, with a few
modifications, as follows:
We are defining chronic pain as persistent or recurrent
pain lasting longer than 3 months, as proposed;
We are requiring that the first time HCPCS code G3002 is
billed, the physician or qualified health practitioner must see the
beneficiary in-person. Both individuals must be in a clinical setting
such as a primary care practitioner's office or other applicable
setting, as proposed;
A physician or other qualified health practitioner may
bill HCPCS code G3003, for each additional 15 minutes of care, an
unlimited number of times, as medically necessary, per month, after
HCPCS code G3002 has been billed, as revised;
A work RVU of 1.45 for HCPCS code G3002 and a work RVU of
0.5 for HCPCS code G3003, as proposed;
That any of the CPM in-person components included in HCPCS
codes G3002 and G3003 may be furnished via telehealth, as clinically
appropriate, in order to increase access to care for beneficiaries, as
revised;
That HCPCS codes G3002 and G3003 may be furnished and
billed by physicians and other qualified health professionals, as
proposed; and
That both E/M and CPM may be billed on the same day if all
requirements to report each service are met, and time spent providing
CPM services does not represent time spent for providing any other
reported service, as proposed.
In response to comments expressing lack of clarity about certain
proposed policies pertaining to HCPCS codes G3002 and G3003, we are
clarifying in this final rule that:
The beneficiary, at the first visit, need not have an
established history or diagnosis of chronic pain, or be diagnosed with
a condition that causes or involves chronic pain; but that rather, it
is the clinician's responsibility to establish, confirm, or reject a
chronic pain and/or pain-related diagnosis when the beneficiary first
presents for care and the clinician first reports HCPCS code G3002;
That clinicians will be required to furnish all
appropriate elements of the code bundle, but that we do not expect that
all elements of the code bundle will be appropriate for every patient;
That we are not requiring in the code descriptor that a
clinician refer a beneficiary to other services; that determination
should be made between the clinician and the beneficiary; and finally
That CPM services would be available for billing/reporting
in conjunction with remote patient monitoring, remote physiologic
monitoring, or remote therapeutic monitoring if all requirements to
report each service are met, and time spent providing CPM services does
not represent time spent for any other furnished and billed service.
(34) Revisions to the ``Incident to'' Physicians' Services Regulation
for Behavioral Health Services
In the CY 2014 PFS final rule with comment period (78 FR 74425
through 74427), we created an exception to our ``incident to''
regulation at Sec. 410.26(b)(5) under which ``incident to'' services
generally must be furnished under direct supervision. Specifically, we
finalized a policy to require general, rather than direct, supervision
when chronic care management services are furnished incident to the
billing physician's or NPP's services outside of the practice's normal
business hours by clinical staff. In the CY 2017 PFS final rule (81 FR
80255), we finalized a revision to our regulation under Sec.
410.26(b)(5) to require a general, rather than direct, level of
supervision for designated care management services, and established
that we would designate care management services through notice and
comment rulemaking.
We understand that circumstances related to the PHE for COVID-19
have likely contributed to an increase in the demand for behavioral
health services while also exacerbating existing barriers to
beneficiaries' access to needed behavioral health services. For
example, the American Psychological Association (APA) conducted a
survey in 2020 and a follow-up survey in 2021 to better understand the
impact of the COVID-19 pandemic on mental health treatment and the work
of practicing psychologists. In the 2021 follow-up survey, many
psychologists reported increases in the demand for treatment of anxiety
and depression. They reported the greatest increases in treating
anxiety disorders (84 percent, up from 74 percent), depressive
disorders (72 percent, up from 60 percent), and trauma- and stress-
related disorders (62 percent, up from 50 percent). Other diagnoses
with large increases included sleep-wake disorders, obsessive-
compulsive and related disorders, and substance-related and addictive
disorders.\73\
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\73\ https://www.apa.org/pubs/reports/practitioner/covid-19-2021.
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Additionally, according to HRSA's National Center for Health
Workforce Analysis, by 2025, shortages are projected nationally for a
variety of behavioral health practitioners, including psychiatrists;
clinical, counseling, and school psychologists; mental health and
substance use social workers; school counselors; and
[[Page 69546]]
marriage and family therapists.\74\ Currently, there is no separate
benefit category under the statute that recognizes the professional
services of licensed professional counselors (LPCs) and Licensed
Marriage and Family Therapists (LMFTs). Therefore, payment for the
services of LPCs and LMFTs can only be made under the PFS indirectly
when an LPC or LMFT performs services as auxiliary personnel incident
to, the services, and under the direct supervision, of the billing
physician or other practitioner. According to the American Counseling
Association, there are more than 140,000 licensed professional
counselors (LPCs) in the U.S., and the Medicare program's reimbursement
for mental health treatment services delivered by this professional
group could address provider shortages.\75\ Additionally, according to
the U.S. Bureau of Labor Statistics, there were approximately 54,800
Marriage and Family Therapists (MFTs) as of May 2021.\76\
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\74\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\75\ https://www.counseling.org/government-affairs/federal-issues/medicare-reimbursement.
\76\ https://www.bls.gov/oes/current/oes211013.htm.
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In the 2022 CMS Behavioral Health Strategy,\77\ CMS included a goal
to improve access to and quality of mental health care services. In
light of the current needs among Medicare beneficiaries for improved
access to behavioral health services, and the existing workforce
shortages impeding access to needed treatment for behavioral health, we
have considered regulatory revisions that may help to reduce existing
barriers and make greater use of the services of LPCs and LMFTs. We
noted that CMS does not have authority to create a statutory benefit
category for practitioner types. Therefore, we proposed to amend the
direct supervision requirement under our ``incident to'' regulation at
Sec. 410.26 to allow behavioral health services to be furnished under
the general supervision of a physician or NPP when these services or
supplies are provided by auxiliary personnel incident to the services
of a physician or NPP. We are limiting the scope of this proposal to
behavioral health services at this time due to increased needs for
behavioral health treatment and workforce shortages in this field. We
believe that this proposed change will facilitate utilization and
extend the reach of behavioral health services. We believe that any
risk associated with this proposed change would be minimal, since the
auxiliary personnel providing the services would need to meet all of
the applicable requirements to provide incident to services, including
any applicable licensure requirements imposed by the State in which the
services are being furnished, as described in Sec. 410.26(a)(1).
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We received a high volume of public comments on these proposals.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters stated that they applaud CMS' proposed
revisions to the ``Incident to'' Physicians' Services regulation for
behavioral health services. Commenters stated that this proposal will
help expand access to, and coordination of mental health services in
rural and underserved areas where masters' level practitioners
represent a substantial segment of the mental health providers in the
area and doctoral-level clinicians such as psychologists are few, and
for some patients a long distance away. Further, allowing the
supervision of auxiliary staff such as licensed professional counselors
(LPCs) and marriage and family therapists (MFTs) without requiring a
continuous, direct physical presence would enable more patients to
receive services. Commenters also described that these provisions will
better engage the full panoply of behavioral health care providers in
meeting the needs of Medicare beneficiaries, while further promoting
beneficiary choice to select the type of behavioral health provider
that best suits their mental health needs. Many commenters also noted
that these proposed revisions are essential in light of the fact that
the COVID-19 pandemic has exacerbated rates of depression, loneliness,
and suicide among the elderly population.
Several commenters did not fully support changing the supervisory
requirements from ``direct'' to ``general'' because they noted that
most LPCs and LMFTs possess enough professional knowledge and training
on mental health and addiction to not be under any level of supervision
by a physician or NPP and requested that CMS add a separate benefit
category for LPCs and LMFTs, whom the commenters state comprise 40
percent of the behavioral health workforce, in order to increase access
to behavioral health services for Medicare beneficiaries. However, many
commenters noted that they recognize that without Congressional action,
CMS's ability to expand Medicare beneficiaries' access to LPCs and
LMFTs is limited and stated they support all steps CMS can take to
increase beneficiary access to these practitioners within its
regulatory authority.
A few commenters noted that many mental health counselors practice
in settings where they are not employed by or working directly with
physicians or NPPs and would not be able to take advantage of this
flexibility. Other commenters noted that the proposal to allow LPCs and
LMFTs to furnish behavioral health services under general supervision
is an important step to more effectively deploy behavioral health
professionals to practice at the top of their license, stating that
LPCs could be well positioned to treat patients for conditions
including depression and anxiety, thereby creating greater capacity for
clinical psychologists and other providers with more advanced training
to treat patients with conditions that require more complex care.
Commenters also described that with this new flexibility, primary care
practices may be able to leverage a broader range of behavioral health
professionals in the delivery of team-based integrated primary care,
and therefore, design their workflows in ways to better address the
needs of their patients.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing our
proposal to amend the direct supervision requirement under our
``incident to'' regulation at Sec. 410.26 to allow behavioral health
services to be furnished under the general supervision of a physician
or NPP when these services or supplies are provided by auxiliary
personnel incident to the services of a physician or NPP.
Comment: Many commenters requested that CMS specify which services
are considered ``behavioral health services,'' and would be eligible to
be furnished under general supervision under our proposal. A few
commenters urged CMS to define ``behavioral health services'' under the
broadest terms possible for the purposes of this provision.
Response: We do not define behavioral health services by HCPCS
codes; we did not propose to do so, and we believe individual
practitioners are in the best position to determine whether particular
treatments or diagnostic services are behavioral health services.
However, we generally understand a behavioral health service to be any
service furnished for the diagnosis, evaluation, or treatment of a
mental health disorder, including substance use disorders (SUD). We
note that in the CY 2022 PFS final rule (86 FR 65061), we stated that
SUD services
[[Page 69547]]
are considered mental health services for the purposes of the expanded
definition of ``interactive telecommunications system.'' Additionally,
in the CY 2010 PFS final rule (74 FR 61787), we referenced that the
outpatient mental health treatment limitation, which was phased out as
of 2014, applied to outpatient treatment of a mental, psychoneurotic,
or personality disorders, identified under the International
Classification of Diseases (ICD) diagnosis code range 290-319. These
are the types of behavioral health services that would be eligible to
be furnished by auxiliary personnel under the general supervision of a
physician or certain other nonphysician practitioners who are
authorized under their statutory benefit category to have integral,
although incidental, services provided incident to their own
professional services. Services could include, but are not limited to
services such as psychotherapy, Screening, Brief Intervention, and
Referral to Treatment (SBIRT) services, psychiatric diagnostic
evaluations, and other services furnished primarily for the treatment
or diagnosis of mental health or SUD disorders.
Comment: Many commenters sought clarification regarding which types
of clinicians may serve as auxiliary personnel under this policy. A few
commenters pointed out that terminology for clinicians who furnish
behavioral health care varies across states and requested that CMS
include all independently licensed providers in each state. One
commenter noted an example, that Washington State does not have an LPC
credential, but the equivalent independent license in Washington is a
Licensed Mental Health Counselor, or LMHC, and noted that states that
have alternative titles for comparable credentials would benefit
greatly by being able to use these clinicians to furnish services under
general supervision for Medicare beneficiaries and requested that CMS
consider expanding this proposal to include all those providers with
comparable state-issued licenses. Some commenters encouraged inclusion
of other mid-level clinicians who provide behavioral health treatment
services, such as certified addictions counselors. Other commenters
pointed out a range of clinicians that participate in furnishing
behavioral health treatment, including occupational therapists,
psychiatric pharmacists, and peer support specialists. Another
commenter pointed out that physician assistants are qualified to help
address workforce shortages and access to behavioral health treatment.
Many commenters also highlighted the importance of peer support
services, which commenters stated are designed to value lived
experience and to empower an individual to direct their own recovery
with dignity, noting that integrating peer support services in clinical
settings increases engagement in care and improves both physical and
mental outcomes, and requested clarification as to whether peer support
specialists could be considered auxiliary personnel. A few commenters
noted that under Medicare's partial hospitalization program, CMS
defaults to State licensure laws on which providers are eligible to
provide care, and therefore, encouraged CMS to adopt, for the purposes
of this provision, deference to State licensure laws where the care is
taking place.
Response: We note that the definition of auxiliary personnel at
Sec. 410.26(a)(1) defines auxiliary personnel as any individual who is
acting under the supervision of a physician (or other practitioner),
regardless of whether the individual is an employee, leased employee,
or independent contractor of the physician (or other practitioner) or
of the same entity that employs or contracts with the physician (or
other practitioner), has not been excluded from the Medicare, Medicaid
and all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in which the services are
being furnished. We note that we did not propose any changes to the
existing regulatory definition of auxiliary personnel in Sec. 410.26,
and therefore, we are not making any changes to this definition in this
rule. All requirements for services furnished incident to a physician's
or NPP's professional services listed at Sec. 410.26 continue to
apply. Many of the clinician types mentioned by commenters could
satisfy this definition.
Comment: Several commenters requested that CMS create a mechanism
for licensed psychologists to bill Medicare for the services furnished
by advanced psychology trainees under a licensed psychologist's
supervision, noting this is allowed by many State Medicaid programs.
The commenters stated that clinical psychology interns have 1,000 to
2,000 hours of clinical experience prior to beginning their internship,
but under current Medicare rules, they are not able to independently
bill Medicare, which leaves psychology training programs without a
steady source of funding and prevents trainees from gaining valuable
experience working with older patients and patients with disabilities.
Additionally, several commenters requested that CMS include behavioral
health providers who are in the process of seeking full licensure, such
as associate marriage and family therapists and State licensed
associate counselors, as auxiliary personnel. The commenters noted that
these are individuals who have met their state's graduate education and
exam requirements but have not yet met the supervised experience
requirement.
Response: We thank the commenters for their feedback; however, we
note that these comments are outside of the scope of our proposed
change to the required level of supervision for behavioral health
services furnished incident to a physician, NPP, or CP, because we did
not propose any changes to Medicare payment rules regarding interns or
postdoctoral students.
Comment: A few commenters stated they opposed the expansion of NPPs
scope of practice beyond their State license, education, and training.
One commenter stated that while they recognize the important services
these practitioners provide on the care team, Medicare patients--most
of whom have multiple chronic conditions, in addition to complex
behavioral health issues--should have access to primary care and
specialty physician services. They stated they believe that NPPs should
be under the direct supervision of a licensed physician and work within
the care team. Several commenters urged CMS to defer to State laws and
leave the scope of practice to the State legislatures and State
licensing boards. Another commenter noted that scope of practice is
determined by one's licensure in the State and supervision can ensure
safe delivery of that care. One commenter encouraged CMS to conduct
data collection and research on the care provided by LPCs and LMFTs
prior to expanding the policy to other providers to ensure patients are
receiving the best quality care to meet their needs. A few commenters
stated they oppose any supervisory changes that undermine the oversight
of physician-led health care teams. One commenter expressed concern
that under general supervision, the supervising clinician usually
provides oversight to a larger number of non-medical behavioral health
clinicians, which creates an obstacle to providing immediate feedback
when needed and suggested that guardrails are needed to ensure that
appropriate psychiatric consultation is available.
[[Page 69548]]
Response: The change to the level of supervision for ``incident
to'' behavioral health services from direct to general does not alter
the longstanding regulatory definition of auxiliary personnel.
Accordingly, any individual who qualifies as auxiliary personnel under
the ``incident to'' regulations at Sec. 410.26, which requires
services to be furnished in accordance with applicable State law, will
continue to qualify as such, regardless of the required level of
supervision assigned to the services. The definition of general
supervision requires the services to be furnished under the physician's
(or other practitioner's) overall direction and control. These
requirements must be met for the physician or practitioner to bill for
the behavioral health service. In the case where State law and scope of
practice are silent about whether an individual serving in the capacity
of auxiliary personnel is licensed/authorized to provide a given
behavioral health service, the supervision level for the provision of
the behavioral health service will default to the standard direct
supervision requirement for ``incident to'' services. Additionally, in
order for payment to be made under Medicare Part B for the services and
supplies incident to the services of a physician or other practitioner,
the service must be an integral, though incidental, part of the service
of the physician or practitioner in the course of diagnosis or
treatment of an injury or illness, in accordance with Sec. 410.26(b).
For this to be met, we would expect there to be a course of treatment
established by the physician or practitioner and in which the physician
or practitioner is actively participating and managing.
Comment: Several commenters expressed support for CMS allowing
behavioral health services to be furnished under general supervision in
the RHC and FQHC settings as well, and a few commenters encouraged CMS
to utilize its regulatory authority to amend the FQHC ``incident to''
regulations and FQHC mental health visit to include an encounter
performed by an LPC and LMFT to generate a billable visit in Medicare
to better align with Medicaid.
Response: We appreciate these suggestions from the commenters. We
note that for CY 2023, the proposed change to the level of supervision
for ``incident to'' behavioral health services from direct to general
was applicable only to services payable under the PFS, which means
services furnished in the RHC and FQHC settings were not addressed in
the relevant proposal in the CY 2023 PFS proposed rule (87 FR 46062
through 46068). We may consider changes to the regulations regarding
services furnished at RHCs and FQHCs in the future. Additionally, we
note that the types of practitioners' services that can be considered
RHC and FQHC services are specified in section 1861(aa)(1) and (3) of
the Act, respectively, and do not include the services of LPCs and
LMFTs.
Comment: One commenter suggested that CMS require a claims modifier
when services are billed ``incident to'' which could indicate the type
of personnel who performed the service (for example, LPC, LMFT,
clinical psychologist, clinical social worker). The commenter stated
that because this proposal would relax the supervision policy for
behavioral health services billed as ``incident to'' services,
transparency is necessary to understand the impacts of this change,
evaluate the quality of behavioral health care provided, monitor the
use of services, and inform future improvements.
Response: We thank the commenter for this suggestion. We may
consider a claims modifier for billing ``incident to'' services broadly
for future rulemaking.
Comment: Several commenters raised potential impacts for
beneficiaries who are dually eligible for Medicare and Medicaid. A few
commenters urged CMS to clarify that LPCs may be reimbursed by the
Medicaid program for services they provide to dually-eligible Medicare
beneficiaries, without documentation of a Medicare claim denial or,
alternatively, create a protocol to provide such a denial so that the
Medicaid program will process the claim.
Response: We thank commenters for this information and feedback,
but we note that this rule focuses on supervision, not which party will
be reimbursed for furnishing behavioral health services. We note that
this policy is limited to the change in the required level of
supervision for behavioral health services furnished by auxiliary
personnel incident to the services of a physician or NPP, and
therefore, we do not anticipate that this policy would have an effect
on the processing of crossover claims for beneficiaries who are dually
eligible for Medicare and Medicaid.
(35) New Coding and Payment for General Behavioral Health Integration
(BHI) Billed by Clinical Psychologists (CPs) and Clinical Social
Workers (CSWs)
In the CY 2017 PFS final rule (81 FR 80230), we established G-codes
to describe monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99492-99494,
which we established for payment under the PFS in the CY 2018 PFS final
rule (82 FR 53077 and 53078). Additionally, we created a fourth G-code
to describe services furnished using other models of BHI in the primary
care setting, which was replaced by CPT code 99484 in the CY 2018 PFS
final rule (82 FR 53077 and 53078).
We stated in the CY 2017 PFS final rule (81 FR 80236) that we
recognized that the psychiatric CoCM is prescriptive and that much of
its demonstrated success may be attributable to adherence to a set of
elements and guidelines of care. We finalized a code set to pay
accurately for care furnished using this specific model of care, given
its widespread adoption and recognized effectiveness. However, we
stated we recognized that there are primary care practices that are
incurring, or may incur, resource costs inherent to treatment of
patients with similar conditions based on BHI models of care other than
the psychiatric CoCM that may benefit beneficiaries with behavioral
health conditions, and therefore, finalized a General BHI code which
may be used to report a range of models of BHI services, and that we
expected this code to be refined over time as we receive more
information about other BHI models in use.
In the CY 2018 PFS final rule (82 FR 53078), we stated that we had
received inquiries from interested parties about whether professionals
who were not eligible to report the approved initiating visit codes for
BHI services to Medicare might nonetheless serve as a primary hub for
BHI services. For example, interested parties have suggested that a CP
might serve as the primary practitioner that integrates medical care
and psychiatric expertise. For purposes of future rulemaking, we sought
comment on the circumstances under which this model of care is
happening and whether additional coding would be needed to accurately
describe and value other models of care. A few commenters suggested
that CMS create separate codes to describe behavioral health care
management services that could be billed by CPs and NPPs who are not
authorized to bill Medicare for E/M services. One commenter suggested
that CMS include psychiatric diagnostic evaluation services that can be
furnished and billed by CPs as eligible initiating visits. Commenters
also
[[Page 69549]]
described other models of care that are in use, including the STAR-VA
model and a model used in outpatient health care settings where a
clinical social worker (CSW) not only furnishes psychiatric care but
also assists with psychosocial aspects of medical care.
In the CY 2017 PFS final rule (81 FR 80239), we stated that we had
received a few comments suggesting that in addition to the qualifying
E/M services (or an AWV or IPPE), the initiating visit services for BHI
should include in-depth psychological evaluations delivered by a CP
including CPT codes 90791, 96116 or 96118, which include care plan
development. In this final rule, we established that the same services
that qualify as the initiating visit for CCM would also qualify as
initiating services for BHI, which do not include in-depth
psychological evaluation by a CP and which were not, in their entirety,
within the scope of CPs' practice, and therefore, CPs would not be able
to report the General BHI code directly (although a psychiatrist may be
able to do so) (81 FR 80239).
In the 2022 CMS Behavioral Health Strategy,\78\ we included a goal
to improve access to and quality of mental health care services, and
included an objective to ``increase detection, effective management
and/or recovery of mental health conditions through coordination and
integration between primary and specialty care providers.'' As
previously noted in this proposed rule, we understand that
circumstances related to the COVID-19 PHE have likely contributed to an
increase in the demand for behavioral health services while also
exacerbating existing barriers in beneficiaries' access to needed
behavioral health services. In light of the feedback we have received
and considering the increased needs for mental health services, we
proposed to create a new G code describing General BHI performed by CPs
or CSWs to account for monthly care integration where the mental health
services furnished by a CP or CSW are serving as the focal point of
care integration. Specifically, we proposed to create HCPCS code GBHI1
(Care management services for behavioral health conditions, at least 20
minutes of clinical psychologist or clinical social worker time, per
calendar month, with the following required elements: initial
assessment or follow-up monitoring, including the use of applicable
validated rating scales; behavioral health care planning in relation to
behavioral/psychiatric health problems, including revision for patients
who are not progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination with and/or
referral to physicians and practitioners who are authorized by Medicare
law to prescribe medications and furnish E/M services, counseling and/
or psychiatric consultation; and continuity of care with a designated
member of the care team.) We proposed to value this service under the
proposed HCPCS code GBHI1 based on a direct crosswalk to the work
values and direct PE inputs for CPT code 99484 (Care management
services for behavioral health conditions, at least 20 minutes of
clinical staff time, directed by a physician or other qualified health
care professional, per calendar month, with the following required
elements: initial assessment or follow-up monitoring, including the use
of applicable validated rating scales; behavioral health care planning
in relation to behavioral/psychiatric health problems, including
revision for patients who are not progressing or whose status changes;
facilitating and coordinating treatment such as psychotherapy,
pharmacotherapy, counseling and/or psychiatric consultation; and
continuity of care with a designated member of the care team), because
the services described by GBHI1 closely mirror those described by CPT
code 99484. Therefore, we believe that this crosswalk is an appropriate
valuation of the level, time, and intensity of the proposed service
described by HCPCS code GBHI1. CPs are authorized under their statutory
benefit category at section 1861(ii) of the Act to furnish ``qualified
psychologist services'' to include ``such services and such services
and supplies furnished as an incident to his service furnished by a
clinical psychologist (as defined by the Secretary) which the
psychologist is legally authorized to perform under State law (or the
State regulatory mechanism provided by State law) as would otherwise be
covered if furnished by a physician or as an incident to a physician's
service.'' Additionally, the statutory benefit category for CSWs at
Section 1861(hh)(2) of the Act defines ``clinical social worker
services'' as ``services performed by a clinical social worker (as
defined in paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a hospital
and other than services furnished to an inpatient of a skilled nursing
facility which the facility is required to provide as a requirement for
participation) which the clinical social worker is legally authorized
to perform under State law (or the State regulatory mechanism provided
by State law) of the State in which such services are performed as
would otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.'' Based on the
authorizations under the CP and CSW statutory benefit categories, CPs
are authorized to furnish and bill for services that are provided by
clinical staff incident to their professional services when the
``incident to'' requirements specified in Sec. 410.26 of our
regulations are met, and would be authorized to do the same when
furnishing services described by proposed HCPCS code GBHI1, whereas
CSWs would only be able to bill Medicare for services they furnish
directly and personally. The proposed work value for HCPCS code GBHI1
is 0.61 (based on a direct crosswalk to CPT code 99484). We solicited
comment on whether this proposed value accurately reflects the resource
costs involved in furnishing these models of care, or whether
additional coding may be needed, for example, separate coding for CPs
and CSWs. We also solicited comment on the proposed requirements for
billing GBHI1, including any applicable ``incident to'' requirements,
and the role and responsibilities of CSWs and CPs.
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In the CY 2017 PFS final rule (81 FR 80239), we finalized the
requirement of an initiating visit for the BHI codes for new patients
or beneficiaries not seen within a year of commencement of BHI
services. We stated that the initiating visit would establish the
beneficiary's relationship with the billing practitioner (most aspects
of the BHI services would be furnished incident to the billing
practitioner's professional services), ensure the billing practitioner
assesses the beneficiary prior to initiating care management processes,
and provide an opportunity to obtain beneficiary consent. We noted that
the existing eligible initiating visit codes are not, in their
entirety, within the scope of the CP's practice. Given that, we
proposed to allow a psychiatric diagnostic evaluation (CPT code 90791)
to serve as the initiating visit for GBHI1. We welcome comment on
whether we should consider additional codes to qualify as the
initiating visit.
In the CY 2017 PFS final rule (81 FR 80235), we established that
CCM and BHI services could be billed during the same month for the same
beneficiary if all the requirements to bill each service are separately
met. We are also proposing that HCPCS code GBHI1 could be billed during
the same month as CCM and TCM services, provided
[[Page 69550]]
that all requirements to report each service are met and time and
effort are not counted more than once. The patient consent requirements
would apply to each service independently.
In the CY 2017 PFS final rule (81 FR 80235), we established that
the BHI services may be furnished incident to the billing
professional's services under general supervision because we do not
believe it is clinically necessary that the professionals on the team
who provide services other than the treating practitioner (namely, the
behavioral health care manager and the psychiatric consultant) to have
the billing practitioner immediately available to them at all times, as
would be required under a higher level of supervision. We believe this
is also the case for the service described by GBHI1. Therefore,
consistent with other care management codes paid under the PFS, we
proposed to add HCPCS code GBHI1 to the list of designated care
management services for which we allow general supervision.
We received public comments on new coding and payment for general
behavioral health integration (BHI) billed by Clinical Psychologists
(CPs) and Clinical Social Workers (CSWs). The following is a summary of
the comments we received and our responses.
Comment: Many commenters supported our proposed coding and payment
for BHI that would recognize psychologists' role in integrated care.
The commenters expressed support for recognizing multiple evidence-
based models of integrated care, stating this allows psychologists the
flexibility required to support the behavioral health needs of the
broader community. Other commenters noted that by providing access to
behavioral health and health behavior services within primary care
settings, BHI services can be particularly helpful in addressing
treatment disparities affecting members of racial and ethnic
minorities, and those living in underserved and vulnerable communities
with inadequate access to mental and behavioral health specialists. A
few commenters stated this proposal will provide additional flexibility
to primary care practices to design their workflows to best suit the
needs of beneficiaries and the care team's capacities. Commenters noted
that the establishment of this code will also help to recognize
psychologists' role in integrated care and allow psychologists the
flexibility required to support the behavioral health needs of the
broader community. Other commenters pointed out that a potential
advantage of the proposed service code is that HCPCS code GBHI1
appropriately adds additional autonomy to CP and CSW clinical practice,
which has the potential to improve job satisfaction and retention.
Additionally, commenters stated that allowing for reimbursement of
measurement-based care, interprofessional coordination, and care
management services may incentivize more CPs and CSWs to participate in
the Medicare behavioral health clinician network, which would in turn
increase patient access to care management services and behavioral
health treatment driven by validated outcome measurements. Commenters
also expressed support for allowing these services to be furnished
under general supervision.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing this
code as proposed. We note that the code GBHI1 was a placeholder code
and that the final code number will be HCPCS code G0323 (Care
management services for behavioral health conditions, at least 20
minutes of clinical psychologist or clinical social worker time, per
calendar month. (These services include the following required
elements: Initial assessment or follow-up monitoring, including the use
of applicable validated rating scales; behavioral health care planning
in relation to behavioral/psychiatric health problems, including
revision for patients who are not progressing or whose status changes;
facilitating and coordinating treatment such as psychotherapy,
coordination with and/or referral to physicians and practitioners who
are authorized by Medicare to prescribe medications and furnish E/M
services, counseling and/or psychiatric consultation; and continuity of
care with a designated member of the care team.))
Additionally, we are finalizing our proposal to add HCPCS code
G0323 to the list of designated care management services for which we
allow general supervision.
Comment: Several commenters stated they agreed with CMS that CPT
code 90791 (psychiatric diagnostic evaluation) could appropriately
serve as the initiating visit, noting that psychologists and social
workers are not able to bill E/M services. A few commenters also
requested that CPT code 96156, health behavior assessment and
reassessment, also serve as an allowable initiating visit for the newly
proposed BHI code. Another commenter urged CMS to broaden the types of
visits that can serve as an initiating visit for HCPCS code GBHI1,
stating that a visit with a primary care provider or social worker
would also be appropriate initial visit types and that limiting the
initiating visit to a psychiatric diagnostic evaluation undermines CMS'
intent to expand access to wraparound services for individuals
receiving mental health services.
Response: We appreciate the commenters suggestion about considering
other CPT codes such as 96156 (health behavior assessment, or
reassessment), as well as E/M visit codes in addition to CPT code 90791
(psychiatric diagnostic evaluation) to serve as the initiating visit
for GBHI1. However, when considering that CPs and CSWs cannot bill the
program for E/M visits because they are not licensed by the States to
furnish such services and, that the range of health behavior assessment
and intervention codes are for billing primarily for physical illnesses
rather than psychiatric illnesses, we believe that 90791 is the best
option that aligns with the services that CPs and CSWs are authorized
to furnish under State law and scope of practice. Accordingly,
recognizing a code for which CPs and CSWs can bill as an initiating
visit for HCPCS code G0323 offers them greater access and opportunity
to furnish integrated care management services.
Comment: A few commenters expressed concern about the medical
management of patients in models of care without psychiatric
involvement and suggested that the ability to receive immediate advice
on prescribing from a psychiatrist or child psychiatrist, as is the
case in the existing evidence-based psychiatric CoCM model, should be a
mandatory element in all other collaborative care models to ensure
patient safety and high-quality patient care. A commenter also pointed
to the existing interprofessional consultation codes (CPT codes 99446-
99449, 99451-99452) and urged CMS to emphasize the importance of
consultative relationships between psychiatrists, primary care
physicians, clinical psychologists, and clinical social workers in
order to ensure high-quality care.
Response: We thank the commenters for this feedback. In the CY 2017
PFS final rule (81 FR 80236 through 80238), we noted that we created
the General BHI code in order to allow payment for models of integrated
care other than the psychiatric collaborative care (CoCM) code. We
agree with the comment regarding the importance of consultative
relationships between various members of the care team, including
psychiatrists, primary care physicians, clinical psychologists, and
clinical social workers.
[[Page 69551]]
Comment: Many commenters supported the proposed valuation based on
a crosswalk to CPT code 99484. A few commenters opposed the proposed
valuation, stating that CPT code 99484 describes clinical staff time
and is valued assuming the service is performed by a behavioral health
care manager and that those assumptions do not accurately reflect the
cost when the service is performed by a clinical psychologist or
clinical social worker. Another commenter stated they do not believe
this proposed value accurately reflects the resource costs involved in
furnishing these models of care as the amount of time needed to
complete the required elements will take far longer than 20 minutes per
month and there is a substantial amount of work that occurs outside of
the office. The commenter urged CMS to consider a code that permits
multiple billable units of 20 minutes per unit per month capped at 10
units per month to better acknowledge the amount of time it takes to
adequately perform the required elements, as well as the critical
effort that occurs outside the office visit.
Response: We thank the commenters for this feedback. After
consideration of the comments, for CY 2023, we are finalizing the value
of HCPCS code G0323 as proposed, however we may consider changes in how
this code is valued for future rulemaking. We note that the commenter's
suggestion regarding codes that permit multiple billable units of 20
minutes per unit per month is outside of the scope of the proposal.
Comment: A few commenters requested that CMS clarify whether HCPCS
code GBHI1 may be billed in conjunction with codes describing remote
monitoring services. The commenter stated they support the new code but
sought clarification on whether HCPCS code GBHI1 could be billed in
conjunction with the following services: remote patient monitoring (CPT
code 99091), remote physiologic monitoring (CPT codes 99453, 99454,
99457, 99458), or remote therapeutic monitoring (CPT codes 98975,
98976, 98977, 98980, 98981 and as proposed GRTM1/2/3/4) codes.
Response: HCPCS code G0323, and the services describing remote
patient monitoring, remote physiologic monitoring, and remote
therapeutic monitoring, are distinct types of services, although there
may be some overlap in eligible patient populations. There may be some
circumstances where it is reasonable and necessary to provide both
services in a given month. The BHI codes, including HCPCS code G0323,
could be billed for the same patient in the same month as the RPM or
RTM services. All applicable requirements for the individual codes must
be met, including obtaining informed consent from the beneficiary, for
both the remote monitoring and BHI. In this circumstance, appropriate
billing in a given month means that time and effort cannot be counted
more than once when using BHI codes with RPM or RTM. Billing
practitioners should remember that cost sharing applies to each service
independently. If all requirements to report each service are met,
without time or effort being counted more than once, both may be
billed.
Comment: Several commenters requested that CMS clarify that
providers of peer support services (also known as peer support
specialists and peer recovery specialists) may bill as part of
behavioral health integration codes including the new GBHI1 code and
collaborative care codes.
Response: While there is no statutory benefit category under
Medicare law that authorizes direct billing and payment to peer support
specialists for their professional services under the Medicare Part B
program, it may be possible for peer support specialists to provide
their services in an ``incident to'' capacity. That is, if a peer
support specialist meets the definition of auxiliary personnel as
defined under the ``incident to'' regulations at Sec. 410.26, then
they could be eligible to provide behavioral health services within
their scope of practice in accordance with State law under the
supervision of a physician or certain nonphysician practitioners.
Comment: One commenter suggested that CMS should consider use of
telehealth visits to meet the initiating visit criteria as this would
serve to increase access in alignment with CMS' stated goal. Another
commenter encouraged CMS to monitor utilization of the code if
finalized and noted that the type of work described is resource
intensive and needs to be valued accordingly. Another commenter stated
they supported the proposed crosswalk, but it was unclear to them
whether the current valuation is accurate, stating that CPT code 99484
will be reviewed by the RUC at their September 2022 meeting.
Response: We may consider these commenters' suggestions for future
rulemaking. Additionally, we intend to monitor utilization of this code
and any subsequent changes to the valuation of CPT code 99484 in order
to determine whether we may need to re-visit the valuation through
future rulemaking.
Comment: One commenter encouraged CMS to consider broadening the
scope of services in this code to include coordination of social care.
The commenter stated that the behavioral health care manager will be
more successful in getting individuals successfully engaged in
treatment if they are able to attend to basic resources and social
needs by referring to relevant social services and programs and that
counting minutes spent coordinating mental health treatment but not
minutes spent helping address other concerns is burdensome for
clinicians and does not make sense clinically when it is all part of a
typical evidence-based clinical social work interventions that result
from a comprehensive psychosocial assessment and collaborative planning
process to work toward the overarching goal (in this case, improved
behavioral health).
Response: We appreciate the commenters suggested consideration of
making payment for coordination of social services. We did not propose
to include coordination of social care in HCPCS code G0323, so for this
reason we will not be finalizing such a change. As we continue to
consider ways to expand access to behavioral health services, we may
consider this for future rulemaking.
Comment: A few commenters stated they support additional coding to
promote integration and recommended that CMS develop a bundled payment
for behavioral health services that would include wraparound services
and could be used in value-based payment arrangements.
Response: We appreciate these suggestions. While they are out of
scope for this proposed rule, we may consider additional coding to
promote integration and payment through future rulemaking.
(36) Request for Information: Medicare Part B Payment for Services
Involving Community Health Workers (CHWs)
The American Public Health Association (APHA) defines a community
health worker as a ``frontline public health worker who is a trusted
member of and/or has an unusually close understanding of the community
served. This trusting relationship enables the worker to serve as a
liaison/link/intermediary between health/social services and the
community to facilitate access to services and improve the quality and
cultural competence of service delivery.'' Community Health Workers are
classified as a workforce category by the Department of Labor. The
Community Health Worker Core
[[Page 69552]]
Consensus Project (C3) lists the following ten roles of CHWs: \79\
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\79\ St John, J.A., Mayfield-Johnson, S.L., & Hern[aacute]ndez-
Gordon, W.D. (2021). Introduction: Why Community Health Workers
(CHWs)? In Promoting the Health of the Community (pp. 3-10).
Springer, Cham.
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Cultural mediation among individuals, communities, and
health and social service systems.
Providing culturally appropriate health education and
information.
Care coordination, case management, and system navigation.
Providing coaching and social support.
Advocating for individuals and communities.
Building individual and community capacity.
Providing direct service.
Implementing individual and community assessments.
Conducting outreach.
Participating in evaluation and research.
Findings from randomized controlled trials indicate that particular
CHW interventions reduce chronic disease disparities in low income,
racial and ethnic minority communities, such as type 2 diabetes,
hypertension, HIV/AIDS, and obesity.\80\ \81\ \82\ \83\ \84\ We are
also interested in better addressing the social needs of beneficiaries;
for example, in the FY 2023 IPPS/LTCH proposed rule, we proposed new
measures under the Hospital Inpatient Quality Reporting Program
pertaining to assessing social determinants of health. The CHW skillset
may position this workforce to address these social needs. In light of
the significant benefits that services involving CHWs can potentially
offer the health of Medicare beneficiaries, including a reduction in
health disparities, we are interested in learning more about how
services involving CHWs are furnished in association with the specific
Medicare benefits established by the statute.
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\80\ Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA.
Community Health Worker Support for Disadvantaged Patients With
Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public
Health. 2017;107(10):1660-1667. doi:10.2105/AJPH.2017.303985.
\81\ Cooper L.A., Roter D. L., Carson K. A., et al. A randomized
trial to improve patient-centered care and hypertension control in
underserved primary care patients. J Gen Intern Med.
2011;26(11):1297-1304.
\82\ Spencer MS, Rosland AM, Kieffer EC, Sinco BR, Valerio M,
Palmisano G, et al. Effectiveness of a community health worker
intervention among African American and Latino adults with type 2
diabetes: a randomized controlled trial. Am J Public Health. 2011
Dec;101(12):2253-60.
\83\ Brown LD, Vasquez D, Lopez DI, Portillo EM. Addressing
Hispanic Obesity Disparities Using a Community Health Worker Model
Grounded in Motivational Interviewing. Am J Health Promot.
2022;36(2):259-268.
\84\ Kenya, S., Jones, J., Arheart, K. et al. Using Community
Health Workers to Improve Clinical Outcomes Among People Living with
HIV: A Randomized Controlled Trial. AIDS Behav 17, 2927-2934 (2013).
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Over the past several years, we have worked to develop payment
mechanisms under the PFS to improve the accuracy of valuation and
payment for the services furnished by physicians and other health care
professionals, especially in the context of evolving models of care.
For example, physicians and other eligible practitioners are able to
report care management services and behavioral health integration
services based on tasks personally provided by clinical staff under
their supervision. Some of the elements of the comprehensive care plans
referenced in the description of care management services include
medication management, community/social services ordered, and
coordination with other agencies, which are also some of the services
personally provided by CHWs.
Section 1862(a)(1)(A) of the Act generally excludes from coverage
services that are not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member. We are interested in learning whether and how
CHWs, as auxiliary personnel of physicians and hospitals, may provide
reasonable and necessary services to Medicare beneficiaries under the
appropriate supervision of health care professionals that are
responsible more broadly for medical care, including behavioral health
care. We are also looking to understand whether and how services
involving CHWs are accounted for under the existing CCM codes or other
care management or behavioral health integration services, including
whether the employment and supervision arrangements ordinarily adopted
within the industry would meet the requirements that allow for billing
by supervising professionals or providers, including RHCs and FQHCs.
For example, do CHWs tend to be employees of physicians or of the same
entities that employ physicians? Are physicians or other medical
professionals supervising their interaction with patients in a manner
consistent with direct supervision--for example, immediate availability
in the same location?
We noted that CHWs are employed in a number of sectors, including
local government, community-based organizations, and social services
sectors. Therefore, the health care providers working with CHWs may
have established nontraditional relationships with these organizations
outside of the health sector. We are interested in learning how
payments between health care provider organizations, and community-
based organizations, local governments, and social service
organizations, account for the costs of services provided by CHWs, and
how health care provider organizations ensure that the funding amount
is sufficient to cover the costs of the full range of CHW services. We
also solicited comment on whether and to what extent CHW services are
provided in association with preventive services, including those
covered by Medicare.
Physicians and certain other health care practitioners are
authorized to bill Medicare for services furnished incident to their
professional services by auxiliary personnel. Our regulation at Sec.
410.26 requires that auxiliary personnel who perform services incident
to the services of the billing physician or other practitioner must be
acting under the supervision of the billing practitioner, and must meet
any applicable requirements, including licensure, imposed by the State
in which the services are furnished. We understand that there is wide
variation in State standards for CHWs. In addition, the training that
CHWs receive is typically provided by employers but varies widely in
terms of its breadth and scope.\85\ We are trying to understand how
CHWs might also be recognized as auxiliary personnel in the Medicare
context, and are therefore interested in learning how States may have
determined whether and under what circumstances CHWs have the necessary
qualifications to perform services that would improve the health of
Medicare beneficiaries and others being treated by supervising
professionals or providers.
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\85\ Fasting, D., Mayfield-Johnson, S.L., St. John, J.A., &
Hern[aacute]ndez-Gordon, W.D. (2021). In Promoting the Health of the
Community (pp. 43-52). Springer, Cham.
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We received several public comments in response to our request for
information about Medicare Part B Payment for Services Involving
Community Health Workers (CHWs). We appreciate the thoughtful feedback
submitted by the public on this matter and may consider these comments
in future rulemaking.
(37) Recognition of the Nurse Portfolio Credentialing Commission (NPCC)
The Medicare program established qualifications under regulations
at Sec. 410.75 for NPs and, under Sec. 410.76 for clinical nurse
specialists (CNS). Both the NP and CNS qualification regulations
require that NPs and CNSs be certified as a NP or a CNS by a
[[Page 69553]]
recognized national certifying body that has established standards for
NPs and/or CNSs, and that a listed certifying body must be approved by
the Secretary. An identical list of Medicare recognized and approved
national certifying bodies for NPs and CNSs is included under Chapter
15, section 200 and 210 of the Medicare Benefit Policy Manual, pub.
100-02.
The organizations listed under program manual instructions as
recognized national certifying bodies for NPs and CNSs are as follows:
American Academy of Nurse Practitioners;
American Nurses Credentialing Center;
National Certification Corporation for Obstetric,
Gynecologic and Neonatal Nursing Specialties;
Pediatric Nursing Certification Board (previously named
the National Certification Board of Pediatric Nurse Practitioners and
Nurses);
Oncology Nurses Certification Corporation;
AACN Certification Corporation; and
National Board on Certification of Hospice and Palliative
Nurses.
The Nurse Portfolio Credentialing Commission (NPCC) has requested
to have its organization added to the lists of recognized national
certifying bodies for NPs and CNSs who specialize in clinical genetics/
genomics and are awarded the Advanced Clinical Genomics Nurse (ACGN)
credential. The NPCC's request to CMS describes the NPCC as a non-
profit organization, established in 2018 by genetics/genomics nurse
leaders as the only organization that now offers new credentials to
advanced practice registered nurses (APRNs) who specialize in genetics/
genomics, a nursing specialty recognized by the American Nurses
Association.
Additionally, the NPCC's letter states that its organization
evolved directly from the American Nurses Credentialing Center (a
listed, CMS-recognized national certifying body) and the Genetic
Nursing Credentialing Commission, which are the organizations that
awarded new genetics/genomics nursing credentials from 2001 to 2018.
However, as of 2019, the American Nurses Credentialing Center (ANCC)
stopped offering new credentialing to genetics nurses and instead
offers only renewal credentialing to nurses who specialize in genetics.
Since 2019, the NPCC has awarded the ACGN credential to 32 APRNs from
17 States.
Now, with the NPCC being the only organization that offers new
credentialing to nurses in genetics, the NPCC is concerned that the
absence of its organization from the current list of recognized
national certifying bodies appropriate for NPs and CNSs presents a
barrier and a disadvantage for newly credentialed APRNs. Specifically,
the NPCC is concerned that newly NPCC credentialed NPs and CNSs seeking
enrollment under Medicare would be denied on the basis that they do not
meet Medicare's certification requirement unless the NPCC is listed as
a recognized national certifying body appropriate for NPs and CNSs who
specialize in genetics/genomics. The website for the NPCC is available
at https://www.nurseportfolio.org.
When considering previous requests to add other organizations to
the list of recognized national certifying bodies for NPs and CNSs, we
stated that it is not our intention to be overly restrictive in our
program requirements and consequently prevent qualified NPs and CNSs
who specialize in areas of medicine other than those certified by the
ANCC from participating in the Medicare program as NPs or CNSs and from
rendering care to patients in need of specialized services (see 71 FR
69707). Accordingly, we proposed to add the NPCC organization to the
list of recognized national certifying bodies in manual instructions
for NPs at section 200 and CNSs at section 210 of the Medicare Benefit
Policy Manual, pub. 100-02. We requested public comments on this
proposal.
The following is a summary of the public comments received on our
proposal concerning the NPCC, along with our response to these
comments.
Comment: One commenter stated that its organization is concerned
that the addition of the NPCC to the list of recognized national
certifying bodies for NPs and CNSs would create confusion between the
national certifying bodies for NPs and CNSs that are already listed
under program manual instructions and, the NPCC. The commenter
described the NPCC as a type of credentialing organization that
provides an additional credential in advanced clinical genomics to
demonstrate expertise in a specific specialty area to already certified
and licensed NPs and CNSs. Therefore, the commenter asserted that since
the list of recognized national certifying bodies in program manual
instructions lists the organizations that provide the certification
necessary to practice under Medicare as a NP or a CNS in accordance
with Medicare regulations, it does not support adding the NPCC, which
offers a specialty credential that goes beyond the requisite
qualification requirements for NPs and CNSs.
Response: We appreciate the commenters concern about creating
confusion by adding the NPCC to the list of recognized national
certifying bodies for NPs and CNSs. When establishing this list of
recognized national certifying bodies for NPs and CNSs, we were
cautious about being overly restrictive in our program requirements and
consequently preventing qualified NPs and CNSs who specialize in areas
of medicine other than those certified by the American Nurses
Credentialing Corporation (ANCC) from participating in the Medicare
program as NPs or CNSs and from rendering care to patients in need of
specialized services. Accordingly, the current list recognizes
organizations that certify NPs and CNSs with specialties in obstetrics,
gynecology, neonatal nursing, pediatrics, oncology, hospice and
palliative care. It is our intent to exercise this same caution when
considering additional prospects given the current severe shortage of
health care professionals such as NPs and CNSs available to render care
to patients, particularly those who are certified and furnish
specialized services. Since the ANCC no longer offers new credentialing
to genetics nurses, the NPCC is the only organization that offers new
credentialing for this nurse specialty. Therefore, our consideration to
recognize and list the NPCC is to prevent the potential for such
genetics nurses from being denied enrollment in the Medicare program.
Comment: Another commenter stated that CMS should recognize the
NPCC as a national certifying body for NPs and CNSs.
Response: We appreciate the support of our proposal. After
considering the public comments on the NPCC proposal, we are finalizing
our proposal to recognize and add the NPCC to the list of national
certifying bodies that is housed in our program manual instructions in
the Medicare Benefit Policy Manual, pub. 100-02, at Chapter 15, section
200 for NPs and, 210 for CNSs.
(38) Request for Information: Medicare Potentially Underutilized
Services
Medicare provides payment for many kinds of services that support
beneficiaries in promoting health and well-being and that may also, in
some cases, reduce unnecessary spending within the health care system
by decreasing the need for more expensive kinds of care. Some examples
of these services may include patient
[[Page 69554]]
educational services, like Diabetes Self-Management Training or
preventive services, like the Annual Wellness Visit.
We solicited comments on ways to identify specific services and to
recognize possible barriers to improved access to these kinds of high
value, potentially underutilized services by Medicare beneficiaries. We
also solicited regarding how we might best mitigate some of these
obstacles, including for example, through examining conditions of
payment or payment rates for these services or by prioritizing
beneficiary and provider education investments.
We discussed that ``high value'' health services have been
described as those ``services that provide the best possible health
outcomes at the lowest possible cost.'' \86\ The American College of
Physicians states that high value services seek ``to improve health,
avoid harms, and eliminate wasteful practices.'' \87\ However, we
described that we believe that some high value Medicare services may be
potentially underutilized by beneficiaries. In some cases, limited use
of these kinds of services occurs disproportionately in underserved
communities.
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\86\ ``Michigan Program on Value Enhancement.'' Institute for
Healthcare Policy & Innovation (28 Apr. 2022). https://ihpi.umich.edu/featured-work/michigan-program-value-enhancement.
\87\ High value care. ACP. (n.d.). (May 9, 2022). https://www.acponline.org/clinical-information/high-value-care.
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Disparities in health and healthcare persist despite decades of
research and widespread efforts to improve health outcomes in the
United States.\88\ Certain populations, including groups experiencing
racial disparity, people with disabilities, individuals dually eligible
for Medicare and Medicaid, and those living in rural and underserved
areas are more likely to experience challenges accessing healthcare
services, lower quality of care, and below average health outcomes when
compared to the general population.89 90 91 Many known
factors impede efficient and equitable healthcare, including workforce
challenges, transportation issues, healthcare costs, language barriers,
a lack of health literacy, and confusion about health insurance
coverage and processes.\92\ Additional factors include social
determinants of health and community-level burdens that contribute to
the exacerbation of health disparities. For example, disparities in
cancer screening and treatment across racial and ethnic groups have
been well documented. Research demonstrates that minority populations
are less likely to receive cancer screening tests than their white
counterparts and, consequently, are more likely to be diagnosed with
late-stage cancer.\93\ Additionally, racial and ethnic minorities with
positive test results are more likely to experience delays in receiving
the diagnostic tests that would serve to confirm cancer diagnoses.\94\
We are committed to building solutions that will help close gaps in
healthcare quality, access, and outcomes.\95\
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\88\ Office of Minority Health. (2021, January, page 3). Paving
the Way to Equity: A Progress Report. Centers for Medicaid and
Medicare Services. https://www.cms.gov/files/document/paving-way-equity-cms-omh-progress-report.pdf.
\89\ Agency for Health Care Research and Quality (AHRQ). (2021,
June). 2019 National Healthcare Quality and Disparities Report.
AHRQ. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr19/index.html.
\90\ Executive Order No. 13985, 86 FR 7009 (2021, January 20).
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/. For the
purposes of this RFI, we are using the definitions of equity and
underserved communities established in Executive Order 13985, ``The
term `equity' means the consistent and systematic fair, just, and
impartial treatment of all individuals, including individuals who
belong to underserved communities that have been denied such
treatment, such as Black, Latino, and Indigenous and Native American
persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) persons; persons with disabilities;
persons who live in rural areas; and persons otherwise adversely
affected by persistent poverty or inequality.'' The term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life.
\91\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health & Human. Services. Second
Report to Congress on Social Risk Factors and Performance in
Medicare's Value-Based. Purchasing Program. 2020. https://aspe.hhs.gov/reports/second-report-congress-social-risk-medicares-value-based-purchasing-programs.
\92\ Lahr, M., Henning-Smith, C., Rahman, A., Hernandez, A.
(2021, January). Barriers to Health Care Access for Rural Medicare
Beneficiaries: Recommendations from Rural Health Clinics. University
of Minnesota Rural Health Research Center. https://rhrc.umn.edu/wp-content/uploads/2021/01/UMN-RHC-Access-to-Care-PB_1.20.pdf.
\93\ Agency for Healthcare Research and Quality [AHRQ], 2004;
National Institutes of Health/National Cancer Institute [NIH/NCI],
2001). Racial and ethnic minorities with positive test results are
more likely to experience delays in receiving the diagnostic tests
needed to confirm cancer diagnoses (Battaglia et al., 2007; Ries et
al., 2003.
\94\ Battaglia et al., 2007; Ries et al., 2003.
\95\ Office of Minority Health. (2021, January). Paving the Way
to Equity: A Progress Report. Centers for Medicaid and Medicare
Services. https://www.cms.gov/files/document/paving-way-equity-cms-omh-progress-report.pdf.
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We noted that we are working to advance health equity by designing,
implementing, and operationalizing policies and programs that support
health for all the people served by our programs, eliminating avoidable
differences in health outcomes experienced by people who are
disadvantaged or underserved, and providing the care and support that
our beneficiaries need to thrive.\96\ Health equity as defined by CMS
\97\ means the attainment of the highest level of health for all
people, where everyone has a fair and just opportunity to attain their
optimal health regardless of race, ethnicity, disability, sexual
orientation, gender identity, socioeconomic status, geography,
preferred language, or other factors that affect access to care and
health outcomes. More information regarding CMS's Strategic Plan for
health equity is available in the CMS Strategic Plan Pillar: Health
Equity Fact Sheet: https://www.cms.gov/sites/default/files/2022-04/Health%20Equity%20Pillar%20Fact%20Sheet_1.pdf.
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\96\ https://www.cms.gov/pillar/health-equity.
\97\ https://www.cms.gov/sites/default/files/2022-04/Health%20Equity%20Pillar%20Fact%20Sheet_1.pdf.
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In light of the concerns regarding the potential underutilization
of high value health services, particularly among potentially
underserved communities, we are committed to promoting these high value
services within the Medicare program. In concert with the CMS strategy
to advance health equity in addressing health disparities that underlie
our health system, we stated that we seek to engage with interested
parties and solicit comment regarding ways to identify and improve
access to high value, potentially underutilized services by Medicare
beneficiaries.
We solicited comment on how to best define and identify high value,
potentially underutilized health services. We also stated that we are
also looking to understand what existing services within current
Medicare benefits may represent high value, potentially underutilized
services, such as:
Preventive Services;
Annual Wellness Visits;
Diabetes Management Training;
Screening for Diabetes;
Referral to appropriate education/prevention/training
services
Immunizations/vaccinations
Cancer screenings
Cardiac rehabilitation services
Intensive Behavioral Therapy for obesity
Opioid treatment programs
Complex/Chronic Care Management
Cognitive Assessment & Care
Behavioral Health Integration Services
[[Page 69555]]
Other examples of Medicare preventive services are available at the
following website: https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html.
We invited the public to submit information about specific
obstacles to accessing these services and how specific potential
policy, payment or procedural changes could reduce potential obstacles
and facilitate better access to high value health services.
Specifically, we solicited new and innovative ideas that may help
broaden perspectives about potential solutions. Ideas may include, but
are not limited to:
Educational or marketing strategies (informed by
beneficiary input) to promote awareness of available programs and
resources that advance the utilization of ``high value'' services;
Aligning of Medicare and other payer coding, payment and
documentation requirements, and processes related to ``high value''
services;
Recommendations from States and other interested parties
regarding how to best raise awareness of underutilized services, with
special consideration for the dual-eligible population;
Enabling of operational flexibility, feedback mechanisms,
and data sharing that would enhance the utilization of ``high value''
services; and
New recommendations regarding when and how CMS issues
regulations and policies related to ``high value'' services and how CMS
can advance rules and policies for beneficiaries, clinicians, and
providers.
We stated that we are interested in learning about how CMS might
best promote high value care and health equity, address concerns
regarding health disparities, and increase access to high value
services, which could improve the health of Medicare beneficiaries. We
also noted that comments received in response to this RFI may be used
to identify potential opportunities for improvement to and refinement
of existing Medicare FFS and MA programs.
We received numerous comments on our request for information about
Medicare Potentially Underutilized Services. We appreciate the
thoughtful feedback submitted by the public on this important issue and
plan to consider these suggestions for possible future rulemaking and
program refinement.
(39) Change in Procedure Status for Family Psychotherapy
The CPT codes that describe family psychotherapy are payable under
Medicare, but are currently assigned a restricted status indicator in
the Medicare Physician Fee Schedule payment files. The codes describing
family psychotherapy with the patient present are CPT code 90847
(Family psychotherapy (conjoint psychotherapy) (with patient present),
50 minutes) and CPT code 90849 (Multiple-family group psychotherapy).
We noted that CPT code 90846 (Family psychotherapy (without the patient
present), 50 minutes) describes family psychotherapy without the
patient present. In past rulemaking, we have discussed that Medicare
has generally taken the stance that coverage is limited to items and
services that are for the diagnosis and treatment of the individual
beneficiary.
During the COVID-19 pandemic, the number of adults reporting
adverse behavioral health conditions has increased sharply, with higher
rates of depression, substance use, and self-reported suicidal thoughts
observed in racial and ethnic minority groups.\98\ We are seeking to
ensure that appropriate care is furnished to Medicare beneficiaries and
noted that CPT codes 90847 and 90849 are payable under Medicare.
Accordingly, we proposed to update our payment files to remove the
restricted (``R'') procedure status indicator for CPT codes 90847 and
90849 and assigning these codes an active (``A'') procedure status
indicator.
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\98\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm.
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We noted that there are national coverage determinations (NCDs)
addressing family psychotherapy described by CPT codes 90847 and 90849
describing the settings of care in which these services are covered,
documentation requirements and other guidelines.\99\ The Medicare
National Coverage Determinations (NCD) Manual, Pub. 100-03, section
70.1, titled ``Consultations with a Beneficiary's Family and
Associates'' states that ``family counseling services are covered only
where the primary purpose of such counseling is the treatment of the
patient's condition.'' \100\ The change to the ``A'' status indicator
for these subject CPT codes does not alter the policy under the
applicable coverage determinations for these codes.
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\99\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57065&ver=10&keyword=&keywordType=starts&areaId=all&docType=6,3,5,1,F,P&contractOption=all&hcpcsOption=code&hcpcsStartCode=90847&hcpcsEndCode=90847&sortBy=title&bc=1.
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We received public comments on the change in procedure status for
family psychotherapy. The following is a summary of the comments we
received and our responses.
Comment: Several commenters expressed support for our proposal to
change the procedure status indicator for the family therapy codes
(90847, 90849) from R (restricted) status to A (active) status. A few
commenters stated that this change will remove a barrier to care, while
some noted that there remain national coverage determinations carrying
documentation requirements and guidelines that the MACs can consider
and ultimately use to restrict coverage. One commenter stated they
believed that CPT code 90846 should also not be restricted, as this is
an important service particularly for adolescents, families of
substance use disorder patients, and families attempting to manage
behavioral manifestations of dementia.
Response: In response to the comment requesting that the procedure
status for CPT code 90846, which describes psychotherapy without the
patient present, be updated to an active status, we thank the commenter
for this feedback and may consider changes to the procedure status for
CPT code 90846 in the future. After consideration of the comments, we
are finalizing our updates to the procedure status indicators for CPT
codes 90847 and 90849--both will be assigned an A for active status,
effective January 1, 2023.
(40) Comment Solicitation on Intensive Outpatient Mental Health
Treatment, including Substance Use Disorder (SUD) Treatment, Furnished
by Intensive Outpatient Programs (IOPs)
There are a range of services described by existing coding under
the PFS that can be billed for treatment of mental health conditions,
including SUDs, such as individual, group, and family psychotherapy.
Over the past several years, in collaboration with interested parties
and the public, we have increased the coding and payment mechanisms for
substance use treatment services paid under the PFS. For example, in
the CY 2020 PFS final rule (84 FR 62673), we finalized the creation of
new coding and payment describing a bundled episode of care for the
treatment of Opioid Use Disorder (OUD) (HCPCS codes G2086-G2088). In
the CY 2021 PFS final rule, we finalized expanding the bundled payments
described by HCPCS codes G2086-
[[Page 69556]]
G2088 to be inclusive of all SUDs (85 FR 84642 and 84643).
Additionally, in the CY 2020 PFS final rule (84 FR 62630 through
62677), we implemented coverage requirements and established new codes
describing bundled payments for episodes of care for the treatment of
OUD furnished by Opioid Treatment Programs (OTPs). Medicare also covers
services furnished by inpatient psychiatric facilities and partial
hospitalization programs (PHP). PHP services can be furnished by a
hospital outpatient department or a Medicare-certified Community Mental
Health Center (CMHC). PHPs are structured to provide intensive
psychiatric care through active treatment that utilizes a combination
of the clinically recognized items and services described in Sec.
1861(ff) of the Social Security Act (the Act). According to the
Medicare Benefit Policy Manual, Chapter 6, Section 70.3, the treatment
program of a PHP closely resembles that of a highly structured, short-
term hospital inpatient program and is at a level more intense than
outpatient day treatment or psychosocial rehabilitation. PHPs work best
as part of a community continuum of mental health services which range
from the most restrictive inpatient hospital setting to less
restrictive outpatient care and support.
We understand that in some cases, people that do not require a
level of care for mental health needs that meets the standards for PHP
services, nonetheless require intensive services on an outpatient
basis. We are interested in whether or not the current coding and
payment mechanisms under the PFS adequately account for intensive
outpatient services that are part of a continuum of care in the
treatment. For example, according to SAMHSA's Advisory on Clinical
Issues in Intensive Outpatient Treatment for Substance Use Disorders,
IOP programs for substance use disorders (SUDs) offer services to
clients seeking primary treatment; step-down care from inpatient,
residential, and withdrawal management settings; or step-up treatment
from individual or group outpatient treatment. IOP treatment includes a
prearranged schedule of core services for example, individual
counseling, group therapy, family psychoeducation, and case management)
for a minimum of 9 hours per week for adults or 6 hours per week for
adolescents. The 2019 National Survey of Substance Abuse Treatment
Services reports that 46 percent of SUD treatment facilities offer IOP
treatment.\101\
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\101\ https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep20-02-01-021.pdf.
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We solicited comment on whether there is a gap in coding under the
PFS or other Medicare payment systems that may be limiting access to
needed levels of care for treatment of mental health or substance use
disorder treatment, including and especially SUDs, for Medicare
beneficiaries. We are particularly interested in the extent to which
any potential gaps would best be addressed by the creation of new
codes, revision of particular billing rules for some kinds of care in
specific settings, or whether the valuation of particular codes
(existing or new) needs to be addressed in order to better reflect the
relative resource costs involved in furnishing intensive outpatient
mental health services. We are also interested in additional, detailed
information about IOP services, such as the settings of care in which
these programs typically furnish services, the range of services
typically offered, the range of practitioner types that typically
furnish those services, and any other relevant information, especially
to the extent it would inform our ability to ensure that Medicare
beneficiaries have access to this care.
We received several public comments in response to our comment
solicitation on intensive outpatient mental health treatment, including
SUD treatment, furnished by IOPs. We appreciate the feedback submitted
by the public on this matter, including support for providing care
along the full continuum of behavioral health services, the settings of
care in which IOP services are typically furnished, the service
elements that are typically included in IOP treatment, and potential
options for valuation of such services, and may consider these comments
in future rulemaking.
(41) Comment Solicitation on Payment for Behavioral Health Services
Under the PFS
As discussed throughout this final rule, we are committed to
ensuring that beneficiaries have access to needed services for mental
and behavioral health. Through the CMS Behavioral Health Strategy, CMS
seeks to remove barriers to care and services, and to adopt a data-
informed approach to evaluate our behavioral health programs and
policies. We strive to support a person's whole emotional and mental
well-being and promote person-centered behavioral health care.\102\
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\102\ https://www.cms.gov/cms-behavioral-health-strategy.
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As part of our review of our payment policies and systems, we
understand that the PFS ratesetting methodology and application of
budget neutrality may impact certain services more significantly than
others based on factors such as how frequently codes are revalued and
the ratio of physician work to PE. In the CY 2018 PFS final rule (82 FR
52999), we discussed that some interested parties had suggested that
for codes in which direct PE inputs for a service are very low, the
methodology for allocating indirect PE does not allow for a site of
service differential that accurately reflects the relative indirect
costs involved in furnishing services in non-facility settings. We
stated that primary therapy and counseling services available to
Medicare beneficiaries for treatment of behavioral health conditions,
including substance use disorders, are among the services most affected
by our methodology.
We solicited comment on how we can best ensure beneficiary access
to behavioral health services, including any potential adjustments to
the PFS ratesetting methodology, for example, any adjustments to
systematically address the impact on behavioral health services paid
under the PFS.
We received several public comments in response to our comment
solicitation on payment for behavioral health services under the PFS.
We appreciate the feedback submitted by the public on this matter and
may consider these comments in future rulemaking.
(42) Payment for Interstitial Device Remote Monitoring (HCPCS Code
G2066)
We received comments regarding payment changes for cardiovascular
remote monitoring services described by HCPCS code G2066. We note that
we did not make any proposal to change the payment rate of HCPCS code
G2066, we are not finalizing any changes to the payment rate for HCPCS
code G2066, and that these comments are out of the scope of our
proposed rule. However, after considering the comments, we acknowledge
the concerns raised by interested parties regarding price transparency
and payment stability for certain contractor priced services.
We believe it is important for interested parties to continue to
engage with their local MAC to address these concerns about price
transparency and payment stability for contractor priced services.
Ideally, these interactions would support dialogue that address the
specific concern about lack of transparency, through the sharing of
applicable and requested information, which in turn supports the MACs
payment decision process. We believe that to the extent such requested
information is shared, MACs would be
[[Page 69557]]
willing to engage in a discussion about the information, including how
their review of the information relates to their payment decisions.
This ongoing dialogue would also allow the MACs to make determinations
about how to effectuate their payments decision to address the concerns
about payment stability, that is, the requested information and
engagements would provide a better understanding of the impact of
payment changes on interested parties, and inform MAC consideration for
allowing interested party adjustment to any payment changes through
advance communication, or use of transition periods.
(43) Radiation Oncology Model
On August 29, 2022, CMS finalized delaying the current start date
of the Radiation Oncology Model (ROM) to a date to be determined
through future rulemaking. In the CY 2020 PFS final rule (84 FR 62797),
we finalized that, in the interest of payment stability, we would
continue to maintain current coding for radiation treatment services,
including HCPCS G-codes with their current work RVUs and direct PE
inputs, given the introduction of the RO Model, and to prevent
disruption in beneficiary access to radiation treatment services. While
we did not make any proposals for payment for these radiation treatment
services under the PFS for CY 2023, we note that we are reviewing our
current coding and payment policies for the radiation therapy services,
including whether we should adopt the revised CPT coding that was
established in CY 2015 to allow for coding and payment consistency,
considering the fact that CMS finalized delaying the current start date
of the ROM earlier this year. Any such changes would be addressed in
future rulemaking.
BILLING CODE 4150-28-P
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F. Evaluation and Management (E/M) Visits
1. Background
Over the past several years, we have engaged in a multi-year effort
with the American Medical Association (AMA) and other interested
parties to update coding and payment for evaluation and management (E/
M) visits, so that they better reflect the current practice of
medicine, are less administratively complex, and are paid more
accurately under the PFS. This work is critical to help reduce
practitioner burnout in general, especially in light of the COVID-19
pandemic. In a step-wise approach, the AMA CPT Editorial Panel revised
the office/outpatient (O/O) E/M visit code family first. Effective
January 1, 2021, the CPT Editorial Panel redefined the O/O E/M visits,
such that visit level is selected based on the amount of practitioner
time spent performing the visit or the level of medical decision-making
(MDM) as redefined in the CPT E/M Guidelines. Additionally, effective
January 1, 2021, history of present illness (History) and a physical
exam are no longer used to select the O/O E/M visit level. (See 85 FR
84549). Also, effective January 1, 2021, the CPT Editorial Panel
revised the O/O E/M visit descriptor times and the CPT E/M Guidelines.
We generally adopted these revised codes and changes in CPT code
selection and documentation guidance for payment purposes under the PFS
effective January 1, 2021 (84 FR 62844 through 62859). While we
accepted the revised CPT codes and approach for the O/O E/M visits, we
did not accept the revisions for prolonged O/O services, because we
were concerned that they could have resulted in overpayment, were
administratively complex, and would have impacted our ability to tell
how much total time was spent with the patient (see 84 FR 62849 through
62850,
[[Page 69587]]
and 85 FR 84572 through 84575). We created G2212 for reporting of
prolonged O/O E/M services. Finally, the AMA RUC resurveyed the O/O E/M
visits, and we generally accepted the RUC recommendations, which
reflected increased service times (84 FR 62851 through 62854). This
resulted in increased values for the O/O E/M codes beginning in CY
2021. Also, we created add-on code G2211 (office/outpatient E/M visit
complexity) that can be reported in conjunction with O/O E/M visits to
better account for resources associated with primary care or care
services that are part of ongoing care related to a patient's single,
serious, or complex chronic condition(s). (84 FR 62854 through 62856).
The Consolidated Appropriations Act, 2021 imposed a moratorium on
Medicare payment for these services by prohibiting CMS from making
payment under the physician fee schedule for HCPCS code G2211 before
January 1, 2024. See our fact sheet available at Physician Fee Schedule
(PFS) Payment for Office/Outpatient Evaluation and Management (E/M)
Visits--Fact Sheet \103\ (cms.gov).
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\103\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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For CY 2023, the AMA CPT Editorial Panel has revised the rest of
the E/M visit code families (except critical care services) to match
the general framework of the O/O E/M visits, including inpatient and
observation visits, emergency department (ED) visits, nursing facility
visits, domiciliary or rest home visits, home visits, and cognitive
impairment assessment. Hereafter in this final rule, we refer to these
other E/M visit code families as ``Other E/M'' visits or CPT codes, as
relevant. Effective January 1, 2023, the CPT Editorial Panel has
redefined the Other E/M visits so that they parallel the O/O E/M
visits, where visit level will be selected based on the amount of
practitioner time spent with the patient or the level of MDM as
redefined in the CPT E/M Guidelines. As for the O/O E/M visits, a
medically appropriate history and/or physical exam will be a required
element of the services, but will no longer impact the Other E/M visit
level. The CPT Editorial Panel also revised the service times within
the descriptors, the associated prolonged service codes, and the CPT E/
M Guidelines for the Other E/M CPT codes. The CPT Editorial Panel also
consolidated a considerable number of the Other E/M CPT codes, with
inpatient and observation visits being combined into a single code set,
and home and domiciliary visits being combined into a single code set.
Currently there are approximately 75 Other E/M CPT codes, and in 2023
there will be approximately 50 Other E/M CPT codes. The CPT Editorial
Panel created one new CPT code for prolonged inpatient services by
physicians and other qualified healthcare professionals on the date of
the E/M visit. Finally, the RUC has resurveyed the Other E/M visits and
associated prolonged service codes, and provided revaluation
recommendations to CMS.
In total, E/M visits comprise approximately 40 percent of all
allowed charges under the PFS. The subset of Other E/M visits comprises
approximately 20 percent of all allowed charges. Accordingly, our final
policies for the Other E/M visits will have a significant impact on
relative resource valuation under the PFS, which could potentially
impact patient care more broadly. In this section of our final rule, we
provide our final policies addressing coding and revaluation of Other
E/M visits for CY 2023. We also finalize a technical correction to the
placement of our regulation text for split (or shared) visits, and, as
we further consider feedback from interested parties, we delay
implementation of our policy to define the substantive portion of a
split (or shared) visit at Sec. 415.140 based on the amount of time
spent by the billing practitioner until January 1, 2024. Finally, we
provide clarification and finalize a technical correction regarding how
time is reported for split (or shared) critical care visits.
2. Overview of Policy Proposals
In our proposed rule, we proposed to generally adopt the revised
CPT E/M Guidelines for Other E/M visits, which are available online at
www.ama-assn.org/cpt-evaluation-management. We proposed to adopt the
general CPT framework for Other E/M visits, such that practitioner time
or MDM would be used to select the E/M visit level. This includes the
listing of qualifying activities by the physician or NPP that count
toward the time spent when time is used required to select the visit
level. A medically appropriate history and/or examination would be
required, but history and physical exam would no longer be used to
select visit level. We would not adopt the general CPT rule \104\ where
a billable unit of time is considered to have been attained when the
midpoint is passed (for example, we would not consider a service with a
time descriptor of 30 minutes to have been satisfied if only 15 minutes
of time had been spent furnishing that service). We similarly
interpreted this rule for O/O E/M visits, when time is used to select
visit level. For example, we required the full time within the CPT code
descriptors to be met in order to select an O/O E/M visit level using
time, rather than half of the descriptor time (84 FR 62848 through
62851). Also, we do not interpret the CPT E/M Guidelines as adopting
this general CPT rule regarding the midpoint of time.
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\104\ Introduction to 2022 CPT Codebook, p.xviii.
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We proposed to adopt the revised CPT codes and descriptors for
Other E/M visits, except where specified otherwise. Under our proposed
policies, we would adopt the new CPT codes and descriptors for Other E/
M visits except for prolonged services, for which we proposed Medicare-
specific coding. For administrative simplicity and payment accuracy
purposes, and to enable us to determine how much time was spent with
the patient using claims data, prolonged Other E/M services would be
reported under one of three proposed G codes (one for each family for
which prolonged services apply, namely inpatient/observation visits,
nursing facility visits, and home or residence visits). This would be
consistent with our previously finalized approach to prolonged O/O E/M
services.
We proposed to adopt the CPT E/M Guidelines regarding MDM for E/M
services. The CPT Editorial Panel revised the CPT E/M guidelines for
levels of MDM, and we proposed to adopt them as revised.
In addition, as we noted in the Medicare Claims Processing Manual
((pub 100-04) chapter 26, section 10.8), our longstanding taxonomy for
PFS services will continue to apply, where, for payment purposes,
physicians and NPPs are not classified as having the same specialty,
and the PFS does not recognize subspecialties. However, we are
continuing to consider whether we could better align this payment
taxonomy with clinical practice, where we might consider NPPs as
working in the same specialty as the physicians with whom they work,
and/or recognize subspecialties.
Regarding valuation of the Other E/M CPT codes, the RUC recommended
direct work RVU comparisons for many Other E/M CPT codes to those
currently assigned to O/O E/M CPT codes. In some cases, there were
assumptions that patient needs were inherently more complex or work was
more intense for E/M visits furnished in non-office settings (for
example, inpatient, ED, and home settings) when compared to the office
settings. This direct comparison to the O/O visit codes may not be
appropriate or accurate, given that practitioners furnishing visits in
the
[[Page 69588]]
office setting face particular uncertainties in their estimates of
illness and treatment courses, and the office settings have fewer
resources close at hand. For example, compared to fully-staffed
institutional settings, office settings generally have smaller,
ancillary staff complements (such as pharmacists, registered nurses,
social workers, and other paraprofessionals) who provide specialized
advice and services, spend time coordinating with other practitioners
for review and evaluation of medical records and test results, educate
patients, manage medications, and assess and help address social
determinants of health. Additionally, those practicing in institutional
settings generally have ready availability of diagnostic equipment (for
example, imaging and other advanced services), allowing for more
immediate access to clinical information and reducing the amount of
time needed to manage a given case. This access is critical for
positive health outcomes, to treat or prevent acute exacerbations of
chronic conditions and timely manage patients to prevent deterioration
and improve outcomes. The challenge of coordinating and gathering these
types of care and information in the office setting may add additional
time and complexity to the case management. Further, some of the Other
E/M CPT code families are being merged into lower complexity settings,
such as CPT codes for observation services migrating into the inpatient
visit CPT codes.
The values we established for the revised O/O E/M CPT codes in the
CY 2021 PFS final rule were finalized in concert with a policy that
would have provided separate payment for the new add-on code G2211.
This add-on code describes the complexity inherent to E/M visits
associated with primary care and other similar types of care
(specifically, E/M visits associated with medical care services that
serve as the continuing focal point for all needed health care services
and/or with medical care services that are part of ongoing care related
to a patient's single, serious condition or a complex condition,
regardless of the specialty of the billing professional) (see 85 FR
84569 through 84572). Section 113 of the Consolidated Appropriations
Act, 2021 delayed Medicare payment for G2211 until at least January 1,
2024 (see the following Fact Sheet available on our website at
Physician Fee Schedule \105\ (PFS) Payment for Office/Outpatient
Evaluation and Management (E/M) Visits--Fact Sheet (cms.gov). To the
extent we proposed to adopt the RUC-recommended values for Other E/M
visits beginning for CY 2023, we do not agree with the RUC that the
current visit payment structure among and between care settings fully
accounts for the complexity of certain kinds of visits, especially for
those in the office setting, nor do they fully reflect appropriate
relative values, since separate payment is not yet made for G2211.
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\105\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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We note that we received a few comments that mentioned the
commenters believe the CPT rule for midpoint of time applies to the CPT
E/M Guidelines and other CPT reporting instructions, and recommended we
do the same. We reiterate that we have not interpreted the CPT
reporting instructions this way, and they will not apply for PFS
reporting of E/M visits. To avoid payment variation and standardize
reporting, it would be helpful if CPT would explicitly clarify in the
CPT E/M Guidelines that the midpoint rule for reporting of timed
services does not apply.
We also received a few comments questioning whether we were
formally proposing a change in taxonomy for NPPs to recognize clinical
categories for them or subspecialties for E/M visit reporting, and are
recommending such. We are continuing to consider these issues, and
wanted to call attention to the differences between the CPT reporting
instructions and the PFS reporting rules. We would need more time and
rulemaking to develop taxonomy changes and systems changes, and are not
finalizing any changes in our policies at this time.
3. Hospital Inpatient or Observation Care (CPT Codes 99218-99236)
a. Coding Changes and Visit Selection for Hospital Inpatient or
Observation Care Services
The CPT Editorial Panel deleted seven observation care codes and
revised nine codes effective January 1, 2023, to create a single set of
codes for inpatient and observation care. (Note that the CPT Editorial
Panel also made changes to codes for inpatient and observation
discharge, which will be discussed in section II.F.4. of this final
rule.) The CPT Editorial Panel also changed the code descriptors to
allow level of service to be based on total time or MDM, as well as
updating associated reporting instructions and CPT E/M Guidelines.
The CPT Editorial Panel deleted the six codes that were used to
report observation care visits: three initial observation care codes,
CPT codes 99218 (Initial observation care, per day, for the evaluation
and management of a patient which requires these 3 key components: A
detailed or comprehensive history; a detailed or comprehensive
examination; and medical decision making that is straightforward or of
low complexity). Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the problem(s) requiring admission to
outpatient hospital ``observation status'' are of low severity.
Typically, 30 minutes are spent at the bedside and on the patient's
hospital floor or unit), 99219 (Initial observation care, per day, for
the evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; a comprehensive examination; and
medical decision making of moderate complexity). Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission to outpatient hospital ``observation
status'' are of moderate severity. Typically, 50 minutes are spent at
the bedside and on the patient's hospital floor or unit), and 99220
(Initial observation care, per day, for the evaluation and management
of a patient, which requires these 3 key components: A comprehensive
history; a comprehensive examination; and medical decision making of
high complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the problem(s) requiring admission to
outpatient hospital ``observation status'' are of high severity.
Typically, 70 minutes are spent at the bedside and on the patient's
hospital floor or unit); and three subsequent observation care codes,
CPT codes 99224 (Subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: Problem focused interval history; problem
focused examination; medical decision making that is straightforward or
of low complexity. Counseling and/or coordination of care with other
physicians, other qualified
[[Page 69589]]
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient is stable, recovering, or improving. Typically, 15
minutes are spent at the bedside and on the patient's hospital floor or
unit), 99225 (Subsequent observation care, per day, for the evaluation
and management of a patient, which requires at least 2 of these 3 key
components: An expanded problem focused interval history; an expanded
problem focused examination; medical decision making of moderate
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is responding inadequately
to therapy or has developed a minor complication. Typically, 25 minutes
are spent at the bedside and on the patient's hospital floor or unit),
and 99226 (Subsequent observation care, per day, for the evaluation and
management of a patient, which requires at least 2 of these 3 key
components: A detailed interval history; a detailed examination;
medical decision making of high complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
patient is unstable or has developed a significant complication or a
significant new problem. Typically, 35 minutes are spent at the bedside
and on the patient's hospital floor or unit).
The CPT Editorial Panel also revised the six hospital inpatient
care codes. The revisions allow these codes to be reported for hospital
inpatient or observation care services and allow the codes to be
selected by the billing practitioner based on either MDM or time. In
addition, the CPT Editorial Panel changed the name of the ``Hospital
Inpatient Care'' code family to ``Hospital and Observation Care,'' and
the new code family includes three initial hospital or observation care
codes: CPT codes 99221 (Initial hospital inpatient or observation care,
per day, for the evaluation and management of a patient, which requires
a medically appropriate history and/or examination and straightforward
or low-level medical decision-making. When using total time on the date
of the encounter for code selection, 40 minutes must be met or
exceeded), 99222 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
encounter for code selection, 55 minutes must be met or exceeded), and
99223 (Initial hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making When using total time on the date of the encounter for
code selection, 75 minutes must be met or exceeded); and three
subsequent inpatient or observation care codes, CPT codes 99231
(Subsequent hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and straightforward or low level
of medical decision making. When using total time on the date of the
encounter for code selection, 25 minutes must be met or exceeded),
99232 (Subsequent hospital inpatient or observation care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using total time on the date of the encounter for
code selection, 35 minutes must be met or exceeded), and 99233
(Subsequent hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using total time on the date of the encounter for
code selection, 50 minutes must be met or exceeded).
The CPT Editorial Panel also revised the three codes under
``Observation or Inpatient Care Services (including Admission and
Discharge)'' (frequently referred to as ``same-day discharge'' codes).
Billing practitioners could already use these codes to bill for
patients in inpatient or observation status, but the CPT Editorial
Panel revised the codes to allow the billing practitioner to select the
code level based either on MDM or time. The same-day discharge codes
were renamed as ``Hospital Inpatient or Observation Care (Admission and
Discharge)'': CPT codes 99234 (Hospital inpatient or observation care,
for the evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and straightforward or low level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded), 99235 (Hospital
inpatient or observation care, for the evaluation and management of a
patient including admission and discharge on the same date, which
requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using total time on the
date of the encounter for code selection, 70 minutes must be met or
exceeded), and 99236 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using total time on the date of the encounter for code selection,
85 minutes must be met or exceeded).
We proposed to adopt the revised CPT codes 99221 through 99223 and
99231 through 99236. We highlighted that the CPT code descriptors
specify that, when selecting the code level based on time, the
indicated increment of time must be ``met or exceeded.'' We proposed
that, when a practitioner selects CPT codes 99221 through 99223 and
99231 through 99236 based on time, the number of minutes specified in
the descriptor for the relevant CPT code must be ``met or exceeded.''
We noted that we did not propose to adopt the 2023 CPT Codebook
instructions regarding the application of prolonged codes to CPT codes
99223, 99233, and 99236. (2023 CPT Codebook, p. 15-17). Please refer to
the additional discussion of prolonged codes in section II.F.3.f.
below.
We also noted that the descriptors for CPT codes 99221 through
99223 and 99231 through 99236 specify that the time counted toward the
code is ``per day.'' We proposed to adopt the 2023 CPT Codebook
instruction that ``per day,'' also referred to as ``date of
encounter,'' means the ``calendar date.'' (2023 CPT Codebook, p. 15.)
We also proposed to adopt the 2023 CPT Codebook instruction that when
using MDM or time for code selection, a continuous service that spans
the transition of 2 calendar dates is a single service and is reported
on one date, which is the date the encounter begins. If the service is
continuous before and through midnight, all the time may be applied to
the reported date of the service, that is, the calendar date the
encounter began. (2023 CPT Codebook, p.15.) We noted that nothing in
this proposal was intended to conflict with our proposed retention of
the ``8 to 24-
[[Page 69590]]
hour rule,'' discussed in the next section.
Finally, we proposed to retain our policy that a billing
practitioner shall bill only one of the hospital inpatient or
observation care codes for an initial visit, a subsequent visit, or
inpatient or observation care (including admission and discharge), as
appropriate, once per calendar date. We proposed that the practitioner
would select a code that reflects all of the practitioner's services
provided during the date of the service, as provided in the Medicare
Claims Processing Manual, IOM 100-04, Chapter 12, section
30.6.9.B.\106\ We discussed additional policies relating to a single
billing practitioner providing services to a single beneficiary on the
same day in section II.F.3.d. below.
---------------------------------------------------------------------------
\106\ The manual states, ``A/B MACs (B) pay a physician for only
one hospital visit per day for the same patient, whether the
problems seen during the encounters are related or not. The
inpatient hospital visit descriptors contain the phrase ``per day''
which means that the code and the payment established for the code
represent all services provided on that date. The physician should
select a code that reflects all services provided during the date of
the service.''
---------------------------------------------------------------------------
Comment: Many commenters supported our proposal to adopt both the
CPT's consolidation of the Hospital Inpatient and Observation Care
services and the updates to the code descriptors. Commenters noted that
the descriptor revisions, which will allow practitioners to bill by
time or MDM, will simplify the documentation requirements for these
codes and reduce administrative burden for practitioners. These
commenters also maintained that the change allowing visit level
selection using time or MDM will promote consistency across E/M code
families, as these changes parallel the recent changes to the O/O E/M
visit codes (specifically, allowing visits to be selected based on time
or MDM, and eliminating the requirements that a certain number of
``components'' must be completed). Several commenters specifically
indicated that they found the revisions to the O/O E/M descriptors in
CY 2021 to be positive in terms of reducing administrative burden, and
supported similar changes to the Hospital Inpatient and Observation
Care descriptors. Several commenters noted it may reduce situations in
which practitioners and their coders must distinguish between hospital
inpatient and observation status for correct billing.
However, one commenter raised concerns about the proposed changes
to the Hospital Inpatient and Observation Care descriptors,
particularly that the level of visit will be based on time or MDM only.
The commenter expressed concern that the new guidelines will discourage
physicians from performing a comprehensive history and physical exam.
The commenter suggested that hospital quality issues could arise if E/M
documentation does not include the information needed for billing
services under the Inpatient Prospective Payment System or document
information in accordance with hospital Conditions of Participation
(such as 42 CFR 482.22(c)(5)(i), which requires completion and
documentation of a history and physical exam for each hospital patient
within a specified timeframe of admission).
Response: We appreciate commenters' feedback. We refer readers to
the discussion of our multi-year effort with the American Medical
Association (AMA) and other interested parties to update coding and
payment for evaluation and management (E/M) visits in section II.F.1.
above. We note that, per the new CPT code descriptors, a medically
appropriate history and/or examination will be required, but will no
longer be used to select visit level. We do not believe the revised CPT
descriptors are in conflict with hospital documentation requirements
outside of the PFS. Practitioners working in hospitals should continue
to be aware of the documentation needed to meet requirements for other
payment systems or CoPs, in addition to the documentation required to
bill Hospital Inpatient and Observation Care codes under the PFS.
Comment: While not opposing our proposal to adopt the consolidation
of the two code families, two commenters requested a delay in
implementation of the revised coding. One commenter requested a 90-day
delay in implementation to allow for updates to their electronic
billing system (to update both the time changes in the descriptors and
the removal of the observation code set.). Similarly, another commenter
expressed concern about the overall ability of emergency physician
practices to adapt to E/M changes for CY 2023, specifically changes to
documentation guidelines and, restructured observation care codes, and
a continued discrepancy between CPT and PFS coding for critical care
services that took effect in CY 2022. This commenter was also concerned
about hospital staffing shortages impacting implementation of changes
to the observation codes. This commenter stated that many changes to
the observation codes and billing rules are complicated and will take
time to fully incorporate into workflows; and that CMS should consider
delaying or phasing in some of the changes to the observation codes and
billing requirements.
Response: We appreciate commenters' feedback. CPT has finalized its
consolidation of and changes to the Hospital Inpatient and Observation
Care code families effective January 1, 2023. This means, effective
January 1, 2023, the observation care codes (CPT codes 99217-99220 and
99224-99227) will no longer be valid, and the revised codes (CPT codes
99221-99223, 99231-99236) will be in effect; this is a deadline set by
CPT that CMS cannot influence. If we were to retain the observation
coding or the CY 2022 descriptors even temporarily past January 1,
2023, we would have to create G-codes to replace the deleted or altered
CPT codes. In this instance, creating G-codes would not alleviate
commenters' concerns about having to update electronic billing systems.
In addition, we would have to delay revaluation, since the RUC-
recommended values are based on a survey of the codes as revised by CPT
for CY 2023.
As discussed throughout this section, it is our intention that,
aside from the actual CPT codes selected and the changes to descriptor
times, the billing policies for Hospital Inpatient and Observation Care
will remain largely the same, unless otherwise specified.
Comment: One commenter, while not opposing our proposal to adopt
the revised CPT descriptors for the Hospital Inpatient and Observation
Care codes, expressed dissatisfaction with some aspects of the revised
coding (particularly CPT's guidelines for determining MDM).
Response: We appreciate this commenter's feedback. We proposed to
adopt the CPT guidelines for determining MDM levels, and we understand
that the specialty societies contributed to their revision for 2023
through the AMA Workgroup and CPT processes. Suggestions for additional
revisions can be made to the AMA/CPT, and we will consider any future
changes to the MDM guidelines for future rulemaking.
Comment: One commenter interpreted our proposal to adopt the
consolidation of the Hospital Inpatient and Observation Care code as an
acknowledgment that there is no difference in the physician work or
resources required for patients who have been admitted to a hospital
versus patients seen in observation status. The commenter suggested
that the consolidation of the code families is evidence that we should
discontinue the application of our ``23-hour rule.''
Response: At this time, we do not intend to discontinue our ``23-
hour
[[Page 69591]]
rule'' (which is discussed in greater detail in the CY 2011 PFS final
rule at 75 FR 73226); such consideration would be out of scope for this
section of the rule, which pertains specifically to revisions,
policies, and valuations of the Hospital Inpatient and Observation Care
code sets. However, as discussed further in section II.F.3.b. below, in
light of the consolidation of the Hospital Inpatient and Observation
Care code sets, we will review whether, and if so, how our policies
relating to hospital inpatient and observation services (including the
``23-hour rule'') interact and look forward to further engagement with
the public.
Comment: Several commenters requested clarification of our proposal
to align with the CPT guidance that a continuous service that spans the
transition of 2 calendar dates is a single service and is reported on
the date the service began. The commenters indicated they were unclear
what ``continuous'' means in this context.
Response: We note that this instruction comes from the CPT
Codebook, and we direct commenters to the CPT for additional
clarification, if needed.
After consideration of public comments, we are finalizing the
updates to the Hospital Inpatient and Observation Care code descriptors
and the other policies articulated in this section as proposed.
b. ``8 to 24-Hour Rule'' for Hospital Inpatient or Observation Care
We proposed to retain what is known as the ``8 to 24-hour rule''
regarding payment of admission, discharge, or same-day admission/
discharge codes, depending on the length of stay and whether the
patient was discharged on a different calendar date than they were
admitted (refer to the Medicare Claims Processing Manual, IOM 100-04,
Chapter 12, sections 30.6.8.B and 30.6.9.1.C.). As we discussed in the
CY 2001 PFS final rule (65 FR 65376), the ``8 to 24-hour rule'' was
designed to avoid unintended incentives to keep a patient in the
hospital past midnight during a stay lasting less than 24 hours. When
this policy was memorialized in the CY 2001 PFS final rule, it was
applied to both the initial inpatient hospital care codes (CPT codes
99221 through 99223) and the initial observation care codes (CPT codes
99218 through 99220) which CPT has deleted for 2023. The policy we
proposed at 87 FR 45990 appeared as follows:
If the beneficiary receives less than 8 hours of hospital
inpatient or observation services, the practitioner may not bill for
the same-day admission/discharge codes or hospital inpatient and
observation discharge day management services (to be described by CPT
codes 99234-6 and 99238 and 99239, respectively). If a patient receives
less than 8 hours of hospital inpatient or observation services, we
proposed that the practitioner would bill only initial inpatient or
observation care (described by CPT codes 99221, 99222, or 99223, as
appropriate).
If a beneficiary receives hospital inpatient or
observation services for a minimum of 8 hours but less than 24 hours,
we proposed that the practitioner would bill CPT codes 99234, 99235, or
99236, as appropriate. (These codes, commonly referred to as ``same-day
discharge'' codes, describe hospital inpatient or observation care that
includes both admission and discharge as part of a single service.)
If a beneficiary is admitted for hospital inpatient care
or begins observation and is then discharged after more than 24 hours,
we proposed that the practitioner could bill an initial hospital
inpatient or observation care code (CPT codes 99221 through 99223) for
the date of admission, and a hospital discharge day management service
(CPT code 99238 or 99239) on the date of discharge.
We wish to correct the policy as it was proposed in 87 FR 45990 and
retract the examples we provided illustrating that policy as it
appeared. It was our intention to synthesize the policy (which appears
in several places in the Medicare Claims Processing Manual, as cited
above), and to reiterate that it would remain in effect even after the
consolidation of the Hospital Inpatient and Observation Care codes.
When we summarized the policy, the references to discharge ``on the
same calendar date'' or ``on a different calendar date'' were removed
from parts of the policy in error. We apologize for this confusion.
We intended to retain the billing policy for Hospital Inpatient
codes as it is reflected in the Medicare Claims Processing Manual,
Chapter 12, section 30.6.9.1.C, which states:
``When the patient is admitted to inpatient hospital care for
less than 8 hours on the same date, then Initial Hospital Care, from
CPT code range 99221-99223, shall be reported by the physician. The
Hospital Discharge Day Management service, CPT codes 99238 or 99239,
shall not be reported for this scenario. When a patient is admitted
to inpatient initial hospital care and then discharged on a
different calendar date, the physician shall report an Initial
Hospital Care from CPT code range 99221-99223 and a Hospital
Discharge Day Management service, CPT code 99238 or 99239. When a
patient has been admitted to inpatient hospital care for a minimum
of 8 hours but less than 24 hours and discharged on the same
calendar date, Observation or Inpatient Hospital Care Services
(Including Admission and Discharge Services), from CPT code range
99234-99236, shall be reported.''
We also intended to retain the 8 to 24-hour policy for observation
care, as it is reflected in relevant part in the Medicare Claims
Processing Manual, Chapter 12, section 30.6.8.B:
``When a patient receives observation care for less than 8 hours
on the same calendar date, the Initial Observation Care, from CPT
code range 99218-99220, shall be reported by the physician. The
Observation Care Discharge Service, CPT code 99217, shall not be
reported for this scenario. When a patient is admitted for
observation care and then is discharged on a different calendar
date, the physician shall report Initial Observation Care, from CPT
code range 99218-99220, and CPT observation care discharge CPT code
99217 . . . . When a patient receives observation care for a minimum
of 8 hours, but less than 24 hours, and is discharged on the same
calendar date, Observation or Inpatient Care Services (Including
Admission and Discharge Services) from CPT code range 99234-99236
shall be reported. The observation discharge, CPT code 99217, cannot
also be reported for this scenario.''
We note that the policy for observation care refers to CPT codes
that will no longer be valid effective January 1, 2023. Per the
discussion in section II.3.a., we are adopting the new CPT coding that
consolidates Hospital Inpatient and Observation Care. Thus, we clarify
that we intended to propose that while the policies reflected in the
Medicare Claims Processing Manual (IOM 100-04) at Chapter 12, sections
30.6.8.B. and 30.6.9.1.C), would still apply, both hospital inpatient
and observation care coding should be billed as follows: When a patient
receives hospital inpatient or observation care for less than 8 hours,
only the Initial Hospital Inpatient or Observation Care (CPT codes
99221-99223) shall be reported by the practitioner for the date of
admission.\107\ Hospital or Observation Discharge Day Management (CPT
codes 99238-99239) shall not be reported for this scenario. When a
patient is admitted for hospital inpatient or observation care and then
is discharged on a different calendar date, the practitioner shall
report Initial Hospital Inpatient or Observation Care (CPT codes 99221-
99223) and Hospital
[[Page 69592]]
Inpatient or Observation Discharge Day Management (CPT code 99238 or
99239). When a patient receives hospital inpatient or observation care
for a minimum of 8 hours and is discharged on the same calendar date
(thus the stay is less than 24 hours), Observation or Inpatient Care
Services (Including Admission and Discharge Services) from CPT code
range 99234-99236 shall be reported. CPT codes 99238-99239 cannot also
be reported for this scenario.
---------------------------------------------------------------------------
\107\ We believe this language is a more accurate reflection of
this policy as it appears in 65 FR 65409, which reads, ``If a
patient is admitted as a hospital inpatient or an observation care
patient for less than 8 hours, we will pay for only the admission
service (CPT codes 99221 to 99223 or 99218 to 99220) on that day.
The discharge service is not a separately billable service.''
---------------------------------------------------------------------------
Despite the inadvertent misstatement of the policy in the proposed
rule, our central rationale for wanting to retain the rule remains
intact. We believed it was necessary to retain our ``8 to 24-hour
rule'' to avoid making overpayments, encouraging improper billing of
two E/M visits on the same day, or creating incentives to unnecessarily
extend beneficiaries' hospital stays past midnight. Initial Hospital
Inpatient and Observation Care codes (CPT codes 99221 through 99223 and
99234 through 99239) are billed ``per day,'' and have been valued to
account for all services a practitioner furnishes during the day-long
billing period. In an environment such as a hospital, where admissions
can occur 24 hours a day, relying solely on the calendar date of an
admission or observation stay, to determine a billing day can be
misleading, which is why we proposed to retain the existing ``8 to 24-
hour rule.''
Comment: One commenter expressed support for our proposal to retain
the ``8 to 24-hour rule.'' The commenter questioned, however, whether
there was a possible overlap between the ``8 to 24-hour rule'' and the
``23-hour rule.''
Response: We note that this is a distinct policy from the ``23-hour
rule'' (which is discussed in greater detail in the CY 2011 PFS final
rule at 75 FR 73226). We acknowledge that we have multiple policies
that apply, for different purposes, to services delivered to hospital
inpatients and outpatients. In light of the consolidation of the
Hospital Inpatient and Observation Care code sets, we will begin an
internal review of whether, and if so, how these policies interact; we
welcome further engagement with the public as we consider whether
future rulemaking is needed to reconcile any of our policies.
Comment: Several commenters requested that we consider how the ``8
to 24-hour rule'' interacts with the ``2-midnight rule.'' Specifically,
commenters noted that the ``clocks'' for counting the ``8 to 24-hour
rule'' versus the ``2-midnight rule'' may start running at different
times, which the commenters regard as burdensome.
Response: We note that the ``8 to 24-hour rule'' is distinct from
the ``2-midnight rule'' (which is discussed in the CY 2016 Outpatient
Prospective Payment Schedule final rule at 80 FR 70305). We acknowledge
that we have multiple time-based policies, applicable under different
payment systems, which relate to services delivered to hospital
inpatients and outpatients. In light of the consolidation of the
Hospital Inpatient and Observation Care code sets, we will review how
these policies interact and look forward to further engagement with the
public.
Comment: Several commenters expressed concern either with the ``8
to 24-hour rule'' itself, or with perceived changes to the policy. One
commenter noted, correctly, our current policy which is reflected in
the Medicare Claims Processing Manual, IOM 100-04, Chapter 12, section
30.6.8.B: ``When a patient receives observation care for a minimum of 8
hours but less than 24 hours, and then is discharged on the same
calendar date, Observation or Inpatient Hospital Care Services
(Including Admission and Discharge Services), from CPT code range
99234-99236, shall be reported.'' However, the commenter noted that in
the proposed rule at 87 FR 45990, we stated this policy differently--
namely, that we did not specify that CPT codes 99234-99236 may be
billed if a patient is in the hospital for ``more than 8 hours but less
than 24 hours, and discharged on the same date [emphasis added].''
Commenters were concerned that we were articulating a new requirement
that patients must have been in the hospital for a complete 24 hours
before a Hospital Inpatient or Observation Care Discharge Day
Management code (CPT codes 99238-99239) could be billed.
Several commenters observed that our proposed policy, as written in
87 FR 45990, required that an entire 24-hour period be completed before
being able to bill the same-day admission/discharge CPT codes 99234-
99236 (regardless of whether the 24-hour period spanned one calendar
day or two.) Commenters stated that tracking a complete 24-hour
interval would be difficult for their current recordkeeping systems.
Response: As explained above, it was not our intention to
articulate a new policy, but rather to retain the current policy, and
clarify that it would remain in effect even after the consolidation of
the Hospital Inpatient and Observation Care codes. We also intended to
specify that observation care should be billed according to the new
consolidated CPT coding for hospital inpatient and observation care. In
the policy, as presented in the proposed rule, the references to
discharge either on ``the same calendar date'' or ``a different
calendar date'' were removed in error. We apologize for this confusion.
We hope this clarification addresses the commenters' concerns.
However, given the apparent confusion about the application of the ``8
to 24-hour rule'' in general, we welcome additional public engagement
on this issue as we continue to review the 8 to 24-hour rule and other
billing or resource valuation policies that may affect hospital
inpatient and observation services in light of our adoption of the CPT-
revised single set of codes for inpatient and observation care.
Comment: One commenter raised a concern that the ``8 to 24-hour
rule,'' as proposed, differed from CPT billing guidance, noting that
CPT code selection is based on calendar date and the CMS policy (as
represented in the proposed rule) is based on the time of service. The
commenter stated that they understood the rationale for requiring at
least 8 hours of service to report CPT codes 99234-99236, but did not
agree with the apparent proposal to require that more than 24 hours
must elapse before any code other than CPT codes 99234-99236 may be
billed. The commenter also suggested that the RUC surveys and
valuations for CPT codes 99234-99236 did not contemplate that these
codes would span a mandatory 24-hour interval.
Response: We believe that some of the commenter's concerns may be
alleviated by the clarification of our ``8 to 24-hour rule'' as
discussed in the prior response--namely that CPT codes 99234-99236 may
be billed if a patient receives more than 8 hours of care and is
discharged on the same calendar date; we are not requiring that a full
24 hours must have elapsed.
We note that the difference between our current ``8 to 24-hour
rule'' (as clarified above) and the CPT reporting instructions
effective beginning in 2023 appears to center on how to handle stays
lasting less than 8 hours, and the definition of ``encounter'' (or lack
of a definition) when CPT instructs that same-day admission and
discharge codes may be reported when there is an admission encounter
and a discharge encounter on the same day. (2023 CPT Codebook, p. 17).
We remain concerned that, while unusual, very short hospital stays
crossing a single midnight could be reported inappropriately using two
codes, when the resources expended are better accounted for in one; or
that a same-day admission and discharge code might be inappropriately
reported instead of an initial visit code, where the latter would more
appropriately describe the furnished service. We also
[[Page 69593]]
acknowledge that there may be circumstances in which patients may be in
the hospital for short stays, but still require significant
practitioner time. We believe practitioners may be able to bill the
prolonged HCPCS code G0316 in these circumstances, which is discussed
in section II.F.3.f. and Table 24.
Since the AMA's public comment indicated that they will refer
issues regarding multiple same-day visit billing back to CPT for
review, we recommend that they include these issues in their review. We
will continue to review any future clarifications or reporting
instruction changes that may be made by CPT.
Comment: One commenter requested that we delay enforcement of the 8
to 24-hour rule for one year in light of all of the changes to the
Hospital Inpatient and Observation Care codes.
Response: The ``8 to 24-hour rule,'' itself, is not a new policy,
but we acknowledge the need for ongoing review of this policy in light
of the coding and valuation changes that take effect in 2023 for
hospital inpatient and observation services.
After consideration of public comments received, we are finalizing
our proposal to retain the 8 to 24-hour rule as clarified above. We are
retaining our 8 to 24-hour policy and updating it only to reflect the
consolidation of the Hospital Inpatient and Observation Care code
families. As updated, our final policy is summarized in Table 22.
Table 22--Summary of Final Policy for the ``8 to 24-Hour'' Rule
------------------------------------------------------------------------
Hospital length of stay Discharged on Code(s) to bill
------------------------------------------------------------------------
<8 hours.................... Same calendar date Initial hospital
as admission or services only.*
start of
observation.
8 or more hours............. Same calendar date Same-day admission/
as admission or discharge.*
start of
observation.
<8 hours.................... Different calendar Initial hospital
date than admission services only.*
or start of
observation.
8 or more hours............. Different calendar Initial hospital
date than admission services * +
or start of discharge day
observation. management.
------------------------------------------------------------------------
* Plus prolonged inpatient/observation services, if applicable.
c. Proposed Definition of Initial and Subsequent Hospital Inpatient or
Observation Visit
According to the 2023 CPT Codebook (p. 15), an ``initial'' service
may be reported when ``the patient has not received any professional
services from the physician or other qualified health care professional
or another physician or other qualified health care professional of the
exact same specialty and subspecialty who belongs to the same group
practice during the stay. When advanced practice nurses and physician
assistants are working with physicians they are in the exact same
specialty and subspecialty as the physician.'' The revised CPT codes
99231 through 99233 describe subsequent hospital inpatient or
observation care services similarly. According to the 2023 CPT Codebook
(2023 CPT Codebook, p. 15), a ``subsequent'' service is reported when
the patient has received any professional services from the physician
or other qualified health care professional or another physician or
other qualified health care professional of the exact same specialty
and subspecialty who belongs to the same group practice during the
stay.
As we do not recognize subspecialties, we proposed slightly amended
definitions of ``initial'' and ``subsequent'' service:
An initial service would be defined as one that occurs
when the patient has not received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the same
specialty who belongs to the same group practice during the stay.
A subsequent service would be defined as one that occurs
when the patient has received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the same
specialty who belongs to the same group practice during the stay.
These are the same definitions that we proposed for ``initial'' and
``subsequent'' in the context of nursing facility visits below. We also
proposed that for both initial and subsequent visits, when advanced
practice nurses and physician assistants are working with physicians,
they are always classified in a different specialty than the physician
(please refer to additional discussion in section II.F.2 above).
Comment: One commenter supported our proposed definition of initial
and subsequent visits, noting that, given the large number of
subspecialties, tracking ``initial'' or ``subsequent'' visits based on
subspecialties is cumbersome.
Response: We thank the commenter for their support.
Comment: Several commenters requested that CMS adopt the CPT
definition of ``initial'' and ``subsequent,'' which includes
consideration of subspecialties.
Response: As noted in our discussion above in section II.F.2, we
are continuing to consider whether we could better align our payment
taxonomy with clinical practice, including whether to recognize
subspecialties. At this time, however, we are retaining our current
taxonomy (which does not include recognition of subspecialties) as
described in the Medicare Claims Processing Manual, Pub. 100-04,
Chapter 26, section 10.8, et seq.
Comment: Several commenters requested clarification on how these
definitions would apply when care was provided by NPPs. The commenters
questioned whether care provided by NPPs would be considered as having
been delivered by a different specialty. Several commenters also asked
if we were revising our specialty taxonomy as it pertains to NPPs.
Response: We are not revising our specialty taxonomy for NPPs. As
noted in our discussion above in section II.F.a.2, we are continuing to
consider whether we could better align our payment taxonomy with
clinical practice, including whether (and how) to recognize NPPs as
being in the same specialty as the physician with whom they work. At
this time, however, we are retaining our current taxonomy (which
includes recognition of NPPs as being in their own specialties) as
described in the Medicare Claims Processing Manual, Pub. 100-04,
Chapter 26, section 10.8, et seq.
After consideration of public comments, we are finalizing our
definition of initial and subsequent visits as proposed.
[[Page 69594]]
d. Transitions Between Settings of Care and Multiple Same-Day Visits
for Hospital Patients Furnished by a Single Practitioner
We proposed to retain our current policy that, for the purposes of
reporting an initial hospital inpatient or observation care service, a
transition from observation status to inpatient status does not
constitute a new stay (Medicare Claims Processing Manual, IOM 100-04,
Chapter 12, section 30.6.8.D). For instance, if a practitioner places a
beneficiary in observation status on one date of service (and bills an
initial observation visit to be described under CPT code 99221 through
99223), and then determines later in the stay that the beneficiary
should be admitted to the hospital as an inpatient, the practitioner
would not bill a second initial visit for the hospital inpatient stay.
Rather, the practitioner would bill the work done on the inpatient
admission day as a subsequent visit (CPT codes 99231, 99232, or 99233).
This policy aligns with language in the 2023 CPT Codebook instructions.
(2023 CPT Codebook, p. 16).
We also proposed to retain our policy that, if a patient is seen in
an office setting on one date and receives care at a hospital (for
inpatient or observation care) on the next date from the same
practitioner, both visits are payable to that practitioner, even if
less than 24 hours has elapsed between the visit and the hospital
inpatient or observation care (Medicare Claims Processing Manual, IOM
100-04, Chapter 12, section 30.6.9.1.B). We also proposed, however, to
retain our current policy that, when a patient is admitted to
outpatient observation or as a hospital inpatient via another site of
service (such as, hospital ED, office, nursing facility), all services
provided by the practitioner in conjunction with that admission are
considered part of the initial hospital inpatient or observation care
when performed on the same date as the admission (Medicare Claims
Processing Manual, IOM 100-04, Chapter 12, section 30.6.9.1.A). This
policy differs somewhat from the instructions provided in the 2023 CPT
Codebook (p. 15-16), which allows for payment of both visits on the
same date using Modifier 25.
We believe it is important to retain both policies, as they promote
appropriate payment in situations in which the beneficiary visits the
practitioner in a non-hospital setting, before the practitioner
determines that hospital admission is necessary. The codes for initial
hospital inpatient or observation visits (CPT codes 99221 through
99223) are billed ``per day'' and include all work furnished by the
practitioner on the day of admission. The initial hospital inpatient
and observation care codes do not include work furnished by the
practitioner prior to the date of admission. Thus, under our proposal,
for example, if a practitioner sees a beneficiary in an office setting
at 5 p.m. on April 1st, and the practitioner then admits the
beneficiary to the hospital at 7 a.m. on April 2nd, these would be
separately billable payments, because initial hospital inpatient or
observation care codes (CPT code 99221 through 99223) billed for April
2nd would not retroactively cover the work furnished on April 1st.
However, if the practitioner sees the beneficiary in the office setting
at 7 a.m. on April 1st and then admits the beneficiary at 9 p.m. on
April 1st, all time the practitioner spent furnishing services to that
beneficiary would be reportable under the initial hospital inpatient or
observation care code (CPT code 99221 through 99223).
We also proposed to retain our current billing policy in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, section
30.6.1.A that a practitioner may bill only for an initial hospital or
observation care service if the practitioner sees a patient in the ED
and decides to either place the patient in observation status or admit
the patient as a hospital inpatient. For discussion of additional
policy proposals regarding patients seen in both the ED and the
hospital, refer to section II.F.5. on Emergency Department Services.
We proposed to preserve our current billing policies for patients
in swing beds, which are as follows: If the inpatient care is being
billed by the hospital as inpatient hospital care, the hospital care
codes (CPT codes 99221 through 99223 and 99231 through 99239) apply
(Medicare Claims Processing Manual, IOM 100-04, Chapter 12, section
30.6.9.D). If the inpatient care is being billed by the hospital as
nursing facility care, then the nursing facility codes (CPT codes 99304
through 99316) apply. Please refer to section II.F.6 below on Nursing
Facility Care Services for additional discussion of billing hospital
inpatient or observation care and nursing facility care.
Comment: Several commenters did not support our proposal to retain
the current policy regarding the billing of multiple visits in
different settings by the same practitioner for the same patient on the
same date. Commenters observed that our policy does not align with CPT
guidance on multiple same-day visits. Several commenters also noted
that Medicare billing policy may allow for separate billing of multiple
same-day E/M visits in certain situations.
Response: We note that the policies in this section are
restatements of longstanding policies regarding billing by the same
practitioner for multiple same-day E/M visits furnished to the same
patient. We acknowledge that our policies in some cases differ from CPT
reporting instructions. We also agree that, as noted in several places
in our manual and noted in this rule, there are circumstances in which
we will allow payment for multiple same-day E/M visits. The goal of our
policies is to avoid duplicative payments, where the work involved in
multiple interactions with the same patient on the same day may
overlap. We plan to consider different approaches to this issue in
future rulemaking cycles.
We will be monitoring billing patterns in the claims data, as we
continue to consider these issues. In its public comment, the AMA
indicated that it may refer the issue of multiple same-day visit
billing back to CPT for additional review. We will also review any
future changes that may be made to CPT reporting instructions.
Comment: One commenter noted that, in our discussion of our
proposal at 87 FR 45991 regarding the transition from observation
status to inpatient, we stated, ``For instance, if a practitioner
places a beneficiary in observation status on one date of service (and
bills an initial observation visit to be described under CPT code 99221
through 99223), and then determines later in the stay that the
beneficiary should be admitted to the hospital as an inpatient, the
practitioner would not bill a second initial visit for the hospital
inpatient stay. . . .'' The commenter recommended that we clarify that
in this instance, ``later in the stay'' should refer to ``later in the
day.'' The commenter observed that a practitioner would not be able to
submit two claims (one for the observation care and one for the
hospital care) for care delivered on the same day.
Response: We reiterate that we proposed to align our policy with
the guidance in the 2023 CPT Codebook at p.16, where it says, ``For the
purpose of reporting an initial hospital inpatient or observation care
service, a transition from observation level to inpatient does not
constitute a new stay.'' We agree with the commenter that a
practitioner cannot submit two separate visits for Hospital Inpatient
or Observation Care for care delivered to the same patient on the same
date. However, the practitioner
[[Page 69595]]
can report prolonged inpatient or observation services, as applicable,
if time is used to select visit level.
Comment: One commenter requested clarification of the policy for
physicians who see patients in the ED who are then placed in
observation status.
Response: We thank the commenter for this clarification request.
First, we note that there was a typographical error in our proposed
rule at 87 FR 45991. We had intended to state that we are retaining the
policy in Medicare Claims Processing Manual, IOM 100-04, Chapter 12,
section 30.6.9.1.A (not, as we stated in the proposed rule, section
30.6.1.A). We clarify that we proposed to retain the policy reflected
in section 30.6.9.1.A, which reads, ``A/B MACs (B) pay for an initial
hospital care service if a physician sees a patient in the emergency
room and decides to admit the person to the hospital. They do not pay
for both E/M services. Also, they do not pay for an emergency
department visit by the same physician on the same date of service.''
(We note that where the manual refers to ``physicians,'' the policy
applies to both physicians and qualified NPPs, as appropriate.) In
order to align our billing policies with the consolidated CPT coding
(discussed in section II.3.a.), this policy would apply to hospital
inpatient and observation care billed under CPT codes 99221-99223 and
99231-99236.
Comment: One commenter requested that we review our billing policy
for people transitioning between observation status and NF settings.
Response: We thank the commenter for their feedback. We will
continue to review policies relating to the consolidation of coding for
Hospital Inpatient and Observation Care, and identify policies that may
need further adjustment or clarification in future rulemaking.
After consideration of public comments, we are finalizing the
following policies as proposed in this section:
For the purposes of reporting an initial hospital
inpatient or observation care service, a transition from observation
status to inpatient status does not constitute a new stay.
If a patient is seen in an office setting on one date and
receives care at a hospital (for inpatient or observation care) on the
next date from the same practitioner, both visits are payable to that
practitioner, even if less than 24 hours has elapsed between the office
visit and the hospital inpatient or observation care.
When a patient is admitted to outpatient observation or as
a hospital inpatient via another site of service (such as, hospital ED,
office setting, nursing facility), all services provided by the
practitioner in conjunction with that admission are considered part of
the initial hospital inpatient or observation care when performed on
the same date as the admission. Prolonged time can be counted toward
reporting of prolonged inpatient/observation services (see Table 24).
A practitioner may bill only for an initial hospital or
observation care service if the practitioner sees a patient in the ED
and decides to either place the patient in observation status or admit
the patient as a hospital inpatient.
If the inpatient care is being billed by the hospital as
inpatient hospital care, the hospital care codes (CPT codes 99221
through 99223 and 99231 through 99239) apply. If the inpatient care is
being billed by the hospital as nursing facility care, then the nursing
facility codes (CPT codes 99304 through 99316) apply.
e. Impact of Changes to Hospital Inpatient or Observation Codes on
Billing and Claims Processing Policies
We proposed that, starting in CY 2023, hospital inpatient and
observation care by practitioners will be billed using the same CPT
codes--CPT codes 99221 through 99223, 99231 through 99233, and 99238
and 99239. (We noted that currently, both hospital inpatient and
observation care are already billed under CPT codes 99234 through 99236
for same-day discharge). Therefore, though the current observation care
codes (CPT codes 99218 through 99220 and 99224 through 99226) are being
deleted, practitioners will still be able to furnish and bill for
observation services. We solicited feedback from the public on
potential challenges to billing or claims processing policies for
hospital inpatient or observation care as reflected in the Medicare
Claims Processing Manual (IOM 100-04, Chapter 12), including possible
impact on: billing for patients during a global period (Medicare Claims
Processing Manual, IOM 100-04, Chapter 12, sections 30.6.8.E and
30.6.9.2.A); documentation requirements (Medicare Claims Processing
Manual, IOM 100-04, Chapter 12, sections 30.6.8.C and 30.6.9.1.D);
modifiers associated with hospital inpatient or observation care claims
(Medicare Claims Processing Manual, IOM 100-04, Chapter 12, section
30.6.9.1.F); and any other issues not otherwise discussed in this
proposed rule that may need to be addressed through additional
guidance.
Comment: We received a number of responses to our request for
information about policies potentially impacted by the consolidation of
Hospital Inpatient and Observation Care codes. These comments included
requests for clarification on or review of:
Changes (if any) to place of service (POS) for observation
care claims;
Changes (if any) to billing in circumstances where
practitioners previously would have billed O/O E/M codes; and
Changes (if any) to the use of the AI modifier to identify
the attending practitioner on claims.
We also received a recommendation to create a new POS code for
patients in observation status to aid in reporting and tracking of E/M
services for patients admitted under observation status versus patients
seen in the emergency department.
Response: We thank commenters for their feedback. We will continue
to engage with the public and review our policies in light of the
consolidation of the Hospital Inpatient and Observation Care codes. At
this time, we are not making changes to POS policy (including the POS
that should be placed on a claim for a patient receiving observation
care). We are also not changing policies affecting billing, at this
time, when multiple practitioners furnish E/M services to the same
patient on the same day (such as the policy in Chapter 12 of the
Medicare Claims Processing Manual (IOM 100-04), section 30.6.8.A, which
specifies that while the practitioner who orders the observation care
for a patient may bill for observation care, other practitioners
providing additional evaluations for the patient bill their services as
O/O E/M codes.) We are also not currently making any changes to current
policy on the use of the AI modifier.
We will consider the questions, concerns, and suggestions provided
by commenters in our ongoing review of hospital inpatient and
observation care policy. Absent further clarifications or additional
rulemaking, billing practitioners and providers should continue to
submit claims as they would have prior to the consolidation, though
using the revised CPT codes 99221-99223, 99231-99233, 99238-99239, and
G0316 (as applicable) to reflect observation care services (and unless
otherwise specified in this final rule).
Comment: One commenter requested clarification of guidance in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 4, regarding how
time is counted and reported for HCPCS code G3078 (Hospital observation
service, per hour).
Response: We believe that the commenter's request pertains to
payment made for observation under the
[[Page 69596]]
OPPS, which is outside the scope of this rulemaking as we only address
observation care billed by practitioners under the PFS. We direct
commenters with questions regarding hospital billing or payment to
their MACs for further assistance.
After consideration of public comments, we are finalizing our
proposal that, starting for services furnished in CY 2023, hospital
inpatient and observation care furnished by practitioners will be
billed using CPT codes 99221 through 99223, 99231 through 99233, 99234
through 99236, 99238 and 99239, and G0316 (as applicable). As noted
above, we will also review our billing policies and consider updates as
necessary.
f. Prolonged Services for Hospital Inpatient or Observation Care
As part of its E/M revisions, the CPT Editorial Panel made several
changes to prolonged codes that currently can be billed with inpatient
or observation codes. In its February 2021 meeting, the CPT Editorial
Panel deleted Prolonged Service with Direct Patient Contact (Except
with Office or Other Outpatient Services), including CPT code 99356
(Prolonged service in the inpatient or observation setting, requiring
unit/floor time beyond the usual service; first hour; List separately
in addition to code for inpatient or observation Evaluation and
Management service) and CPT code 99357 (each additional 30 minutes),
effective January 1, 2023. The 2022 CPT Codebook instructions indicate
that CPT codes 99356 and 99357 can be used in conjunction with hospital
inpatient or observation care (CPT codes 99218 through 99236). We refer
readers to instructions on pages 41-42 of the 2022 CPT Codebook, for
example.
To replace deleted CPT codes 99356 and 99357, the CPT Editorial
Panel created CPT code 99418 (Prolonged inpatient or observation
evaluation and management service(s) time with or without direct
patient contact beyond the required time of the primary service when
the primary service level has been selected using total time, each 15
minutes of total time.) (List separately in addition to the code of the
inpatient and observation Evaluation and Management services), which
was referred to in the CY 2023 PFS proposed rule under its placeholder
CPT code 993X0. Additional guidance from the 2023 CPT Codebook states,
``Code 99418 is used to report prolonged total time (that is, combined
time with and without direct patient contact) provided by the physician
or other qualified health care professional on the date of an inpatient
E/M service (that is, CPT codes 99223, 99233, 99236, 99255, 99306,
99310). Prolonged total time is time that is 15 minutes beyond the time
required to report the highest-level primary service.'' (2023 CPT
Codebook, p. 29.)
We did not propose to adopt CPT code 99418, as we believed that the
billing instructions for CPT code 99418 would lead to administrative
complexity, potentially duplicative payments, and limit our ability to
determine how much time was spent with the patient using claims data;
these reasons are discussed in further detail below. We instead
proposed to create a single G-code that describes prolonged inpatient
or observation services, and that could be reported in conjunction with
CPT codes 99223, 99233, and 99236. This G-code would be G0316 (referred
to in the proposed rule as GXXX1):
G0316 Prolonged hospital inpatient or observation care
evaluation and management service(s) beyond the total time for the
primary service (when the primary service has been selected using time
on the date of the primary service); each additional 15 minutes by the
physician or qualified healthcare professional, with or without direct
patient contact (list separately in addition to CPT codes 99223, 99233,
and 99236 for hospital inpatient or observation care evaluation and
management services). (Do not report G0316 on the same date of service
as other prolonged services for evaluation and management 99358, 99359,
99415, 99416, 99418). (Do not report G0316 for any time unit less than
15 minutes).
In parallel to CPT's coding revisions for prolonged inpatient or
observation services, we proposed that the G0316 prolonged code could
only be applied to the highest-level hospital inpatient or observation
care visit codes (CPT codes 99223, 99233, and 99236), and could only be
used when selecting the E/M visit level based on time. In other words,
we proposed that a prolonged code would only be applied once the
greatest amount of time for initial, subsequent, or same-day discharge
visits has been exceeded.
We proposed to use G0316 instead of CPT code 99418 because we
disagreed with the CPT instructions regarding the point in time at
which the prolonged code should apply. According to the 2023 CPT
Codebook, CPT code 99418 which represents a 15-minute interval, would
apply to: CPT code 99223 when a practitioner reaches 90 minutes; CPT
code 99233 when 65 minutes is reached; and CPT code 99236 when 100
minutes is reached. Each of these times represents only 15 minutes more
than the codes' descriptor times. We disagreed with this instruction,
and we believed that a prolonged code should only be applicable after
the total time for the primary service is exceeded (the total time used
or assumed in valuation of the primary service, plus the full 15-
minutes described by the prolonged code).
We noted that CPT code 99236, per the RUC-recommended times,
includes not only 85 minutes of intraservice time (performed on the
date of encounter) but an additional 12 minutes of post-service time.
The RUC based this recommendation on a survey timeframe which was
within 3 days of the date of encounter. We were concerned that the CPT
instructions for CPT code 99418, as it applies to CPT code 99236, would
result in duplicative payment, since the 12-minute post-service time
was factored into the proposed valuation of CPT code 99236. It would be
inappropriate to pay for a prolonged code based on post-service time
that is already accounted for in the base code. We believed that the
instruction for when to apply CPT code 99418 to the primary service CPT
code 99236 would not accurately take into account this post-service
time.
We proposed that the prolonged service period described by G0316
could begin 15 minutes after the total times (as established in the
Physician Time File) for CPT codes 99223, 99233, and 99236 have been
met. Additionally, we proposed that the proposed G0316 prolonged code
would be for a 15-minute increment, and the entire 15-minute increment
must be completed in order to bill G0316. Note that for administrative
simplicity, we proposed to round the time when the prolonged service
period begins to the nearest 5 minutes. For the times below, CPT code
99223, which has a RUC-proposed total time of 74 minutes, would be
treated as though it has 75 total minutes. CPT code 99233, which has a
RUC-proposed total time of 52 minutes, would be treated as though it
has 50 total minutes; and CPT code 99236, which has a RUC-proposed
total time of 97 minutes will be treated as though it has 95 total
minutes. The rounding here is solely for the purpose of calculating a
proposed prolonged period, and would not affect the total times for
these CPT codes in the time file. We note that the time file is
included in the public files provided as part of each year's finalized
PFS, which are posted at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
Thus, a practitioner could bill G0316 for base code CPT code 99223
when 105
[[Page 69597]]
minutes is reached for an initial visit on the date of encounter. For
the purposes of applying the proposed prolonged code, the CPT code
99223 total time is rounded to 75 minutes on the date of encounter. The
prolonged service period would begin at 90 minutes, 15 minutes beyond
75 minutes. A practitioner would bill HCPCS code G0316 once the 15-
minute increment for G0316 is completed, at minute 105.
A practitioner could bill G0316 for the base code CPT code 99233
when 80 minutes is reached for a subsequent visit on the date of
encounter. For the purposes of applying the prolonged code, the CPT
code 99233 total time is rounded to 50 minutes on the date of
encounter. The prolonged service period would begin at 65 minutes, 15
minutes beyond 50 minutes. A practitioner would bill HCPCS code G0316
once the 15-mimute increment for G0316 is completed, at minute 80.
A practitioner could bill HCPCS code G0316 for base code CPT code
99236 at 125 minutes for same-day discharge. For the purposes of
applying the prolonged code, the CPT code 99236 total time is rounded
to 95 minutes completed within 3 calendar days of the encounter. The
prolonged service period would begin at 110 minutes, 15 minutes beyond
95 minutes. A practitioner could bill HCPCS code G0316 once the 15-
minute increment for G0316 is completed, at minute 125.
Refer to summary Table 18 in our proposed rule for a chart showing
the proposed billing timeframe for G0316.
We also proposed that the proposed G0316 would apply to both face-
to-face and non-face-to-face time spent on the patient's care within
the survey timeframe. For CPT codes 99223 and 99233, this would be time
spent on the date of encounter. For CPT code 99236, this would be time
spent on the same date or within 3 subsequent calendar days. Since we
proposed that prolonged services on any date within the service period
(with or without direct patient contact, on the same or different date)
would be reportable under HCPCS code G0318, we also proposed that CPT
codes 99358-9 could not be billed for base codes CPT codes 99221
through 99223 and 99231 through 99236.
This approach was consistent with our final policy for O/O E/M
visits, which requires the use of the prolonged code, G2212 (Prolonged
office or other outpatient evaluation and management service(s) beyond
the maximum required time of the primary procedure which has been
selected using total time on the date of the primary service; each
additional 15 minutes by the physician or qualified healthcare
professional, with or without direct patient contact) for prolonged O/O
E/M services. We continued to be concerned about program integrity,
duplicative payments for time counted in both E/M base codes and
prolonged E/M services codes, the administrative complexity of having
multiple prolonged service codes, and our ability to tell how much time
was spent with the patient using claims data (see our previous
discussion of these issues in our CY 2020 and CY 2021 PFS final rules
at 84 FR 62849 through 62850, and 85 FR 84572 through 84575,
respectively). If we proposed to adopt the CPT codes for prolonged
inpatient and observation E/M visits, we would not be able to identify
the time spent with patients in the claims data alone, because we might
not know which primary service is the companion code to the prolonged
service code(s) due to the wide service timespan (for prolonged
services without direct patient contact) and non-specific care settings
within the prolonged CPT code descriptors.
We received many comments regarding our proposal for Medicare-
specific coding for prolonged Other E/M services. We address comments
that apply across the Other E/M visit families in this final rule in
section II.F.11 below (Prolonged Services). We received a few comments
that apply in isolation to the Inpatient/Observation visit family, and
we address those as follows.
Comment: One commenter questioned how the time was calculated for
the application of G0316. The commenter noted that the revised CPT
descriptors for CPT codes require at least 75 minutes for CPT code
99223, at least 50 minutes for 99233, and at least 85 minutes for
99236. The commenter questioned why G0316 would not apply to the base
codes after an additional 15 minutes beyond the descriptor time had
been reached. In particular, the commenter noted that they were not
able to identify the ``post-service'' time that we applied to the total
time for CPT code 99236, to calculate when G0316 would apply.
Response: We appreciate this commenter's inquiries. We discuss in
section II.F.11 below, and our regulatory impact analysis for
alternatives considered, why we are not choosing to allow reporting of
prolonged services once the minutes of service reach 15 or more minutes
beyond the time in the CPT code descriptor. Specific to G0316, in our
proposed rule (87 FR 45992), we explained that 12 minutes of post-
service time was included in the RUC-recommended total time for CPT
code 99236 (which we are adopting in this final rule). Since the 12
minutes is already accounted for in the valuation for CPT code 99236,
we do not believe it should be counted again toward reporting G0316. We
refer readers to section II.F.11 below for additional discussion of
this issue.
Comment: Several commenters requested clarification that if a
practitioner performs non-face-to-face work on a day prior to a
patient's hospital admission or placement on observation status, this
time cannot be reported by the practitioner using G0316.
Response:. The service times for initial inpatient and observation
care do not include work performed on prior days by the same
practitioner, therefore we are not allowing time on those days to count
toward prolonged services for those services. We refer readers to
section II.F.11 below, where we discuss our rationale for not allowing
practitioners to count time spent on days that were not included in the
surveyed timeframes for Other E/M visits, since such time is not
presumed to be part of the service for purposes of valuation. When the
AMA surveyed practitioners to identify how much work is performed when
furnishing initial inpatient/observation care (measured by how much
time is commonly spent), the survey respondents indicated that they do
not spend time on days prior to the visit for any of the inpatient or
observation care codes. If the same practitioner spends time prior to
the visit as part of another E/M visit in a different setting or as
part of care management services, the prior time can be counted toward
reporting of the prior visit or care management service. (We refer
readers to our PFS Care Management website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management for more information about billing for those services.
Comment: One commenter did not support the use of G0316 only in
instances when the visit level was selected based on time, and believed
that the prolonged code should apply when visits are selected based on
MDM. The commenter suggested that many practitioners do not currently
select the level of visit based on time. The commenter also contended
that, because the G0316 code was based on time, it would contribute to
practitioner burnout by rewarding long hours and would penalize
practitioners for treating patients efficiently.
Response: We note that, as discussed above in section II.F.3.a,
effective January 1, 2023, practitioners will have
[[Page 69598]]
the option of selecting the hospital inpatient or observation care
codes by time or by MDM. We expect that more practitioners may begin
selecting visit based on time as a result of this change. We refer
readers to section II.F.11 below, where we discuss why we believe
prolonged services should not be reportable for services that are not
timed, and the intersection of our Medicare-specific prolonged service
codes with practitioner incentives regarding time spent with patients.
After consideration of public comments, we are finalizing our
proposal to create a new code G0316 for prolonged Hospital Inpatient
and Observation Care services (applicable to primary service CPT codes
99223, 99233, and 99236), as proposed.
g. Valuation of Hospital Inpatient or Observation Care Services
The revised hospital inpatient or observation care codes (CPT codes
99221 through 99223 and 99231 through 99236) were surveyed for the
October 2021 RUC meeting. The survey times captured the total time on
the date of encounter by calendar date. In October 2021, the RUC
referred these services to be resurveyed, because the survey did not
include a request for distinct time before and after floor/unit time,
and therefore, could not be compared to previous RUC surveys of these
services. The RUC reviewed the resurveyed inpatient and observation
services for the January 2022 RUC meeting.
We proposed to accept the RUC recommendations for work RVUs and
times for CPT codes 99221 (work RVU 1.63, intraservice time 40 minutes,
total time 40 minutes); 99222 (work RVU 2.60, intraservice time 55
minutes, total time 55 minutes); 99223 (work RVU of 3.50, intraservice
time 74 minutes, total time 74 minutes); 99231 (work RVU 1.00,
intraservice time 25 minutes, total time 25 minutes), 99232 (work RVU
1.59, intraservice time 36 minutes, total time 36 minutes); 99233 (work
RVU 2.40, intraservice time 52 minutes, total time 52 minutes); 99234
(work RVU 2.00, intraservice time 45 minutes, total time 50 minutes);
99235 (work RVU 3.24, intraservice time 68 minutes, total time 76
minutes); and 99236 (work RVU 4.30, intraservice time 85 minutes, total
time 97 minutes).
There are no PE inputs for these codes.
Comment: Many commenters supported our proposal to accept the RUC-
recommended values for these codes.
Response: We thank commenters for their support.
Comment: Several commenters, although not challenging the RUC
recommendations, voiced general concerns that O/O E/M valuations may
continue to be low, or that any increases in facility-based E/M
services will shift RVUs away from primary care.
Response: We thank the commenters for sharing their concerns. We
will take these concerns into consideration as we continue to examine
valuations for all E/M codes. Please see prior discussions of our
review and revaluation of O/O E/M codes in the CY 2020 final rule (84
FR 62844) and the CY 2021 final rule (85 FR 84548).
Comment: Several commenters opposed the proposed values,
particularly for initial Hospital Inpatient and Observation Care visit
codes (CPT codes 99221-99223), for which we proposed reductions. Some
of these commenters suggested that, to maintain relativity and rank
order, it was important that the initial Hospital Inpatient or
Observation Care codes be assigned higher work RVUs than O/O E/M codes.
Other commenters suggested that the proposed valuations do not
accurately reflect the complexity of hospital inpatient or observation
care. One commenter, echoing concerns about relativity of initial
Hospital Inpatient and Observation Care and new patient O/O E/M visits,
suggested that we review the E/M visit valuations using an expert
panel.
Response: We appreciate commenters' feedback. We disagree with the
commenters that the proposed RVUs for CPT codes 99221-99223 are too
low, especially given the reductions in total time for these codes. We
also continue to disagree with the assertion that facility-based codes
are always inherently (or proportionately) more intense than E/M
services provided in other settings. We reaffirm our discussion of this
issue in section II.F.1.
After consideration of public comments, we are finalizing the RVUs
for CPT codes 99221-9223, 99231-99236 as proposed.
4. Hospital or Observation Discharge Day Management (CPT Codes 99217,
99238 and 99239)
a. Coding Changes to Hospital Inpatient or Observation Discharge Day
Management Services
Effective January 1, 2023, the CPT Editorial Panel deleted the
observation discharge code, CPT code 99217 (Observation care discharge
day management) and revised the two hospital discharge day management
codes, CPT codes 99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less) and CPT code 99239 (more than 30
minutes) so that CPT codes 99238 and 99239 may be billable for
discharge of hospital inpatient or observation patients.
We proposed to adopt the revised CPT codes 99238 and 99239. We also
proposed to retain our current hospital inpatient policy outlined in
the Medicare Claims Processing Manual, Chapter 12, sections 30.6.9.2.B
and 30.6.9.2.E, and expand it to include observation care.
Specifically, we proposed that CPT codes 99238 and 99239 are to be
billed by the practitioner who is personally responsible for discharge
service (or, in the case of the death of the patient, the practitioner
who personally performs the death pronouncement); services furnished by
other practitioners, including: instructions to the patient,
communication with the family/caregiver, and coordination of post
discharge services would be reported as subsequent hospital inpatient
or observation care with CPT codes 99231, 99232, and 99233. (Refer to
the Medicare Claims Processing Manual, IOM 100-04, Chapter 12, Manual,
IOM 100-04, Chapter 12, sections 30.6.9.2.B and 30.6.9.2.E; we note
that we incorrectly cited to 30.6.9.2.A in the proposed rule).
We proposed to retain our related policy that the same practitioner
may not bill a hospital discharge CPT code 99238 or 99239 on the same
day as a subsequent visit CPT codes 99231 through 99233. We refer
readers to the Medicare Claims Processing Manual, IOM 100-04, Chapter
12, section 30.6.9.2.C.
Comment: Several commenters requested clarification on the proposed
policy at 87 FR 45993 (which codifies that the discharge day management
code can only be billed by the practitioner ``personally responsible
for'' the discharge service. Commenters suggested this policy is
difficult to decipher in light of team approaches to care delivery.
Response: We appreciate commenters' feedback. First, we note that
we intended to preserve the policy regarding billing of CPT codes 99238
and 99239, as reflected in the Medicare Claims Processing Manual, IOM
100-04, Chapter 12, section 30.6.9.2.B and 30.6.9.2.E. We intended to
align this policy with both the consolidation of the Hospital Inpatient
and Observation Care code sets and with the 2023 CPT Codebook
guidelines. The 2023 Codebook (p.17) instruction for CPT codes 99238
and 99239 is that, ``Codes 99238, 99239 are to be used by the physician
or other qualified health care
[[Page 69599]]
professional who is responsible for discharge services.'' We note that
our longstanding policy in section 30.6.9.2.B is that only one hospital
discharge day management service is payable per patient per hospital
stay, and this code is billed by the ``attending physician.''
After consideration of public comments, we are finalizing the
adoption of the revised descriptors for CPT codes 99238 and 99239 and
other additional policies in this section as proposed or clarified.
Only one claim for CPT code 99238 or 99239 may be
submitted per patient, per hospital stay. The claim is submitted by the
attending practitioner who is responsible for the discharge service. In
the case of the death of the patient, CPT codes 99238 and 99239 are
billed by the practitioner who personally performs the death
pronouncement.
The same practitioner may not bill both a hospital
discharge CPT code 99238 or 99239 and a subsequent visit CPT codes
99231 through 99233 for the same patient on the same day. (Note also
additional policies affecting the billing of CPT codes 99238 and 99239
discussed in II.F.3.b. above.)
b. Prolonged Services and Hospital Inpatient or Observation Discharge
Day Management
Effective January 1, 2023, the CPT Editorial Panel deleted CPT code
99356 (Prolonged service in the inpatient or observation setting,
requiring unit/floor time beyond the usual service; first hour) and CPT
code 99357 (each additional 30 minutes) and replaced them with CPT code
99418 (Prolonged inpatient or observation evaluation and management
service(s) time with or without direct patient contact beyond the
required time of the primary service when the primary service level has
been selected using total time, each 15 minutes of total time). CPT
codes 99356 and 99357 were not previously billable with discharge day
management CPT codes 99238 or 99239. (Refer to, for example,
instructions on pages 41-42 of the 2022 CPT Codebook.) Additionally,
according to 2023 CPT Codebook instructions (p.29), CPT code 99418
(referred to as CPT code 993X0 in the proposed rule) is not billable
with CPT codes 99238 and 99239.
We proposed that a practitioner would not be able to bill prolonged
services for hospital discharge (CPT codes 99238 or 99239). This means
that CPT codes 99418, 99358-9 (prolonged E/M service on a date other
than the face-to-face E/M, and the proposed G0316 code (discussed in
section II.F.3. of this final rule) would not be payable where the
discharge day management code is CPT codes 99238 or 99239. We believe
the code descriptors for CPT codes 99238 and 99239 do not allow for
additional payment of prolonged services. The descriptor for CPT code
99238 provides for hospital discharge day management, ``30 minutes or
less.'' If a practitioner spends more than 30 minutes on a hospital
discharge service for a patient, the practitioner would be able to bill
CPT code 99239, which is defined in the code descriptor as ``30 minutes
or more.'' Thus, a prolonged code (including CPT codes 99418, 99358,
99359, and our proposed G0316) would not be appropriate for CPT code
99238, because CPT code 99239 accounts for services that exceed 30
minutes.
The descriptor for CPT code 99239 states that the code is for
``more than 30 minutes'' of hospital discharge day management services.
When the RUC surveyed this code, the surveyed timeframe was within 3
calendar days of the encounter. In other words, the descriptor time is
more than 30 minutes, completed within 3 calendar days of the
encounter. Neither the descriptor nor the CPT billing instructions
provide an upper limit on how many minutes can be reported within the
3-day timeframe for CPT code 99239. All face-to-face and non-face-to-
face activities performed by the practitioner during the date of
encounter and within 3 calendar days from the date of encounter may be
counted toward CPT code 99239, as applicable. Prolonged codes CPT codes
99418, 99358, 99359, and our proposed G0316 code are intended to pay
for time not included in the primary E/M codes during the surveyed
timeframe; as it appears that CPT code 99239 already includes all
services furnished during the surveyed timeframe, we do not believe it
is appropriate to allow any prolonged codes to be billed with CPT code
99239 as a base code.
Comment: One commenter noted that in the section of the proposed
rule where this proposal was discussed (87 FR 45993), we misstated the
descriptor for CPT code 99239 as ``30 minutes or more'' when it should
be ``more than 30 minutes.''
Response: We agree with the commenter and thank them for their
attention. We acknowledge our unintentional error.
Comment: One commenter requested clarification on the applicable
timeframe for when time is counted for CPT code 99239--namely whether
the 3-day timeframe described in the proposed rule for the completion
of time refers only to days after discharge, or can include time prior
to discharge.
Response: We clarify that the timeframe is within 3 calendar days
after discharge. We note that time spent providing face-to-face or non-
face-to-face care on a date prior to discharge would be counted toward
an appropriate initial or subsequent Hospital Inpatient or Observation
Care code (CPT codes 99221-99223 or 99231-99233), which are discussed
in section II.F.3.
After consideration of public comments, we are finalizing this
policy as proposed.
c. Valuation of Hospital Inpatient or Observation Discharge Day
Management
The revised discharge day management codes (CPT codes 99238 through
99239) were surveyed for the January 2022 RUC meeting. We proposed to
accept the RUC recommendations for CPT codes 99238 (work RVU 1.50,
intraservice time 28 minutes, total time 38 minutes); and 99239 (work
RVU 2.15, intraservice time 45 minutes, 64 minutes total time).
We proposed the RUC-recommended direct PE inputs for CPT codes
99238 and 99239 without refinement. We received one comment on this
proposal.
Comment: One commenter expressed support for our proposal to accept
the RUC recommendations for this code set.
Response: We thank the commenter for their support.
After consideration of public comments, we are finalizing the RVUs
for CPT codes 99238-99239 as proposed.
5. Emergency Department Visits (CPT Codes 99281-99285)
a. Coding
We have revalued the ED visit codes under the PFS four times: in
1997, 2007, 2020, and most recently in 2021 as part of the update for
O/O E/M visits. In the past, consistent with AMA RUC recommendations,
we revalued these services such that the values of levels 1 through 3
of the ED visits were equal to levels 1 through 3 new patient O/O E/M
visits, and the levels 4 and 5 ED visits were valued higher than the
levels 4 and 5 new patient O/O E/M visits to reflect higher typical
intensity. In addition, in the CY 2018 PFS final rule (82 FR 53018), we
finalized a proposal to nominate all five ED visit codes as potentially
misvalued, based on information suggesting that the work RVUs for ED
visits may not appropriately reflect the full resources involved in
furnishing these services. Specifically, some impacted parties
[[Page 69600]]
expressed concerns that the work RVUs for these services have been
undervalued given the increased acuity of the patient population and
the heterogeneity of the sites, such as freestanding and off-campus
EDs, where ED visits are furnished. Accordingly, the RUC resurveyed and
reviewed these five codes for the April 2018 RUC meeting, and provided
a recommendation to CMS for consideration in CY 2020 rulemaking. In the
CY 2020 PFS final rule (84 FR 62796), we finalized the RUC-recommended
increases to the work RVUs of 0.48 for CPT code 99281, a work RVU of
0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of
2.60 for 99284, and a work RVU of 3.80 for CPT code 99285. The RUC did
not recommend, and we did not finalize, any change in direct PE inputs
for the codes in this family. We noted that the RUC submitted these
recommended values to CMS prior to the submission of the RUC-
recommended revaluation of the O/O E/M visit code family.
In response to our finalizing of the RUC-recommended values for the
ED visits, and to our comment solicitation in the CY 2020 PFS proposed
rule regarding whether we should revalue certain services commensurate
with increases to the O/O E/M visits (84 FR 62859 through 62860), a
commenter submitted a public comment stating that relativity between
the ED visits and O/O E/M visits should be maintained, and submitted a
specific recommendation for CPT codes 99283-99285 that was higher than
the RUC-recommended values. The commenter stated we should preserve the
relationship between the ED and O/O E/M visit code sets that was
established in prior years and that they believe would have likely been
maintained had the O/O E/M visits been reviewed prior to the ED visits.
In order to avoid the rank order anomaly whereby an ED visit would be
valued lower than the analogous O/O E/M visit, we proposed and
eventually finalized the values recommended by this commenter in the CY
2021 PFS final rule (85 FR 84562). This final policy increased the work
RVU from 1.42 to 1.60 for CPT code 99283, from 2.60 to 2.74 for CPT
code 99284, and from 3.80 to 4.00 for CPT code 99285.
Following the implementation of the revisions to the O/O E/M visits
for the CPT 2021 code set, the CPT/RUC Workgroup on E/M standardized
the rest of the E/M sections in the CPT code set. In February 2021, the
CPT Editorial Panel revised the five ED visit codes to align with the
principles included in the E/M office visit services by documenting and
selecting level of service based on medical decision making, effective
January 1, 2023. The descriptor for CPT code 99281 was revised such
that the code may not require the presence of a physician or other
qualified health care professional. The CPT Editorial Panel also
revised the MDM level in the descriptor for CPT code 99282 from ``low''
to ``straightforward'' complexity, and from ``moderate'' to ``low''
complexity for CPT code 99283. These five codes were resurveyed and
reviewed at the April 2021 RUC meeting with recommendations submitted
to CMS for the CY 2023 PFS rulemaking cycle.
We received several comments related to our proposal to adopt the
CPT revisions to the MDM guidelines for the ED visits. Below is a
summary of the comments received and our responses.
Comment: Several commenters raised concerns related to the proposed
changes to the MDM guidelines. Their concerns were that considerable
training and education will be required to ensure clinicians are
prepared to appropriately code their encounters, and that CMS should
consider delaying implementation of the new MDM guidelines in order to
ensure proper education and training can occur. Other commenters noted
that the MDM guidelines do not reflect the level of MDM visits
appropriately for the ED visits using MDM, and they will be applying to
CPT for changes to the MDM guidelines for 2024. Some commenters
requested a delay and recommended to retain the MDM guidelines in their
current form until the AMA reviews the need for additional changes.
Other commenters were supportive of CMS's collaboration with AMA CPT
and the revisions made.
One commenter raised an issue with the current MDM guidelines for
ED visits, involving a local MAC's interpretation and application of
the term ``workup.''
Response: We appreciate the commenters' feedback. It is our
understanding that the AMA E/M workgroup revised the MDM guidelines for
CY 2023 to reflect changes specific to ED visits already, and that ED
member physicians already provided input and made changes to these
guidelines. We are unsure of how the issue involving the term
``workup'' would apply under the new MDM guidelines, and we recommend
that interested parties ask CPT to clarify and consider any relevant
revisions that might be needed for 2024. We understand that an ED
specialty society will propose to CPT additional changes to the MDM
guidelines that would impact ED visit level selection beginning in
2024, if passed by CPT. We will consider additional changes if they are
made by CPT, but we believe we should adopt the changes that have been
made to date for 2023, since they already reflect an initial round of
input from ED physicians in the AMA Workgroup, and a consensus that was
reached at CPT. We will watch for additional changes recommended by
CPT, and may consider any further changes in future rulemaking.
Comment: One commenter agreed with our proposal to adopt the CPT
framework for ED visits, whereby ED visit level would be based on MDM
rather than time.
Response: We thank the commenter for their support.
Comment: One commenter requested clarification on CPT code 99281,
and whether the proposed guideline is intended for professional
services billing by the practitioner in charge of oversight of care, or
is the new code for hospital billing only.
Response: The level 1 ED visit (CPT code 99281) currently describes
services by a physician or qualified health care professional (QHP),
requiring a problem-focused exam and straightforward MDM, among other
physician/QHP work. For 2023, this code is revised to describe an ED
visit for the E/M of a patient that may not require the presence of a
physician or other QHP. The purpose of this CPT code revision, as we
understand it, was to create a more parallel structure between ED and
O/O visits, since as of CY 2021, level 1 O/O visits may not require the
presence of a physician/QHP. An example in the ED setting might be a
patient presenting for suture removal for a laceration repair that was
performed by another provider in a different location, where the wound
is healing well. We are maintaining the active payment status for CPT
code 99281, and we will be monitoring claims data to assess billing
patterns for this and other E/M visits under the new framework.
b. Sites of Service and Multiple Same-Day E/M Visits for Emergency
Department Patients
As we discussed in the previous section (Hospital Inpatient or
Observation Care (CPT codes 99218-99236)) the CPT Editorial Panel has
revised CPT codes 99221 through 99223 to include both inpatient
hospital and observation care services. (Note our proposal in that
section regarding billing policy for transitions between ED and
hospital inpatient or observation care.) We also proposed to modify our
policy regarding when to bill ED codes
[[Page 69601]]
CPT codes or hospital inpatient care (CPT codes 99221 through 99223),
as further described in the Medicare Claims Processing Manual, IOM 100-
04, Chapter 12, 30.6.11.E., to clarify that these policies apply to
observation care billed under CPT codes 99221 through 99223 as well. We
proposed that, if a physician advises their own patient to go to an ED
of a hospital for inpatient care or observation and the physician
subsequently is asked by the ED physician to come to the hospital to
evaluate the patient and to advise the ED physician as to whether the
patient should be admitted to the hospital, placed in observation
status, or sent home, the physicians should bill as follows:
If the patient is admitted to the hospital or placed in
observation status by the patient's personal physician, then the
patient's personal physician should bill only the appropriate level of
the initial hospital inpatient or observation care (CPT codes 99221--
99223), because all E/M services provided by that physician in
conjunction with that admission are considered part of the initial
hospital inpatient or observation care when performed on the same date
as the admission. The ED physician who saw the patient in the ED should
bill the appropriate level of the ED codes.
If the ED physician, based on the advice of the patient's
personal physician who came to the ED to see the patient, sends the
patient home, then the ED physician shall bill the appropriate level of
ED service. The patient's personal physician shall also bill the level
of ED code that describes the service they provided in the ED. If the
patient's personal physician does not come to the hospital to see the
patient, but only advises the ED physician by telephone, then the
patient's personal physician may not bill the ED codes.
Similarly, we proposed that if the ED physician requests that
another physician evaluate a given patient, the other physician should
bill an ED visit code. We also proposed that if the patient is admitted
by the second physician performing the evaluation, that physician shall
bill an initial hospital inpatient or observation care code (CPT codes
99221 through 99223, as appropriate), and not an ED visit code. This
policy appears in the Medicare Claims Processing Manual, (Pub. L. 100-
04, Chapter 12, section 30.6.11.F), and we are clarifying that this
policy applies to both hospital inpatient and observation care billed
under CPT codes 99221 through 99223.
Finally, we noted that the 2023 CPT Codebook provides instructions
that critical care and ED services may be billed on the same day under
certain circumstances. We referred readers to the CY 2022 PFS final
rule (86 FR 65163), where we finalized our policy that critical care
and ED visits may be billed on the same day if performed by the same
physician, or by physicians in the same group and specialty if there is
documentation that the E/M service was provided prior to the critical
care service at a time when the patient did not require critical care,
that the service is medically necessary, and that the service is
separate and distinct, with no duplicative elements from the critical
care service provided later in the day, and that practitioners may bill
for both services. Practitioners must use modifier -25 on the claim
when reporting these critical care services. This policy is also in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.12.6.
Please refer to the next section, ``Nursing Facility Services''
(section II.F.6) for discussion of policies regarding patients seen in
the ED and the nursing facility on the same day.
We received comments specific to the ED to nursing facility
transition. Please refer to the nursing facility section below (section
II.F.6).
After consideration of public comments, we are finalizing as
proposed and will continue to consider for possible future rulemaking
for these visits.
c. Valuation
We proposed the RUC-recommended work RVU for four of the five codes
in the ED Visits family. We proposed a work RVU of 0.25 for CPT code
99281 (Emergency department visit for the evaluation and management of
a patient, that may not require the presence of a physician or other
qualified health care professional), a work RVU of 0.93 for CPT code
99282 (Emergency department visit for the evaluation and management of
a patient, which requires a medically appropriate history and/or
examination and straightforward medical decision making), a work RVU of
1.60 for CPT code 99283 (Emergency department visit for the evaluation
and management of a patient, which requires a medically appropriate
history and/or examination and low level of medical decision making),
and a work RVU of 4.00 for CPT code 99285 (Emergency department visit
for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making).
We disagreed with the RUC-recommended work RVU of 2.60 for CPT code
99284 (Emergency department visit for the evaluation and management of
a patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making) and we
proposed to maintain the current work RVU of 2.74. The survey conducted
for CPT code 99284 maintained unchanged a work time of 40 minutes, and
the level of medical decision making in the code's descriptor also
remains unchanged at ``moderate'' complexity. Therefore, we continue to
believe that the levels 4 and 5 ED visits are more accurately valued
higher than the levels 4 and 5 new patient O/O E/M visits to reflect
their higher typical intensity. This has been the historic relationship
between these codes, and we previously finalized a proposal in the CY
2021 PFS final rule, increasing the work RVU from 2.60 to 2.74 for CPT
code 99284. Given that there has been no change in the surveyed work
time or level of MDM for this service, we continue to believe that the
work RVU of 2.74 that we finalized in the CY 2021 rule cycle remains
the most accurate valuation for CPT code 99284 (85 FR 84562).
The RUC did not recommend and we did not propose any direct PE
inputs for these five ED visit codes.
Comment: We did not receive any comments in opposition to the
proposed values for this family, except for the level 4 ED visit. Most
commenters expressed their support for the proposed work RVU of 2.74
for CPT code 99284. Commenters stated they appreciated that CMS
continues to recognize that the work RVU for a level 4 ED visit should
be higher than for the corresponding level 4 O/O E/M visit, and that
they supported our proposal to retain the historic relativity between
the new patient O/O outpatient E/M codes and the ED E/M codes.
Response: We appreciate the support for our proposed work RVUs from
the commenters.
Comment: A few commenters disagreed with the proposed work RVU of
2.74 for CPT code 99284 and instead supported the RUC-recommended work
RVU of 2.60. The commenters stated that the RUC agreed that the work
RVU for the ED codes should be equivalent to the office/outpatient
visit codes, based on level of MDM and urged CMS to finalize the RUC
recommendation. Commenters stated that, although CPT codes 99204 and
99284 would share the same work RVU of 2.60 under the RUC's
recommendations, this was appropriate, because they asserted that CPT
code 99284 would have notably higher
[[Page 69602]]
intensity due to its shorter work time of 40 minutes (as compared with
60 minutes for CPT code 99204). Commenters also stated that the
proposed work RVU of 2.74 would create a rank order anomaly within the
family of ED codes, since the intensity of CPT code 99284 would be
higher than the intensity of CPT code 99285. The commenters urged CMS
to finalize the RUC recommendations for all five ED codes, including
the work RVU of 2.60 for CPT code 99284.
Response: We appreciate commenters' feedback. We disagree with the
commenters and continue to believe that CPT code 99284 is more
accurately valued at a higher rate than CPT code 99204 at the proposed
work RVU of 2.74. As we noted in the proposed rule, the survey
conducted for CPT code 99284 maintained--unchanged--a work time of 40
minutes, and the level of medical decision making in the code's
descriptor also remains unchanged at ``moderate'' complexity. We do not
agree that the work RVU of CPT code 99284 should be reduced to match
the work RVU of CPT code 99204, given that the code remains essentially
unchanged. This is especially true, given that this has been the
historic relationship between these codes, and that we previously
finalized a proposal in the CY 2021 PFS final rule to increase the work
RVU from 2.60 to 2.74 for CPT code 99284 specifically so that these
codes would not share the same work RVU.
We also disagree with the commenters that our proposed work RVU of
2.74 creates a rank order anomaly within the ED family. The small
difference in intensity between CPT codes 99284 and 99285 (about 3
percent higher for CPT code 99284) is counterbalanced by the much
longer work time of CPT code 99285. We do not believe that the work RVU
of CPT code 99284 should be deliberately lowered to manipulate the
intensity into a lower value than CPT code 99285. We also note that it
is very common for intensity to be slightly lower for codes with longer
work times, even within families where the code descriptors reflect
more difficult MDM. For example, in the office/outpatient visit code
family, CPT code 99204 has a slightly higher intensity than CPT code
99205. This does not constitute a rank order anomaly within the family
(or serve to justify lowering the work RVU for code 99204); rather, it
is an artifact of the longer work time associated with CPT code 99205
as compared with CPT code 99204. We continue to disagree that intensity
would constitute a rationale for finalizing the RUC's recommended work
RVU of 2.60 for CPT code 99284.
After consideration of public comments, are finalizing the work
RVUs and direct PE inputs for all five codes in the Emergency
Department Visits as proposed.
d. Prolonged Services
We proposed that the prolonged services described by HCPCS codes
G0316, G0317, and G0318 would not be reportable in conjunction with ED
visit codes, because the ED visit codes are not reported based on the
amount of time spent with the patient.
We did not receive any comments specific to this proposal,
therefore we are finalizing as proposed. We refer readers to section
II.F.11 below for a discussion of comments received on prolonged Other
E/M services generally. Our final policy for ED visits is reflected in
summary Table 24 in section II.F.12.e. of this final rule.
6. Nursing Facility Visits (CPT Codes 99304-99318)
a. Coding Overview
The codes in the Nursing Facility (NF) services family are used to
report E/M services primarily to patients in nursing facilities and
skilled nursing facilities. Following the implementation of the
revisions to the O/O E/M visits (CPT codes 99201 through 99215) for the
CPT 2021 code set, the CPT/RUC Workgroup on E/M met to standardize the
rest of the E/M sections in the CPT code set. We have received
valuation recommendations from the AMA RUC for the Nursing Facility
Visit codes (CPT codes 99304 through 99318) following completion of its
survey and revaluation process for these codes. In its April 2021
meeting, the RUC provided us the results of its review, and
recommendations for work RVUs, practice expense inputs, and physician
time (number of minutes) for the revised Nursing Facility Visits E/M
code set. Therefore, we proposed changes in coding and values for the
revised Nursing Facility Visits E/M code set. This code set is
effective beginning in CY 2023, and the proposed values, if finalized,
would go into effect with those codes as of January 1, 2023. In its
February 2021 meeting, the CPT Editorial Panel deleted CPT code 99318,
the annual nursing facility assessment code and revised the remaining
nursing facility code to better align with the principles included in
the E/M office visit services by documenting and selecting level of
service based on total time or MDM. The remaining codes, initial and
subsequent daily visits and nursing facility discharge day management
codes were revised. Similar to what was done for the office visit
codes, for CY 2023, we proposed when total time on the date of
encounter is used to select the appropriate level of a nursing facility
visit service code, both the face-to-face and non-face-to-face time
personally spent by the physician (or other qualified health care
professional that is reporting the office visit) assessing and managing
the patient are summed to select the appropriate code to bill.
Additionally, the codes have new descriptor times, assigned for when
time is used to select visit level (We noted that we did not adopt the
CPT Codebook instructions regarding the application of prolonged codes
to CPT codes 99306 and 99310; see additional discussion under the
subsection ``Prolonged Codes for NF Care'' in this section.). CPT
provides that initial nursing facility care (CPT codes 99304 through
99306) may be used once per admission, per practitioner, regardless of
the length of stay in the NF; and that an initial service can be
reported if the patient has not received any face-to-face professional
services from the physician or other qualified health care professional
or another physician or other qualified health care professional of the
exact same specialty and subspecialty who belongs to the same group
practice during the stay, or if the patient is a new patient as defined
by CPT (2023 CPT Codebook, p.24). However, we proposed an alternative
definition of initial NF visit, consistent with our current policy (see
below).
These nursing facility visits are noted by the RUC to be typically
performed in the skilled nursing facility which requires a higher level
of care than the nursing facility. The survey time captured includes
pre-service time 1 day before the date of encounter, intra-service time
is all the time on the date of encounter, and post-service time is 3
days after the date of encounter. The RUC's recommendations for this
code family are consistent with the 25th percentile of the survey
results and is based on a comparison of the survey codes with the
selected the O/O CPT codes as a crosswalk to the key reference
services.
While we have thoroughly reviewed the times and descriptors for all
the codes in this family, and we proposed to accept the RUC
recommendations as explained below, we noted our concerns regarding
instances of inconsistencies and errors, where the time described in
certain CPT code descriptors does not correctly relate to the time that
would be used to select visit level for the
[[Page 69603]]
Nursing Facility visit (for example, CPT code 99306 and 99310 have the
same times noted in the descriptors, where one is an initial visit and
one is a subsequent visit). In general, the specialty societies and the
RUC have advocated for increasing the work RVUs for the Nursing
Facility visits, as compared to their previous values, regardless of
some of the survey times, on the basis that values for these Nursing
Facility visit codes should be valued the same as the values for the
comparable O/O E/M visits. We considered the survey results, especially
reductions in pre-, intra-, and post-service time, and noted that the
comparison to O/O E/M visits is not accurate. These code families are
incomparable for a few reasons, including, but not limited to: (1) the
two families have a different number/stratification of levels for the
visits, thus a one-to-one crosswalk is not possible; (2) times in the
code descriptors detailing the typical time spent at the patient's
bedside or hospital unit vary significantly; and (3) the patient
populations differ substantially, when considering typical patients who
require nursing facility services versus those in the general
beneficiary community. Additional reasons are laid out in our overview
section above. We do not believe that a comparison of these two code
families can technically be made on a code-by-code basis. However,
given the recent changes to the O/O E/M visit values that we finalized
in the CY 2020 PFS final rule (84 FR 62846) and our interest in
maintaining continuity in the overall code set, we proposed to accept
the RUC recommendations for the work time values and work RVUs for
these Nursing Facility visit codes and solicited public comment on our
concerns for some of the codes as noted below in this section.
We proposed to adopt a number of billing policies reflected in our
current Medicare Claims Processing Manual, Chapter 12, section 30.6.13:
We proposed that the initial comprehensive assessment
required under 42 CFR 483.30(c)(4) shall be billed as an initial NF
care visit (CPT code 99304 through 99306). We proposed that a
practitioner may bill the most appropriate initial nursing facility
care code (CPT codes 99304 through 99306) or subsequent nursing
facility care code (CPT codes 99307 through 99310), if the practitioner
furnishes services that meet the code descriptor requirements, even if
the service is furnished prior to the initial comprehensive assessment
required under Sec. 483.30.
A practitioner who bills an initial NF visit (CPT codes 99304
through 99306) for the initial comprehensive assessment required under
Sec. 483.30(c)(4) may bill subsequent NF visits (CPT codes 99307
through 99310), if the practitioner furnishes medically necessary face-
to-face and non-face-to-face care that meets the requirements in the NF
services code descriptors (CPT codes 99307 through 99310) to the
beneficiary prior to the completion of the initial comprehensive
assessment required under Sec. 483.30. We proposed to allow for an
initial or subsequent NF visit to be furnished and billed by the
appropriate practitioner (physician, physician assistant, nurse
practitioner, or clinical nurse specialist as specified in Sec. 483.30
for the type of visit furnished) regardless of whether the initial
comprehensive assessment was performed.
We proposed to retain our policy to not pay a physician
for an ED visit or an office visit and a comprehensive nursing facility
assessment on the same calendar day, because it would be duplicative
care. If the practitioner saw the patient in the nursing facility once
on a given date, they have performed a lot of the work that is included
in the other visit E/M visits, for example an ED visit. The services
furnished on the same date and provided in sites other than the nursing
facility are already bundled into the initial nursing facility care
code when performed on the same date as the nursing facility admission
by the same physician.
We noted that the Medicare Claims Processing Manual also states
that ED visits provided on the same day as a comprehensive nursing
facility assessment are not paid, regardless of whether the ED and
nursing facility visits are by the same or different practitioners
(Chapter 12, section 30.6.11.D). We proposed to retain this policy as
well. We noted that the 2023 CPT Codebook does not limit the number of
visits that can be billed. We proposed that more than one ED and
nursing facility visit could not be billed if both visits are furnished
by the same practitioner on the same date of service.
We proposed to adopt the 2023 CPT Codebook guidance that,
for reporting initial nursing facility care, transitions between
skilled nursing facility level of care and nursing facility level of
care do not constitute a new stay. (2023 CPT Codebook, p. 24.)
We proposed that an initial service is one that occurs
when the patient has not received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the exact same
specialty who belongs to the same group during the stay. We proposed
that a subsequent service is one that occurs when the patient has
received any professional services from the physician or other
qualified health care professional or another physician or other
qualified health care professional of the exact same specialty who
belongs to the same group during the stay. This is the same definition
that we proposed for ``initial'' and ``subsequent'' in the context of
inpatient and observation services above. According to CPT
instructions, an ``initial'' service may be reported when the patient
has not received any professional services from the physician or other
qualified health care professional or another physician or other
qualified health care professional of the exact same specialty and
subspecialty who belongs to the same group practice during the stay. As
we do not recognize subspecialties, we proposed to apply these slightly
amended definitions of ``initial'' and ``subsequent'' service.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: One commenter requested clarification regarding whether we
intended to retain our current policy, as reflected in the Medicare
Claims Processing Manual, IOM 100-04, Chapter 12, section 30.6.9.2.D,
which allows for payment of the hospital discharge day management code
(CPT codes 99238 or 99239) in addition to a separate nursing facility
admission code when they are billed by the same practitioner with the
same date of service.
Response: Consistent with our proposed retention of our other
policies regarding billing by the same practitioner providing multiple
E/M services to the same patient on the same day, it was our intention
to retain this policy as well. We thank the commenter for bringing this
additional related policy to our attention.
Comment: One commenter asked that we permit billing of an ED E/M
visit on the same day as a NF admission/comprehensive assessment,
whether by the same or another practitioner.
Response: The main goal of our proposed policies in this area was
to maintain our current policy while we continue to consider, for
potential future rulemaking, what our policies should be broadly
regarding multiple, same-day E/M visits. In section 30.6.7.C, Chapter
12 of the Medicare Claims Processing Manual (Pub. 100-04), we state,
``MACs may not pay a physician
[[Page 69604]]
for an emergency department visit or an office visit and a
comprehensive nursing facility assessment on the same day. Bundle E/M
visits on the same date provided in sites other than the nursing
facility into the initial nursing facility care code when performed on
the same date as the nursing facility admission by the same
physician.'' Therefore, we believe payment for a NF initial visit can
be made to a practitioner other than the practitioner who furnished the
ED visit on the same day, and we will retain this policy in 2023. If
the NF initial visit and ED visit are furnished by the same
practitioner on the same day, and time is used to select NF visit
level, the time spent by the practitioner for the ED visit can be
counted toward prolonged NF services (G0317) (see Table 24). We will
continue to consider this issue for potential future rulemaking, if
needed.
After consideration of public comments, we are finalizing the
following, as proposed.
The initial comprehensive assessment required under 42 CFR
483.30(c)(4) will be billed as an initial NF visit (CPT code 99304-
99306). A practitioner may bill the most appropriate initial nursing
facility care code (CPT codes 99304-99306) or subsequent nursing
facility care code (CPT codes 99307-99310), if the practitioner
furnishes services that meet the code descriptor requirements, even if
the service is furnished prior to the required initial comprehensive
assessment.
A given practitioner cannot bill an initial NF visit and
another E/M visit (such as an O/O visit or ED visit) on the same date
of service, for the same patient. However, the time the practitioner
spends furnishing a visit in another setting can be counted toward
reporting prolonged NF services, if requirements for reporting
prolonged NF services are met.
We are adopting the CPT instruction for reporting initial
nursing facility care, which provides that transitions between SNF
level of care and nursing facility level of care do not constitute a
new stay.
An initial service is one that occurs when the patient has
not received any professional services from the physician or other
qualified health care professional or another physician or other
qualified health care professional of the exact same specialty who
belongs to the same group during the stay. A subsequent service is one
that occurs when the patient has received any professional services
from the physician or other qualified health care professional or
another physician or other qualified health care professional of the
exact same specialty who belongs to the same group during the stay.
b. Valuation
For CPT codes 99304 through 99310, we proposed to adopt the RUC-
recommended work RVUs for all of the nursing facility E/M visit codes
given the new times surveyed by the RUC and specialty societies.
Specifically, we proposed a work RVU of 1.50 for CPT code 99304
(Initial nursing facility care, per day, for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and straightforward or low level of medical decision
making. When using total time on the date of the encounter for code
selection, 25 minutes must be met or exceeded.), a work RVU of 2.50 for
CPT code 99305 (Initial nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using total time on the date of the encounter for
code selection, 35 minutes must be met or exceeded.), a work RVU of
3.50 for CPT code 99306 (Initial nursing facility care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.), a work RVU of
0.70 for CPT code 99307 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and straightforward medical
decision making. When using total time on the date of the encounter for
code selection, 10 minutes must be met or exceeded.), a work RVU of
1.30 for CPT code 99308 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using total time on the date of the encounter for
code selection, 15 minutes must be met or exceeded.), a work RVU of
1.92 for CPT code 99309 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using total time on the date of the encounter for
code selection, 30 minutes must be met or exceeded.), and a work RVU of
2.80 for CPT code 99310 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.). We proposed the
RUC-recommended direct PE inputs for all the codes in the family, CPT
codes 99305 through 99310.
While we proposed to accept the RUC recommendations for CPT code
99306, we considered maintaining the current work RVU of 3.06, since
there was no change in the overall time. To support their
recommendation, the RUC cited the survey key reference service, CPT
code 99205 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using time for code selection, 60-74 minutes of total time is
spent on the date of the encounter), which has a much higher time noted
in the descriptor and does not seem to be a valid comparison or support
the increase in value to the RUC survey 25th percentile. There was no
change in time for this service, and the code the RUC used for
comparison has a higher total time. We also requested comment on the
accuracy of the time noted in the descriptor for CPT code 99306. We
noted that it is not clear to us why CPT code 99306, which is an
initial service, would have the same descriptor time and medical
decision making as CPT code 99310 which describes a subsequent visit.
We sought clarification, especially with regard to the similarities
between the code descriptors for these two services (CPT codes 99306
and 99310).
For CPT code 99308, we proposed to accept the RUC recommendations;
however, we considered maintaining the current work RVU of 1.16 given
there was a decrease in the total time for the service and no change in
the descriptor time. We solicited comment regarding the RUC
recommendations that the total time be rounded down to 15 minutes
instead of rounding up to twenty minutes, when using total time on the
date of the encounter for code selection (minutes must be met or
exceeded), and sought clarification on this difference. In light of the
changes made to the O/O E/M visits, however, we proposed the RUC-
recommended work RVU of 1.30 for CPT code 99308, but stated that we
would appreciate comments regarding rounding.
For CPT code 99309, we proposed a work RVU of 1.92. When compared
to CPT code 99214 (Office or other outpatient visit for the evaluation
and management of an established patient,
[[Page 69605]]
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter), we are acknowledging the increase in time required to bill
CPT code 99309. We noted that the descriptor time for CPT code 99309
went up since these codes were last revalued. We are focusing on the
time in the descriptor, and if there is a change in the level of MDM.
In light of recent changes made to the O/O E/M visits, however, we
proposed the RUC-recommended work RVU of 1.92 for CPT code 99309.
Although we proposed to adopt all the RUC-recommended work RVUs and
times for this code family as explained above, we solicited comment
regarding the discrepancies in times, which have implications both for
valuation of individual codes (and for PFS ratesetting in general),
since the intraservice times and total times are used as references for
valuing many other services under the PFS. After reviewing the RUC
recommendations, in conjunction with the revised code descriptors and
documentation guidelines for CPT codes 99304 through 99310, we proposed
to accept the RUC-recommended work and time values for the revised
nursing facility visit codes with the PE refinements noted by the RUC
for CY 2023.
We received public comments on these valuation proposals. The
following is a summary of the comments we received and our responses.
Comment: Most commenters supported and commended CMS for proposing
the RUC-recommended work RVUs for all the nursing facility codes, and
stated that it is important to adopt them in the final rule.
Response: We thank the commenters for their support.
Comment: In their public comment, the AMA addressed the questions
asked by CMS related to the times in the code descriptors for CPT codes
99306 and 99310. The AMA explained that the wording of these code
descriptors was intentional, such that descriptor times and MDM are the
same, and that these codes only differ in their inclusion of the terms
``initial'' versus ``subsequent,'' enabling practitioners to use these
terms to decide which code to bill. Although the intra-service time for
CPT code 99306 was 50 minutes, CPT assigned a descriptor time of 45
minutes (which is the same descriptor time for 99310) to provide a
consistent pattern of time increments, simplifying reporting. This
results in descriptor times for CPT codes 99304, 99305, and 99306 that
are 10 minutes apart (25, 35, and 45 minutes, respectively), providing
an easy incremental pattern for those who are reporting these services
based on time.
Response: We appreciate the AMA's clarification. We note that this
incremental pattern was not applied by CPT to CPT codes 99307 and
99308, and CPT does not appear to consistently apply this approach
within or across E/M visit families, historically or for 2023. For
example, the new descriptor times for home/residence visits are not
separated by identical increments, nor are the parallel 2022
domiciliary codes or the 2023 inpatient/observation visit descriptor
times. To help distinguish initial and subsequent NF visits having high
MDM, and better match the descriptor time to the intraservice time, CPT
could have adopted a descriptor time of 50 minutes for CPT code 99306.
To avoid creating Medicare-specific codes for NF visits, for CY 2023 we
are adopting the CPT code descriptors as revised for CPT codes 99306
and 99310. However, we recommend that CPT revise the descriptor for CPT
code 99306, and clarify the methodology being used to establish CPT
code descriptor times within and across E/M visit families. Applying a
consistent methodology seems important for establishing relativity
within and across families.
Comment: In their public comment, the AMA explained that the
descriptor time for CPT code 99308 was rounded down, from 18 minutes
intraservice time to 15 minutes in the descriptor, to maintain a 15-
minute incremental reporting pattern for time among the subsequent NF
visit codes. As discussed above, we note that CPT does not consistently
apply this approach within or across E/M visit families when
establishing descriptor times, historically or for 2023. Applying a
consistent methodology seems important for establishing relativity
within and across families. We recommend that CPT revise the descriptor
for CPT code 99308 to 20 minutes and clarify the methodology being used
to establish CPT code descriptor times within and across E/M visit
families. To avoid creating Medicare-specific codes for NF visits, for
2023, we are adopting the CPT code descriptor as revised for CPT code
99308.
Regarding valuation for CPT code 99308, the RUC appears to have
recommended the increased work RVU based upon a slightly increased
intraservice time, despite a slight decrease in total time. We note
that the specialty societies had requested an even higher work RVU (the
median), which the RUC did not accept. Since the total time decrease
was small, we are finalizing our proposal to accept the RUC-recommended
work RVU (the survey 25th percentile), which will increase the work RVU
for CPT code 99308 from 1.16 to 1.30.
Comment: MedPAC agreed with the concerns we expressed regarding the
times in the descriptors and the associated RUC-recommended valuations
for this family, and was not in support of the proposal to accept the
RUC recommendations for this code family. MedPAC suggested that the RUC
address these concerns by revising the RVUs or that CMS develop its own
RVUs for these services since nursing facility E/M visit codes are used
as reference codes for valuing many other services in the fee schedule.
MedPAC opined that assigning inaccurate work RVUs to these E/M codes
could, therefore, lead to inaccurate payments--not just for these
services, but also for a variety of other services that are valued in
relation to these visits. MedPAC suggested that CMS ask the RUC to
revisit its valuation of the nursing facility E/M visit codes;
alternatively, CMS could propose its own work RVUs in next year's
proposed rule. In the interim, MedPAC further suggested that CMS should
retain the current RVUs for nursing facility E/M visit codes.
Response: We had considered proposing to maintain the work RVUs for
several of the codes, as stated above for the nursing facility code
set, or alternatively, creating new coding or assigning different work
values to address the concerns we identified for this code set.
However, after reviewing our options and considering the potential
impact on interested parties, including the process through which the
codes would be revalued, we concluded it would be least disruptive to
adopt the revised code set and values as proposed. As discussed above,
we are recommending that the CPT Editorial Panel reconsider the
descriptor times for several of the codes in this family, and apply a
more consistent approach to descriptor times within and across
families. We intend to monitor this code set and will propose any
necessary changes through future rulemaking.
After consideration of public comments, we are finalizing as
proposed, to accept the RUC recommendations for this code family and
adopt the CPT codes as revised. However, we recommend that the CPT
Editorial Panel reconsider the descriptor times for several codes in
this family, and provide more transparency and
[[Page 69606]]
consistency when establishing descriptor times for E/M visits.
c. Prolonged Services
We proposed that prolonged nursing facility services by a physician
or NPP would be reportable using prolonged service HCPCS code G0317,
which would be used to account for additional time spent when the total
time for the NF service (specified in the time file) is exceeded by 15
or more minutes. The long descriptor would be G0317 (Prolonged nursing
facility evaluation and management service(s) beyond the total time for
the primary service (when the primary service has been selected using
time on the date of the primary service); each additional 15 minutes by
the physician or qualified healthcare professional, with or without
direct patient contact (list separately in addition to CPT codes 99306,
99310 for nursing facility evaluation and management services). (Do not
report G0317 on the same date of service as other prolonged services
for evaluation and management 99358, 99359, 99418). (Do not report
G0317 for any time unit less than 15 minutes)). We proposed that the
practitioner would include any prolonged service time spent within the
surveyed timeframe, which includes the day before the visit, the day of
the visit, and up to and including 3 days after the visit (please see
summary Table 18 in our proposed rule). We proposed that prolonged
physician or NPP NF services would be reportable when the total time
(in the physician time file) is exceeded by 15 or more minutes which
would be once 95 minutes are spent for initial NF visits, and once 85
minutes are spent for subsequent NF visits, and for each additional 15
minutes furnished thereafter. Consistent with CPT coding guidance as
indicated below, there would not be any frequency limitation;
therefore, we proposed that physicians and NPPs would be able to bill
G0317 for each additional 15-minute increment of time beyond the total
time for CPT codes 99306 and 99310.
Since G0317 includes time without direct patient contact, there
would no longer be a need to use CPT codes 99358 and 99359 (prolonged
E/M service on a date other than the face-to-face E/M) in conjunction
with NF visits. Therefore, we proposed to change the payment status for
CPT codes 99358 and 99359 to ``I'' (Not valid for Medicare purposes.
Medicare uses another code for reporting of, and payment for, these
services). This is consistent with our final policy for O/O E/M visits,
where prolonged time can no longer be reported using CPT codes 99358
and 99359. We continue to be concerned about program integrity,
counting time that was not included in the surveyed timeframe, and the
administrative complexity of having multiple prolonged service codes
associated with a given primary service (see our previous discussion of
these issues in our CY 2020 PFS final rule at 84 FR 62849 through
62850). As we stated in that rule, many other codes are available to
report prolonged E/M work associated with an E/M visits that occurs
outside of the timeframe included in the visit, such as CCM, TCM, PCM,
behavioral health integration (BHI), and other care management service
codes. We designed these codes to be used to report time spent outside
the direct patient contact (but still in management/consideration of
that given patient's case) on dates other than the E/M visit. While
these care management codes are not identical to the prolonged visit
codes, they can be used to report a number of similar activities.
Additional information about those codes can be found on our PFS Care
Management website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management. We also direct the
reader to section II.E. of this final rule, where we proposed
additional care management service codes for pain management and BHI.
When prolonged nursing facility services are furnished by a
physician or NPP, they would be reportable under HCPCS code G0317. We
believe that allowing practitioners to report CPT code 99418 after the
minimum time requirement for the highest level subsequent visit is met
and then exceeded by at least 15 minutes would result in double-
counting time. As a specific example, CPT code 99310 requires that 45
minutes must be met or exceeded up to 60 minutes. If the reporting
practitioner spent 55 minutes of time, those 55 minutes would be billed
and are included in the services described by CPT code 99310. After 60
minutes has been met, any additional time should be counted toward the
15 minutes required to report the add on CPT code for the prolonged
service. Similar to the policy we finalized in the CY 2020 PFS final
rule for the O/O E/M visits (84 FR 62849), which states that when the
time of the reporting physician or NPP is used to select O/O E/M visit
level, HCPCS code G2212 could be reported when the maximum time for the
level 5 O/O E/M visit is exceeded by at least 15 minutes on the date of
service.
In addition, we noted that the CPT code descriptor for CPT code
99418 does not include nursing facility. Further, the timeframes do not
align for CPT codes 99418, 99358, and 99359. The survey time for CPT
code 99418 is for time on the date of service, and when the nursing
facility visit codes were resurveyed by the RUC, the survey time
included the day before, the day of, and up to and including 3 days
post the date of service. We proposed Medicare-specific coding in order
to avoid duplicative counting of time, administratively simplify
prolonged service coding, and better enable us to determine how much
total time was spent with the patient. If we proposed to merely accept
the CPT prolonged service coding changes, we would not be able to
identify the time spent with patients in the claims data alone. This is
because we might not know which primary service is the companion code
to the prolonged service code(s) due to the wide service timespan (for
prolonged services without direct patient contact) and non-specific
care settings within the prolonged CPT code descriptors. Consistent
with CPT's approach, we proposed that practitioners and NPPs would only
be able to report the prolonged services code for NF (G0317) in
conjunction with the highest level codes in the family (CPT code 99306
and 99310). This would also be consistent with our policy for O/O E/M
visits (see (84 FR 62849).
We received many comments regarding our proposal for Medicare-
specific coding for prolonged Other E/M services. We address comments
that apply across the Other E/M visit families in this final rule in
section II.F.11 below (Prolonged Services).
7. Nursing Facility Discharge Management (CPT Codes 99315-99316)
a. Coding
CPT codes 99315 (Nursing facility discharge day management; 30
minutes or less) and 99316 (Nursing facility discharge day management;
more than 30 minutes) were identified for RUC review in October 2021
and were then postponed so that they could be reviewed at the same time
as the inpatient hospital and observation care codes, in January 2022.
Due to changes in physician work, changes in technology, patient
population, and length of stay, the RUC determined that the nursing
facility discharge services could be reviewed separately from the
inpatient hospital discharge day services.
The nursing facility discharge day management codes are used to
report the total duration of time spent by a physician or other
qualified health care
[[Page 69607]]
professional for the final nursing facility discharge of a patient. The
codes include, as appropriate, final examination of the patient and
discussion of the NF stay, even if the time spent on that date is not
continuous. Instructions are given for continuing care to all relevant
caregivers, as well as for preparation of discharge records,
prescriptions, and referral forms. These services require a face-to-
face encounter, which may be performed on a calendar date prior to the
actual discharge date. The time of the face-to-face encounter performed
on a date prior to the discharge date is counted toward CPT code 99315
and CPT code 99316 and not reported separately.
We proposed to retain our policy that CPT codes 99315 and 99316 (as
appropriate) shall be reported for a face-to-face visit with the
patient provided by the physician or the qualified NPP, which is
required in order to report the SNF/NF discharge day management
service. The NF discharge day management visit shall be reported for
the date of the actual visit by the physician or qualified NPP, even if
the patient is discharged from the facility on a different calendar
date. (Refer to Medicare Claims Processing Manual, IOM 100-04, Chapter
12, 30.6.13.I.) Additionally, we proposed that a physician or qualified
NPP may report CPT codes 99315 or 99316 for a patient who has expired
only if the physician or qualified NPP personally performed the death
pronouncement.
b. Valuation
We proposed the RUC-recommended work RVU of 1.50 for CPT code
99315. We considered maintaining the current work RVU of 1.28 for CPT
code 99315, based on the total time ratio between the current time of
40 minutes and the recommended time established by the survey of 40
minutes. Utilizing our total time ratio methodology this ratio equals
100 percent, and 100 percent of the current work RVU of 1.28, which
indicates there is no change to the physician service and no change in
the physician total time. We believe that, since the two components of
work are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs. In this case, there was no change
in total time. However, maintaining CPT code 99315 at the current value
of a work RVU of 1.28 would cause a rank order anomaly with CPT code
99308. Also, given the remaining NF codes were revised to align with
the principles included in the O/O E/M visit services by documenting
and selecting level of service based on total time or MDM, we concluded
that the increase of the work RVU to 1.50 for CPT code 99315 would be
appropriate.
We proposed the RUC-recommended work RVU of 2.50 for CPT code
99316. We considered proposing a work RVU of 2.22 based on the total
time ratio between the current time of 54 minutes and the recommended
time established by the survey of 63 minutes. When we reviewed CPT code
99316, we found that the recommended work RVU was higher than nearly
all of the other global XXX codes with similar time values, and we do
not believe that this code would have an anomalously high intensity. As
we stated earlier, in light of changes made to the O/O E/M visits and
the changes to include documenting and selecting level of service based
on total time or MDM, we proposed the RUC-recommended work RVU of 2.50
for CPT code 99316. We proposed the RUC-recommended direct PE inputs
for CPT code 99315 and the RUC-recommended direct PE inputs for CPT
code 99316.
Comment: We only received comments in support of the proposed
valuation for CPT codes 99315 and 99316.
Response: We appreciate the support for our proposed work RVUs for
CPT codes 99315 and 99316, and are finalizing as proposed.
c. Prolonged Services
CPT code 99315 and CPT code 99316, the two codes for nursing
facility discharge management, are set up as a base code with an add-on
code with no ceiling of time. Since time on any day can be included
when billing CPT code 99315 or 99316, there is no need for a prolonged
service code for either of these two codes. Allowing for a prolonged
service code for either of these two codes could result in double
counting a physician or NPP's time spent during a nursing facility
discharge, which would not be appropriate. Additionally, CPT code 99418
does not include Nursing Facility in the descriptor. Therefore, we
proposed that prolonged services would not be reportable in conjunction
with CPT codes 99315 and 99316 (NF discharge day management).
The following is a summary of the comments we received on our
proposal and our responses.
Comment: We only received comments in support of our proposal that
prolonged services would not be reportable in conjunction with CPT
codes 99315 and 99316.
Response: We appreciate the support from the commenters and are
finalizing as proposed. We refer readers to section II.F.11 below for a
discussion of comments received on prolonged Other E/M services
generally.
8. Annual Nursing Facility Assessment (CPT Code 99318)
a. Coding
CPT code 99318 (Evaluation and management of a patient involving an
annual nursing facility assessment, which requires these 3 key
components: A detailed interval history; A comprehensive examination;
and Medical decision making that is of low to moderate complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 30 minutes are spent at the bedside and on the
patient's facility floor or unit) was recommended for deletion by CPT
for 2023. In February 2021, the CPT Editorial Panel deleted CPT code
99318 and revised seven nursing facility codes to align with the
principles included in the O/O E/M visits by documenting and selecting
level of service based on total time or MDM.
We proposed to accept CPT's deletion of CPT code 99318. Our
longstanding manual guidance states that an annual nursing facility
assessment visit code may substitute as meeting one of the required
physician visits, as specified in 42 CFR 483.30 (c)(1), if the code
requirements for CPT code 99318 are fully met (Medicare Claims
Processing Manual (Pub. 100-04) Chapter 12, section 30.6.13 (B)). Due
to the longstanding nature of the manual section, we believe some
provisions may be outdated, and it is possible to satisfy this
requirement through other codes. We solicited comment on whether there
is a need to keep this code for Medicare purposes. As we consider
accepting the CPT's deletion of CPT code 99318, we are concerned that
the absence of a similar code could cause an unwarranted increase in
valuation of other services under the PFS, and CMS would not have a
means of tracking how often these visits are occurring. While CPT code
99308, CPT code 99309, and CPT code 99310 could be used to report the
required annual visit, if we were to accept deletion of CPT code 99318,
we believe most of the utilization for that former code would instead
be reported under CPT code 99309, with a RUC-recommended work RVU of
1.92 which is described in the valuation section below.
[[Page 69608]]
b. Valuation
After considering the utilization and the need for the service
described by CPT code 99318, we proposed to accept the CPT's deletion
of CPT code 99318. Given the proposed deletion of CPT code 99318, the
RUC recommends that 10 percent of the CPT code 99318 utilization would
go to CPT code 99308, with a work RVU of 1.16; 85 percent of the
utilization would go to CPT code 99309, with a work RVU of 1.55; and 5
percent of the utilization would go to CPT code 99310, with a work RVU
of 2.35.
The following is a summary of the comments we received on our
proposal and our responses.
Comment: All commenters supported the CPT Editorial Panel decision
to delete CPT code 99318, and stated that the service is reported
sufficiently with other codes.
Response: We appreciate the feedback from the commenters regarding
our proposal to accept the CPT Editorial Panel decision to delete CPT
code 99318 and are finalizing as proposed to accept the CPT's deletion
of CPT code 99318. We are also finalizing our proposal to accept the
RUC-recommended utilization estimates for visits that would have been
reported under this code.
9. Home or Residence Services (CPT Codes 99341, 99342, 99344, 99345,
99347-99350)
a. Coding
Beginning in 2023, the CPT Editorial Panel is merging the two E/M
visit families currently titled ``Domiciliary, Rest Home (eg, Boarding
Home), or Custodial Care Services'' and ``Home Services.'' The new
family will be titled ``Home or Residence Services,'' and the codes in
this family will be used to report ``evaluation and management services
provided in a home or residence. . .[and] when the residence is an
assisted living facility, group home (that is not licensed as an
intermediate care facility for individuals with intellectual
disabilities), custodial care facility, or residential substance abuse
treatment facility. For services in an intermediate care facility for
individuals with intellectual disabilities and services provided in a
psychiatric residential treatment center, see Nursing Facility
Services.'' (2023 CPT Codebook, p.25-26). There are no changes to the
included care settings from each respective family, rather the current
care settings for each of the current families are being included
within the new, merged family.
More specifically, in its February 2021 meeting, effective
beginning in 2023, the CPT Editorial Panel deleted the nine CPT codes
in the Domiciliary, Rest Home (for example, Boarding Home), or
Custodial Care Services code family (CPT codes 99324-99328, and 99334-
99337), and one CPT code in the Home Services family (CPT code 99343),
to merge these services with the eight remaining home visit services.
The eight remaining home services CPT codes (99341, 99342, 99344,
99345, and 99347-99350) were revised to describe Home or Residence
Services to align with the principles of the O/O E/M visit codes by
allowing physicians and NPPs to document and select the level of
service based on total practitioner time or MDM level. These changes
include combining the domiciliary, rest home and custodial care CPT
codes with the home visit CPT codes, resulting in a single family of
CPT codes that describe these types of services. In addition, CPT
revised the descriptors to allow reporting that is based on time or MDM
level--in alignment with the O/O E/M visit CPT codes. We proposed to
accept these coding revisions.
The following is a summary of the comments we received and our
responses.
Comment: The commenters supported our proposal to accept the CPT
coding changes for Home or Residence Services codes.
Response: We appreciate the feedback from the commenters regarding
our proposal, and are finalizing as proposed to adopt the CPT merger of
the home and domiciliary visits into one family, and adopt the CPT
codes as revised for reporting these services.
b. Valuation
The RUC survey time includes pre-service time 3 days before the
date of encounter, intraservice time on the date of encounter, and
post-service time that includes 7 days after the date of encounter.
These eight CPT codes were reviewed at the October 2021 RUC meeting
with recommendations submitted to CMS for the CY 2023 rule cycle. The
RUC recommended the survey 25th percentile value for all CPT codes in
the Home or Residence Services code family, except for CPT code 99350,
for which the RUC recommended the median value. We proposed the RUC-
recommended work RVU for all eight CPT codes in the Home or Residence
Services CPT code family. We proposed a work RVU of 1.00 for CPT code
99341 (Home or residence visit for the evaluation and management of a
new patient, which requires a medically appropriate history and/or
examination and straightforward medical decision making), a work RVU of
1.65 for CPT code 99342 (Home or residence visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and low level of medical decision making), a
work RVU of 2.87 for CPT code 99344 (Home or residence visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making), a work RVU of 3.88 for CPT code 99345 (Home or
residence visit for the evaluation and management of a new patient,
which requires a medically appropriate history and/or examination and
high level of medical decision making), a work RVU of 0.90 for CPT code
99347 (Home or residence visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination straightforward medical decision making), a work RVU
of 1.50 for CPT code 99348 (Home or residence visit for the evaluation
and management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making), a work RVU of 2.44 for CPT code 99349 (Home or
residence visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making), and a work
RVU of 3.60 for CPT code 99350 (Home or residence visit for the
evaluation and management of an established patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making).
We proposed the RUC-recommended direct PE inputs for CPT codes
99345 and 99347-99350 without refinement. For CPT codes 99341 and
99342, we are refining the direct PE inputs by removing supply item
SK062 (patient education booklet). For CPT code 99344, we are refining
the direct PE inputs by removing supply items SK062 (patient education
booklet), SJ053 (swab-pad, alcohol), and SJ061 (tongue depressor). Per
the PE Summary of Recommendations provided by the RUC, CPT codes 99341,
99342, 99344, and 99347 would typically have procedures performed on
the same date of service. For those CPT codes, the RUC stated that they
removed supplies that would be duplicative, such as gloves, alcohol
wipes, booklet, and tongue depressor. However, we found that not all of
these duplicative supplies had been removed from CPT codes
[[Page 69609]]
99341, 99342, and 99344 by the RUC. Therefore, we proposed to remove
these duplicative supplies from CPT codes 99341, 99342, and 99344, and
accept the remaining RUC-recommended direct PE inputs without
refinement.
The following is a summary of the comments we received and our
responses.
Comment: The majority of commenters supported our proposal to
accept the RUC-recommended RVUs for all of the Home or Residence
Services codes.
Response: We appreciate the feedback from the commenters regarding
our proposal.
Comment: A few commenters stated the RVUs for the Home or Residence
Services code family were too low, and fail to adequately account for
travel, addressing social determinants of health, and other
comprehensive care. One commenter suggested that we maintain the
current RVUs for codes 99341, 99344, 99345, 99347, and 99348, for which
the RUC-recommended RVUs decreased, while supporting our proposal to
accept the increased RVUs for codes 99342, 99349, and 99350 recommended
by the RUC. Another commenter suggested that we increase the RVUs for
the entire code family to reflect travel expenses, and expressed
concern that unreimbursed travel will be detrimental to the care
provided to very ill patients and threaten the financial viability of
physician practices that provide home or residence visits.
Response: We continue to believe that the RUC-recommended RVUs are
the appropriate values for CPT codes 99341, 99342, 99344, 99345, and
99347-99350. We appreciate the commenters' remarks, and we acknowledge
the concerns regarding providing patient care and addressing social
determinants of health and other issues during home or residence
visits. Historically, travel costs incurred by the physician or
practitioner are not included in the valuation of E/M codes, since
travel time and/or mileage is not considered a resource involved in
furnishing the service. The RUC survey for the Home or Residence
Services code family did not include information on physician travel or
mileage. Also, the CPT E/M guidelines for selecting the level of home
or residence service, when performed based on time, specifically says
not to count the time spent on travel (2023 CPT Codebook, p. 26).
Therefore, we are finalizing the RUC-recommended work RVUs as proposed.
Comment: One commenter requested that we not refine the direct PE
inputs for codes 99341, 99342, and 99344 as proposed. For CPT codes
99341 and 99342, we proposed removing supply item SK062 (patient
education booklet). For CPT code 99344, we proposed removing supply
items SK062 (patient education booklet), SJ053 (swab-pad, alcohol), and
SJ061 (tongue depressor).
Response: Per the PE Summary of Recommendations provided by the
RUC, CPT codes 99341, 99342, 99344, and 99347 would typically have
procedures performed on the same date of service, which would already
include some of the same supply items. For these CPT codes, the RUC
stated that they had removed the PE inputs for supplies that would be
duplicative with the procedure on the same day, such as gloves, alcohol
wipes, a booklet, and a tongue depressor. Although the RUC did remove
the duplicative supplies for CPT code 99347 from the direct PE inputs
they recommended, we found that the RUC had not removed all of these
duplicative supplies from CPT codes 99341, 99342, and 99344. Therefore,
we proposed to remove these duplicative supplies from the direct PE
inputs for CPT codes 99341, 99342, and 99344. We continue to believe
these supplies are duplicative with a same-day procedure, and are,
therefore, finalizing the direct PE inputs for CPT codes 99341, 99342,
99344, and 99347 as proposed.
After consideration of the public comments, we are finalizing the
work RVU values for the Home or Residence Services code family as
proposed. We are also finalizing the direct PE inputs for these codes
as proposed.
c. Prolonged Services for Home or Residence Services
We proposed that prolonged home or residence services by a
physician or NPP would be reportable using HCPCS code G0318 (Prolonged
home or residence evaluation and management service(s) beyond the total
time for the primary service (when the primary service has been
selected using time on the date of the primary service); each
additional 15 minutes by the physician or qualified healthcare
professional, with or without direct patient contact (list separately
in addition to CPT codes 99345, 99350 for home or residence evaluation
and management services). (Do not report G0318 on the same date of
service as other prolonged services for evaluation and management
99358, 99359, 99417). (Do not report G0318 for any time unit less than
15 minutes)). Code G0318 would be reportable when the total time for
the home or residence visit (specified in the time file) is exceeded by
15 or more minutes. Prolonged services (whether on the same date or
another date within the surveyed timeframe) would be reportable as an
add-on code to CPT codes 99345 or 99350 once the practitioner spends
15+ minutes beyond the total time finalized for the primary service (as
specified in the time file). We would allow the physician or NPP to
include any prolonged service time spent within the surveyed timeframe
for the Home or Residence Services code family, which includes pre-
service time 3 days before the date of encounter, intraservice time on
the date of encounter, and post-service time that includes 7 days after
the date of encounter. This means that for CPT code 99345, assuming we
finalized the RUC-recommended total time of 126 minutes, prolonged
services would be reportable once 141 or more minutes are spent by a
physician or NPP providing the home or residence visit. Likewise, for
CPT code 99350, assuming we finalized the RUC-recommended total time of
97 minutes, prolonged services would be reportable once 112 or more
minutes are spent by a physician or NPP providing the home or residence
visit. See Table 18 in our proposed rule for a table summarizing this
information.
Since we proposed that prolonged services on any date within the
service period (with or without direct patient contact, on the same or
different date) would be reportable under G0318, we also proposed that
CPT code 99358 (Prolonged evaluation and management service before and/
or after direct patient care; first hour), CPT code 99359 (Prolonged
evaluation and management service before and/or after direct patient
care; each additional 30 minutes (List separately in addition to code
for prolonged service)), and CPT code 99417 (Prolonged outpatient
evaluation and management service(s) time with or without direct
patient contact beyond the required time of the primary service when
the primary service level has been selected using total time, each 15
minutes of total time (List separately in addition to the code of the
outpatient Evaluation and Management services)) cannot be billed for
CPT codes 99345 and 99350. We proposed to change the status indicator
for CPT codes 99358 and 99359 to ``I,'' which indicates that these
codes are not valid for Medicare purposes, and that Medicare uses
another code for reporting of, and payment for, these services.
We continued to be concerned about program integrity, duplicative
time, counting time that was not included in the surveyed timeframe,
the administrative complexity of having multiple prolonged service
codes, and our ability to determine how much time was spent with the
patient using claims data. If we proposed to merely accept
[[Page 69610]]
the CPT coding for prolonged home or residence E/M visits, we would not
be able to identify from the claims data the time spent with patients.
This is because we might not know which primary service is the
companion code to the prolonged service code(s) due to the wide service
timespan (for prolonged services without direct patient contact) and
non-specific care settings within the prolonged CPT code descriptors.
See our previous discussion of these issues in our CY 2020 PFS final
rule at 84 FR 62849 through 62850. As we stated in that rule, many
other codes are available to report prolonged E/M work associated with
an E/M visit that occurs outside of the timeframe included in the
visit, such as CCM, TCM, PCM, behavioral health integration (BHI), and
other care management service codes. We designed these codes to be used
to report time spent outside the direct patient contact on dates other
than the E/M visit. While these care management codes are not identical
to the prolonged visit codes, they can be used to report a number of
similar activities. Additional information about the care management
codes can be found on our PFS Care Management web page on the CMS
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management. We also directed readers to
our proposals for additional care management service codes for pain
management and BHI.
We received many comments regarding our proposal for Medicare-
specific coding for prolonged Other E/M services. We address comments
that apply across the Other E/M visit families in this final rule in
section II.F.11 below (Prolonged Services). We received a few comments
that apply specifically to prolonged service codes for home or
residence visits, and we address those as follows.
Comment: A few commenters stated it is unclear whether the time for
prolonged code G0318 must occur on the date of the home or residence
visit, or could be over the span of 3 days prior and 7 days after the
home or residence visit occurs.
Response: The prolonged time can occur on the date of the visit, or
within the 3 days prior or 7 days after the visit date. These 11 days
comprise the service period used by the AMA RUC to develop recommended
values for home or residence visits. See Table 24 for a summary of this
information. We note that for ease of reporting, we are rounding to the
nearest 5 minutes for the time threshold to report G0318, which results
in a lower time by 1 or 2 minutes, shown in Table 24.
Comment: One commenter suggested that we allow code G2211 (Visit
complexity inherent to evaluation and management associated with
medical care services that serve as the continuing focal point for all
needed health care services and/or with medical care services that are
part of ongoing care related to a patient's single, serious condition
or a complex condition. (add-on code, list separately in addition to
office/outpatient evaluation and management visit, new or established))
to be reported with the home or residence visit codes.
Response: Section 113 of the Consolidated Appropriations Act, 2021
delayed Medicare payment for G2211 until at least January 1, 2024. For
further discussion on code G2211, see 2. Overview of Policy Proposals,
in this section above, in this final rule.
After consideration of the public comments, we are finalizing our
proposal to create new code G0318 for a prolonged home or residence
visit. We are also finalizing our proposal to change the status
indicator for prolonged CPT codes 99358 and 99359 to ``I,'' which
indicates that these codes are not valid for Medicare purposes, and
that Medicare uses another code for reporting of, and payment for,
these services.
10. Cognitive Assessment and Care Planning (CPT Code 99483)
a. Coding and Valuation
In February 2021, the CPT Editorial Panel revised CPT code 99483 to
replace ``50 minutes'' from its descriptor with a revised time value
determined by the RUC survey to align with the principles underlying
the O/O E/M CPT codes. The 2023 descriptor time for CPT code 99483 will
be 60 minutes typical time instead of 50 minutes typical time.
Due to the increase in the valuation for O/O E/M visits in the CY
2021 PFS final rule (85 FR 84556), we finalized a proposal to increase
the value of CPT code 99483 from 3.44 to 3.80 work RVUs as a service
that is analogous to the O/O E/M visits, because CPT code 99483
includes a high-level O/O E/M visit. We stated that 99483 includes an
evaluation of a patient's cognitive functioning and requires collecting
pertinent history and current cognitive status, all of which require
MDM of moderate or high complexity. To not create a rank order anomaly
with CPT code 99205 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using time for code selection, 60-74 minutes of
total time is spent on the date of the encounter) we increased 99483 by
using the ratio of the increase between the CY 2020 and CY 2021 values
for 99205 to commensurate with the increase to CPT code 99205.
We did not propose the RUC-recommended work RVU of 3.50, because we
continued to believe that this service is appropriately valued more
highly than the analogous O/O E/M visit code, CPT code 99205. Given
what we viewed as the appropriate rank order among these services, we
did not believe a reduction in work RVU, especially with a ten-minute
increase in physician time, is warranted. In the interest of supporting
access to this service, we instead proposed a slight increase from the
current 3.80 to 3.84 to account for the increase in physician time with
use of a total time ratio: we divided the RUC-recommended total time of
86 by the current total time of 85 and then multiplied the product by
the current work RVU of 3.80 to arrive at 3.84. We proposed the RUC-
recommended PE inputs without refinement.
Comment: Several commenters supported our proposal to increase the
work RVU to account for the increase in physician time.
Response: We appreciate the support for this proposal and are
finalizing as proposed a work RVU of 3.84 for CPT code 99483. We are
finalizing as proposed the RUC-recommended PE inputs without
refinement.
b. Prolonged Services
We proposed that prolonged services would not be reportable in
conjunction with CPT code 99483, because it has a typical time in its
descriptor, which is not necessarily the actual time spent.
Accordingly, we would not know when the prolonged services exceeded the
service time.
Comment: A commenter did not agree with our proposal that prolonged
services codes cannot be reported with cognitive assessment and care
planning services, stating that since the inception of the code,
prolonged services have been allowed, and that if 99483 cannot be
reported as a prolonged service, the practitioner may have incentives
to instead use time and report it as 99205.
Response: Since our final policy for other types of prolonged Other
E/M services allows prolonged services reporting once total time, as
reflected in the time file, is exceeded by the appropriate increment
(not once the CPT code descriptor time is exceeded by
[[Page 69611]]
that increment), we do not believe the presence of a typical time in
the descriptor for CPT code 99483 should prevent reporting of prolonged
Cognitive Impairment Assessment services. We are persuaded that it
would be appropriate for CPT code 99483 to be billable with prolonged
services. We believe this would be consistent with our approach to
other prolonged Other E/M services, which is that prolonged services
can be reported if the physician or NPP spends 15 or more minutes
beyond the total time (as specified in the time file and shown in Table
24).
After consideration of the public comments, we are not finalizing
our proposal that prolonged services would not be reportable in
conjunction with CPT code 99483. Instead, we are finalizing that CPT
code 99483 can be billed with HCPCS code G2212 (prolonged office/
outpatient E/M services) when 15 or more minutes beyond the total time
is spent by the physician or NPP (summarized in Table 24). We are
rounding the total time to the nearest 5 minutes for ease of reporting,
which results in a prolonged services reporting threshold of 100
minutes (1 minute lower than the total time of 101 minutes). Time that
is spent by the physician or NPP on any date within the surveyed
timeframe for CPT code 99483 (within 3 days prior or 7 days after the
date of the in-person visit) may be counted toward the reporting of
prolonged services. Accordingly, we are revising the long descriptor
for G2212 to include reference to CPT code 99483 as a code that can be
listed separately with G2212.
11. Prolonged Services
As discussed in the sections above, we proposed Medicare-specific
coding for prolonged Other E/M services. We proposed three G codes
(G0316, G0317 and G0318) for reporting of prolonged Other E/M services
(one for each Other E/M family for which prolonged services would
apply, namely inpatient/observation visits, nursing facility visits,
and home or residence visits). This would be consistent with our
previously finalized approach to prolonged O/O E/M services. In this
section of our final rule, we address public comments regarding this
proposal that apply across the Other E/M visit code families. We refer
readers to individual sections above for public comments specific to a
given code family.
Comment: Many commenters were disappointed with our proposal to use
Medicare-specific coding for prolonged Other E/M services. Their
overarching concern was potential confusion and administrative burden
resulting from different approaches between Medicare and CPT, and the
potential for variation among payers. Some commenters noted that CPT's
approach, dividing prolonged time into time spent on the date of the
visit (described by one code set) and time spent on another date
(described by another code set), is more intuitive for reporting than
combining all time spent during the service time (as surveyed and
valued) into a single code set as we proposed. Some commenters
suggested that we should not align reported time with surveyed
timeframes, which they assert are relatively inaccessible (other than
the table provided by CMS in the proposed rule). However, some
commenters supported our proposal. These commenters agreed with CMS
that the proposed Medicare-specific coding will avoid duplicative
payment, and corrects a lack of transparency in the CPT reporting times
in comparison to survey times and work valuation.
The AMA stated that it is imperative that physicians have one set
of clear codes and guidelines to report prolonged services. The AMA's
strong preference is for CMS to rely on the CPT codes and guidelines,
and if not, the AMA Workgroup on E/M will reconvene to discuss whether
revisions are needed to the CPT codes and guidelines. The AMA urged CMS
to work with the CPT/RUC E/M Workgroup to bring CMS and CPT prolonged
services policies into alignment. The AMA also expressed interest in
receiving CMS input earlier in its processes, which could improve
alignment with a given CMS rulemaking cycle.
In their public comment, the AMA outlined ways in which they had
sought to align the revised CPT coding with CMS' historical approach to
prolonged services, and avoid creating a global period for E/M visits.
The AMA noted that, during the E/M Workgroup process and CPT processes,
there was much debate about whether to divide total time for reporting
purposes into multiple codes, according to whether the time was spent
on the date of the visit or another date. The E/M Workgroup believed
that total time on the date of the encounter would be simpler to track
and document for the primary service.
The AMA also noted that their recommended valuations for prolonged
service codes are mathematically correct and simpler administratively.
Regarding prolonged services on a date other than the face-to-face
E/M service (CPT codes 99358-9), the AMA recognized the concerns of CMS
and agreed that potential overlap should be eliminated. The AMA also
noted that the other care management services have not eliminated the
need to recognize a substantial amount of work that occurs on single
day. They stated that they expected the volume for CPT codes 99358-9 to
drop substantially, as reporting would no longer be allowed for time on
the date of the encounter. The AMA stated that incorrect reporting
should be addressed, but improper reporting by the few should not lead
to these codes being eliminated. The AMA further stated that the CPT
Editorial Panel may consider revisions to the prolonged service codes,
but requested that CMS be an active participant in the public and open
CPT processes rather than only in CMS rulemaking.
Response: We appreciate the commenters' concerns, and agree that
the ideal approach would be a uniform CPT code set for reporting
prolonged services. Generally, we prefer coding that is clear and
consistent for practitioners to use, and we create Medicare-specific
coding only when there is a significant program integrity concern or
programmatic need, such as tailoring a code to a specific Medicare
statutory benefit category.
Historically, time could only be used to select visit level when
counseling and care coordination comprised more than half of the visit
(See Medicare Claims Processing Manual (Pub. 100-04) Chapter 12,
section 30.6.15.1.H). Prolonged services could be billed in that
situation, only when the time for the highest-level visit in a given
code family was exceeded by the prolonged services time increment.
Prolonged services could also be billed for any visit level if the
typical time was exceeded by the prolonged services time increment.
Until 2017, prolonged services were only separately paid for face-to-
face prolonged service time, which generally occurred on the date of
the visit.
CY 2023 will be the first year in PFS history that almost any E/M
visit level can be selected using time, whether that time was spent on
the same day or another day. Almost all E/M visit codes have new times,
new survey data, new valuations, new parameters for how visit level is
selected, and revised MDM levels. Some of the highest volume code
families will be merged, and a number of code families will have a
different number of levels within the family than previously. It is
hard to contemplate a single aspect of E/M visit coding that will not
change in some way, and these services account for a high share of PFS
spending. Therefore, it is appropriate for us to take a fresh look at
our policy. In recent years, the E/M visit overhaul has
[[Page 69612]]
involved substantial work in a compressed timeframe, and our policy
views have continued to evolve with each rulemaking cycle. We greatly
appreciate and value the opportunity to attend the AMA meetings, but as
a federal agency obligated under the Administrative Procedure Act and
section 1871 of the Act to use notice and comment rulemaking procedures
to establish regulations, and given that we generally use the AMA's CPT
coding and RUC recommendations as the starting point to describe and
value services to meet our statutory mandates for the PFS, it would not
be appropriate for us to participate in AMA processes in a way that
could steer its decisions. Additionally, CMS engages in an extensive
internal deliberative process to develop its proposed and final
policies that are ultimately issued through notice and comment
rulemaking.
We have noted our concerns with the AMA's approach to prolonged
services in several rulemaking cycles. We laid out many concerns with
CPT codes 99358-9 when we adopted them in 2017 as an interim approach,
given that at that time there were not many care management codes to
account for physician time (81 FR 80228 through 80230). We laid out
many more concerns in 2021 when finalizing our policy for prolonged O/O
visits (84 FR 62847 through 62851). Although we initially adopted the
CPT code for prolonged O/O services, we expressed our belief that there
should be a single code for prolonged O/O service reporting, and
subsequently finalized a Medicare-specific code because of our concerns
about duplicative time counting under the revised CPT code (85 FR 84572
through 84575).
Prolonged service codes function like add-on codes for ``extra-
long'' E/M visits. We believe the role of prolonged service codes is to
account for time spent beyond the total service time, which is
established in the AMA RUC survey for the primary service (the code
with which the prolonged service code is billed, such as Level 3 home/
residence visit), and reflected in the primary service's valuation. In
contrast, the AMA seems to view prolonged services as accounting for
time spent beyond intra-service time, which is only part of the visit.
However, the total times recommended and used by the RUC to recommend
values for the primary services, which we review and consider in
establishing values for the PFS, are not limited to intra-service time.
They include pre- and post-service time as well, and as such, the
primary service is already valued to include total time. It would be
redundant to reflect this time under the primary service code, and then
again using prolonged service code(s) in addition to the primary
service code.
We understand that viewing the service as a whole requires the
billing practitioner to look back once the visit is completed to
identify the total time spent furnishing the service, rather than
billing one code at the end of the calendar date of the face-to-face
visit, and another code to reflect additional time spent on other days.
However, we do not see another way to more accurately account for time.
If practitioners want to bill immediately for time spent on the date of
a visit, or during the face-to-face portion of the service, then
perhaps the AMA's surveys (and associated valuation recommendations)
should be limited to that timeframe, instead of including other time.
We do not believe it would be appropriate to adopt a policy suggesting
that a practitioner can bill an extra code that describes time and work
that was already reflected in the survey, valuation, and PFS payment as
part of the pre-/post-service time for the primary visit code.
We laid out a summary table (Table 18 in the proposed rule),
displaying information that we thought would help practitioners who may
not be immediately aware of the surveyed timeframes for E/M visits, and
who may lack familiarity with the AMA process where visits are assumed
to take place over a number of days (and with different timeframes for
different types of visits) and valued accordingly. We anticipate
providing a similar table in our manual, website, and other
subregulatory guidance to facilitate practitioner access to this
information. We do not believe the solution lies in open-ended codes
like CPT codes 99358-9, which have no beginning, end, or specified
setting, seemingly could be used when a visit is not timed, and cannot
readily be associated or connected with a particular face-to-face
visit. Since practitioners may find it easier to follow time thresholds
for reporting that are rounded, we are rounding all of the total times
to the nearest 5 minutes, as reflected in Table 24. (This results in
rounding down the reporting time thresholds for prolonged Other E/M
services by 1 or 2 minutes in several instances).
We appreciate the AMA's understanding of the many issues we laid
out for CPT codes 99358-9, describing prolonged time spent on a date
other than the visit, and planning for additional review. We will
continue to follow any additional developments on these codes and
prolonged service coding generally should the AMA make additional
changes.
Comment: In its public comment, the AMA defended payment for the
15-minute prolonged service code for one minute of service time by
pointing out the conundrum of any time threshold, where small time
increments can result in disproportionate RVU increases when
transitioning between levels of service (for example, from a level 4 to
level 5 O/O visit) where time is being used to select visit level. The
AMA used examples from the O/O visit code set, rather than the Other E/
M visit code set to demonstrate this point.
Response: We appreciate the AMA's feedback. Based on the AMA E/M
Workgroup discussions, we understood that the AMA views prolonged
services as a type of additional visit level, based solely on
additional time. Viewed through that lens, it might be understandable
to allow reporting of the code representing the next highest level, as
soon as the floor of that next level is reached. However, CPT did not
define prolonged services as an additional visit level. Also, we
believe that prolonged services should describe additional time beyond
the total time (not just the intra-service time), since the primary
service is already valued based on total time.
Comment: One commenter recommended requiring a 15-minute time
increment beyond the CPT code descriptor time, which they noted is the
same as CPT's approach.
Response: We appreciate the commenter's feedback. We considered
this approach in our proposed rule (87 FR 46426). However, our
understanding is that the time in the CPT code descriptors for the
Other E/M primary services generally corresponds to the intra-service
time for the primary service. As previously discussed, we believe
prolonged services should be billed to account for time surpassing the
total time rather than just the intra-service time, since pre- and
post-service time is already included in the primary service valuation.
We continue to believe that adopting the CPT codes for prolonged
services would result in duplicative time counting, and reported times
that do not align with work times used for valuation. Having three sets
of codes for reporting time associated with a single visit is overly
complex, and hinders our ability to assess how much time was spent, or
trends in time spent, with patients using claims data under the new
framework. However, we agree with commenters that a uniform code set
for use by all payers for prolonged services is preferable to further
reduce
[[Page 69613]]
administrative burden. After consideration of the public comments, we
are finalizing our proposals for prolonged Other E/M services as
proposed, and we will continue to work with the AMA to consider further
refinements and standardization of this code set through notice and
comment rulemaking. In Table 24, we provide a summary listing of the
required time thresholds to report prolonged Other E/M services
beginning in CY 2023, and show the time periods during which
practitioners may count time spent toward prolonged service reporting.
12. Prolonged Services Valuation
a. Prolonged Services With Direct Patient Contact (CPT Codes 99354-
99357)
The CPT Editorial Panel is deleting CPT codes 99354-99357
(prolonged services with direct patient contact (except with office or
other outpatient services)). These codes are currently used to report
prolonged E/M visit time involving direct patient contact by physicians
or NPPs beyond the usual service in settings other than O/O settings.
We proposed to accept this deletion, since this work would be reported
instead under the Medicare-specific codes that we proposed for
prolonged physician/NPP time, discussed in each family's section above.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed.
b. Prolonged Services on a Different Date Than the E/M (CPT Codes
99358-99359)
We noted that the RUC resurveyed and provided recommendations to
revalue these codes. However, we proposed to assign an inactive status
to these codes for purposes of Medicare payment as discussed above. We
received comments on this proposal, which we discuss above as
applicable within each family.
After consideration of the public comments, we are finalizing as
proposed to assign an inactive status to these codes for purposes of
PFS payment as discussed above.
c. Prolonged Clinical Staff Services (CPT Codes 99415 and 99416)
CPT code 99415 was created to describe the first hour of prolonged
clinical staff services provided in addition to an office E/M visit,
while CPT code 99416 was created to describe each additional 30 minutes
beyond that first hour of prolonged clinical staff service time that
was provided in addition to the O/O E/M visit. For these codes, we
proposed the RUC-recommended direct PE inputs without refinement.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed.
d. Valuation of Prolonged Other E/M Services (HCPCS Codes G0316, G0317
and G0318)
As discussed above in the Overview section, we do not agree that
there is necessarily inherently greater complexity of patient need or
intensity of work for E/M visits furnished in non-office settings (for
example, inpatient, ED, and home settings) compared to the office
settings. Therefore, we believe it would be more accurate to make
payment based on the same time increment of physician work in these
various settings. We proposed that the three prolonged visit HCPCS G
codes G0316-G0318 (discussed above under each applicable family) be
valued identically across settings, based on the RUC-recommended value
for CPT code 99417. Therefore, we proposed a work RVU of 0.61 for these
codes with a crosswalk to CPT code 99417. We likewise proposed direct
PE inputs for these three codes that are identical to the RUC-
recommended PE inputs for CPT code 99417 (prolonged office/outpatient
services). For the purposes of ratesetting, our utilization for these
services included the assumption that one third of the services
currently reported with 99356 would be reported with each of HCPCS
codes G0316, G0317, and G0318, and one third of the services currently
reported with 99357 would be reported with each of HCPCS codes G0316,
G0317, and G0318. We would continue to use HCPCS code G2212 as
previously finalized in lieu of CPT code 99417.
Comment: The AMA stated that our approach to prolonged services
would result overall in a decreased valuation for prolonged services,
compared to their historical valuation. They noted this runs contrary
to our original goal of shortening the prolonged service period, in
order to increase prolonged services reporting (see 83 FR 35773,
59580).
Response: We appreciate this concern. Given the many changing
aspects of E/M visit coding and payment, it does not seem feasible to
estimate how prolonged services reporting and payment may change in
2023 compared to historical levels, and how this might impact the
amount of time spent with patients. One of our key considerations in
redesigning the prolonged services code set is whether we will be able
to see more clearly how much time is spent with patients through claims
data. We note that practitioners will be allowed to count time spent on
visit documentation (documenting clinical information), which will help
them reach reporting thresholds based on time earlier than they could
historically. Regarding valuation compared to historical levels, the
Medicare-specific coding has comparable or higher work per unit of time
(see Table 23). We will monitor the claims data for prolonged services,
and potentially consider future rulemaking if we observe under-
reporting of prolonged services.
[GRAPHIC] [TIFF OMITTED] TR18NO22.050
[[Page 69614]]
Comment: A commenter did not support the establishment of HCPCS
codes G0316, G0317, and G0318, saying that this approach and our
proposed work RVU of 0.61 for these G codes, inappropriately modifies
the relativity between the prolonged visit codes and other services
under the PFS. A commenter urged us to implement prolonged nursing
facility and home/residence visits using CPT codes 99418 and 99417, and
to adopt the RUC-recommended work RVUs of 0.81 and 0.61 respectively.
Response: As discussed in this final rule in section II.F.11 above
(Prolonged Services), we do not agree that there is necessarily
inherently greater service complexity or intensity of work for E/M
visits furnished in non-office settings (for example, inpatient, ED,
and home settings) compared to the office settings. We are finalizing
as proposed HCPCS codes G0316, G0317, and G0318 with a work RVU of 0.61
and direct PE inputs for these three codes that are identical to the
RUC-recommended PE inputs for CPT code 99417.
e. Summary of Required Time Thresholds To Report Other E/M Prolonged
Services
Table 24 summarizes the final rules for reporting Other E/M
prolonged services by physicians or NPPs (See each family section above
for detailed information).
[GRAPHIC] [TIFF OMITTED] TR18NO22.051
13. Consultations (CPT Codes 99241-99255)
The RUC revised the code descriptors, deleted two codes, and
revalued the RVUs of the consultation codes during its October 2021 and
January 2022 RUC meetings. We did not review the RUC recommendations
for the eight revised consultation codes (CPT codes 99242, 99243,
99244, 99245, 99252, 99253, 99254, and 99255). In our proposed rule, we
noted that CMS stopped paying for the consultation codes beginning in
CY 2010. We refer readers to 74 FR 61767 through 61775, where we
discuss our payment policy for these services.
14. Payment for Multiple Same-Day Visits
Our manuals include many longstanding policies regarding when more
than one Other E/M visit can be billed by the same practitioner for the
same patient on the same date of service, particularly when a patient
is being transferred among multiple care settings. In contrast, CPT
code reporting instructions generally do not limit the number of visits
that can be billed. We proposed to continue our longstanding policies
for same-day visits, and refer the reader to the sections above
regarding our final policies in application to each individual Other E/
M family.
15. Split (or Shared) Services
The split (or shared) ``substantive portion'' policy for services
furnished in facility settings was reflected in subregulatory guidance
until it was withdrawn in May of 2021, in response to a petition under
the Good Guidance regulation. In the CY 2022 PFS final rule (86 FR
65150 through 65159), we finalized a policy for E/M visits furnished in
a facility setting, to allow payment to a physician for a split (or
shared) visit (including prolonged visits), where a physician and NPP
provide the service together (not necessarily concurrently), and the
billing physician personally performs a substantive portion of the
visit. At that time, commenters were generally supportive of our
approach, with some divide with regard to our definition of substantive
portion. Some commenters preferred the use of MDM or one of the three
key visit components as opposed to time for purposes of defining what
is the substantive portion of the service.
[[Page 69615]]
a. Background
A split (or shared) visit refers to an E/M visit performed by both
a physician and an NPP in the same group practice. In the non-facility
(for example, office) setting, the rules for ``incident to'' billing
apply under this circumstance. However, ``incident to'' services are
not available for services furnished in a facility setting.
Longstanding CMS policy has been that, for split (or shared) visits in
the facility (for example, hospital) setting, the physician can bill
for the services if they perform a substantive portion of the
encounter. Section 1833(a)(1)(N) of the Act specifies that payment is
made for services furnished and billed by a physician at the PFS rate,
while under section 1833(a)(1)(O)(i) of the Act, NPPs are paid for the
services they furnish and bill for at a reduced PFS rate (85 percent of
the PFS).
We defined substantive portion in the CY 2022 PFS final rule (86 FR
65152 through 65156) and provided for billing of split (or shared)
visits in certain settings (86 FR 65156 through 65157) and for certain
patient types (new and established) (86 FR 65156). After consideration
of the public comments on the CY 2022 PFS proposed rule, we finalized a
phased in approach to this policy (86 FR 65153). For CY 2022, we
finalized the definition of substantive portion as one of the
following: history, or exam, or MDM, or more than half of total time.
In the CY 2022 PFS final rule (86 FR 65152 and 65153), we finalized
that for CY 2023, the definition of substantive portion is more than
half of total time.
As part of our ongoing engagement with interested parties, we are
hearing continued concern about the implementation of our phased in
approach with regard to defining ``substantive portion'' only as more
than half of the total time of the visit, and continue to receive
requests that we also recognize MDM as the substantive portion. Many of
these concerns relate to practice patterns where the physician does not
spend half or more of the time with the patient, as well as possible
adjustments needed to the practice's internal processes or information
systems used to track visits based on time, rather than MDM. After
consideration of public feedback, we proposed to delay implementation
of our definition of the substantive portion as more than half of the
total time until January 1, 2024. We continued to believe it is
appropriate to define the substantive portion of a split (or shared)
service as more than half of the total time, and proposed that this
policy will be effective beginning January 1, 2024. While we continued
to believe that the definition of substantive portion we finalized in
the CY 2022 PFS final rule is appropriate, delaying implementation of
this aspect of our policy would also allow for the changes in the
coding and payment policies for Other E/M visits to take effect for CY
2023, and allow for a one-year transition for providers to get
accustomed to the new changes and adopt their workflow in practice.
Additionally, this delay would allow interested parties another
opportunity to comment on this policy, and gives us time to consider
more recent feedback and evaluate whether there is a need for
additional rulemaking on this aspect of our policy. To reflect the
proposed delay, we proposed to amend our regulation text at 42 CFR
415.140 to revise the definition of substantive portion, and noted the
current definition of substantive portion applies for visits other than
critical care visits furnished in CY 2022 and CY 2023.
We proposed to amend Sec. 415.140 by adding to paragraph (a) ``and
2023'' after the phrase ``For visits other than critical care visits
furnished in calendar year 2022''. Therefore, the proposed paragraph
would specify, for visits other than critical care visits furnished in
calendar year 2022 and 2023, substantive portion means one of the three
key components (history, exam or MDM) or more than half of the total
time spent by the physician and NPP performing the split (or shared)
visit.
We received comments related to our proposal to delay
implementation of the definition of substantive portion, as more than
half of the time spent by the physician and non-physician practitioner
(NPP), until CY 2024. Below is a summary of the comments received and
their responses.
Comment: Commenters were generally in support of the delay. We
received a number of comments consistent with the public comments that
we received and addressed in our CY 2022 final rule (86 FR 65152
through 86 FR 65156). These commenters believe that tracking the time
for purposes of determining the substantive portion for billing is too
burdensome, and they recommend that we allow MDM to serve as the
substantive portion, potentially supported by an attestation statement
from the billing practitioner in the medical record affirming that the
billing practitioner furnished the MDM. Some commenters were concerned
that defining the substantive portion of a service by time alone would
disrupt collaborative and team-based care, and interfere with the way
care is delivered in the facility setting. Some commenters also offered
that there is significant variability in how much time it takes to
perform elements of the visit, depending on the level of training and
expertise of the physician and NPP. They stated that using MDM to
direct the management of the patient's care determines the course of
treatment for the patient, but it typically does not require the most
time. Some commenters recommended that we remove our split (or shared)
visit policy.
Response: We thank the commenters for their views and suggestions,
and note that we have previously addressed these issues. These comments
were consistent with the comments we received when we finalized in the
CY 2022 PFS final rule (86 FR 65152 through 86 FR 65156). We appreciate
hearing from these interested parties and will continue to consider the
issues raised in their comments for possible future rulemaking.
Comment: The AMA indicated in its public comment letter that it
intended to refer the definition of split (or shared) services back to
CPT for potential further review.
Response: We will review any revisions made by the CPT Editorial
Board to standardized language, including any definition of
``substantive portion'' for split (or shared) services. We will take
any revised CPT definitions or guidance into consideration for possible
future rulemaking.
Comment: One commenter suggested an alternative policy that would
create a ``carve out'' for rural practitioners, whereby practitioners
furnishing split (or shared) services in rural areas or Health
Professional Shortage Areas (HPSAs) would be able to use MDM as the
substantive portion. Some commenters suggested discontinuing
differential PFS payment for physicians and NPPs, or suggested
splitting the difference to 7.5 percent.
Response: We appreciate the commenters' concerns and will continue
to consider the potential impact of our policy on rural or health
professional shortage areas for future rulemaking. The differential
payment to physicians and NPPs is a statutory requirement. Therefore,
we do not have discretion to discontinue or modify the differential PFS
payment rates for services furnished and billed by physicians and NPPs.
Comment: Several commenters were unclear how performance of the
history or exam could be considered a substantive portion under the new
CPT framework for facility E/M visits, where
[[Page 69616]]
MDM or time will be used to select the level of service.
Response: We thank the commenters for seeking clarification. Given
the proposed delayed implementation of our substantive portion policy
until CY 2024, our current policy remains in place. As such, when an E/
M visit requires a medically appropriate history and/or physical exam,
in accordance with its code descriptor, these service element(s) can
qualify as the substantive portion, when performed.
After considering the public comments we received, we are
finalizing our proposed policy to delay implementation of our
definition of the substantive portion as more than half of the total
practitioner time until January 1, 2024. We are revising our
regulations at 42 CFR 415.140 accordingly.
16. Technical Correction to the Conditions for Payment: Split (or
Shared) Visits
In the CY 2022 PFS final rule (86 FR 64996), we finalized our
definition of split (or shared) visits as proposed, and codified it in
a new section of our regulations at Sec. 415.140. We established
regulation text for this definition of split (or shared) visits. We
subsequently discovered an inadvertent typographical error in the
instructions we used to codify the new regulation at Sec. 415.140.
Specifically, we added the regulation text for Sec. 415.140 under
subpart D, Physician Services in Teaching Settings, rather than subpart
C, Part B Carrier Payments for Physician Services to Beneficiaries in
Providers. Because this regulation was inadvertently included with
policies relating to teaching physician services, and is more
appropriately placed with other policies relating to payment for
physicians' services to beneficiaries in providers, we proposed to
revise our regulation to correct this error. As such, we proposed to
amend part 415 subpart D by removing the regulation at Sec. 415.140
and relocating that section to subpart C, such that subpart D will then
begin at Sec. 415.150.
We did not receive public comments on this proposal, and therefore,
we are finalizing as proposed.
17. Technical Correction for Split (or Shared) Critical Care Services
In the CY 2022 PFS final rule, starting at 86 FR 65159, we
finalized a number of billing policies for critical care CPT codes
99291 (Critical care, evaluation and management of the critically ill
or critically injured patient; first 30-74 minutes) and 99292 (each
additional 30 minutes). At 86 FR 65162, we stated in error, ``Similar
to our proposal for split (or shared) prolonged visits, the billing
practitioner would first report CPT code 99291 and, if 75 or more
cumulative total minutes were spent providing critical care, the
billing practitioner could report one or more units of CPT code
99292.'' We intended to state that CPT code 99292 could be billed after
104, not 75, or more cumulative total minutes were spent providing
critical care. As correctly stated elsewhere in the CY 2022 PFS final
rule (regarding critical care furnished by single physicians at 86 FR
65160, and regarding concurrent care furnished by multiple
practitioners in the same group and the same specialty to the same
patient at 86 FR 65162), our policy is that CPT code 99291 is
reportable for the first 30-74 minutes of critical care services
furnished to a patient on a given date. CPT code 99292 is reportable
for additional, complete 30-minute time increments furnished to the
same patient (74 + 30 = 104 minutes). We clarify that our policy is the
same for critical care whether the patient is receiving care from one
physician, multiple practitioners in the same group and specialty who
are providing concurrent care, or physicians and NPPs who are billing
critical care as a split (or shared) visit.
Comment: Although this was a technical correction, we received many
comments on this policy. Commenters requested that we review or modify
this billing policy. Many commenters urged us to adopt CPT's policy for
reporting CPT code 99292 when 75 minutes had elapsed. Commenters also
contended that this correction reflected a change in our billing policy
for these codes. Some commenters also suggested that this policy
amounted to an undervaluation for CPT code 99291. These commenters
suggested that, while the purported time for CPT code 99291 is 30-74
minutes, our policy essentially extends the time covered by CPT code
99291 from 30-103 minutes.
Response: We agree with commenters that our policy as expressed in
the CY 2022 final rule is different from the billing guidance in the
CPT codebook. While we often align with CPT, there will be occasions
when our billing policies differ. Specific to critical care, we noted
in the CY 2022 PFS final rule at 86 FR 65159, ``We proposed to adopt
the CPT prefatory language for critical care services as currently
described in the CPT Codebook, except as otherwise specified [emphasis
added].'' We then went on to specify in the CY 2022 PFS final rule a
billing policy for reporting CPT code 99292 that is different from the
CPT guidance.
We disagree that the technical correction reflects a change in
policy as it was presented in the CY 2022 PFS final rule. At 86 FR
65160, we stated, ``Under our proposal, the physician or NPP would
report CPT code 99291 for the first 30-74 minutes of critical care
services provided to a patient on a given date . . . Thereafter, the
physician or NPP would report CPT code 99292 for additional 30-minute
time increments provided to the same patient.''
At 86 FR 65162, we specified, ``[The] total time spent by the
practitioners could be aggregated to meet the time requirement to bill
CPT code 99291. Under this proposal, once the cumulative required
critical care service time is met to report CPT code 99291, CPT code
99292 could not be reported by a practitioner in the same specialty and
group unless and until an additional 30 minutes of critical care
services are furnished to the same patient on the same day (74 minutes
+ 30 minutes = 104 total minutes).''
At this time, as we were not proposing a new policy for CY 2023, we
are retaining the CPT code 99292, as it was finalized in the CY 2022
PFS, and we again note that it can be billed after 104 cumulative total
minutes were spent providing critical care. However, we will take
commenters' concerns regarding alignment with CPT instructions and the
valuation of CPT code 99291 under consideration.
G. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, practice expense
(PE), and malpractice (MP)). We discuss the localities established
under the PFS below in this section. Although the statute requires that
the PE and MP GPCIs reflect full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
one-quarter of the relative cost differences compared to the national
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
1.5 work GPCI floor for services furnished in Alaska beginning January
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
GPCI floor for services furnished in Frontier States (as defined in
section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
Additionally, section
[[Page 69617]]
1848(e)(1)(E) of the Act provides for a 1.0 floor for the work GPCIs,
which has been extended by many successive amendments to the statute.
The 1.0 floor for the work GPCI under section 1848(e)(1)(E) of the Act
was most recently extended by section 101 of the Consolidated
Appropriations Act of 2021 (Pub. L. 116-260, enacted December 27, 2020)
through CY 2023 (that is, for services furnished no later than December
31, 2023). Therefore, as proposed, the CY 2023 work GPCIs and
summarized GAFs reflect the 1.0 work floor. Additionally, as required
by sections 1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor
for Alaska and the 1.0 PE GPCI floor for Frontier States are permanent,
and therefore, were reflected in the CY 2023 proposed GPCIs.
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed
since the date of the last previous GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be \1/2\ of
the adjustment that otherwise would be made. Therefore, since more than
1 year has passed since the previous GPCI update was implemented in CY
2020 and 2021, we proposed to phase in \1/2\ of the proposed GPCI
adjustment in CY 2023 and the remaining \1/2\ of the adjustment for CY
2024.
We have completed our review of the GPCIs and are finalizing new
GPCIs beginning for CY 2023 in this final rule. We also calculated a
geographic adjustment factor (GAF) for each PFS locality. The GAFs are
a weighted composite of each PFS locality's proposed work, PE and MP
expense GPCIs using the national GPCI cost share weights. While we do
not actually use GAFs in computing the fee schedule payment for a
specific service, they are a useful metric for purposes of comparing
overall costs and payments across fee schedule areas. The actual effect
of GPCIs on payment for any actual service would deviate from the GAF
to the extent that the proportions of work, PE and MP RVUs for the
service differ from those reflected in the GAF.
As noted above, section 101 of the Consolidated Appropriations Act
of 2021 extended the 1.0 work GPCI floor for services furnished through
December 31, 2023. Therefore, the final CY 2023 work GPCIs and
summarized GAFs reflect the 1.0 work floor. Additionally, as required
by sections 1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor
for Alaska and the 1.0 PE GPCI floor for Frontier States are permanent,
and therefore, reflected in the CY 2023 final GPCIs. See Addenda D and
E to this final rule for the CY 2023 final GPCIs and summarized GAFs.
These Addenda are available on the CMS website under the supporting
documents section of the CY 2023 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Payment Locality Background
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments under this system largely
reflected the charging patterns of physicians, which resulted in large
differences in payment for physicians' services among types of
services, physician specialties and geographic payment areas.
Local Medicare carriers initially established 210 payment
localities, to reflect local physician charging patterns and economic
conditions. These localities changed little between the inception of
Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we
undertook a study that culminated in a comprehensive locality revision
(based on locality resource cost differences as reflected by the GPCIs)
that we implemented in 1997. The development of the current locality
structure is described in detail in the CY 1997 PFS final rule (61 FR
34615) and the subsequent final rule with comment period (61 FR 59494).
The revised locality structure reduced the number of localities from
210 to 89, and increased the number of Statewide localities from 22 to
34.
Section 220(h) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, enacted April 1, 2014) required modifications to the
payment localities in California for payment purposes beginning with
2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through
80268) we established 23 additional localities, increasing the total
number of PFS localities from 89 to 112. The current 112 payment
localities include 34 Statewide areas (that is, only one locality for
the entire State) and 75 localities in the other 16 States, with 10
States having two localities, two States having three localities, one
State having four localities, and three States having five or more
localities. The remainder of the 112 PFS payment localities are
comprised as follows: the combined District of Columbia, Maryland, and
Virginia suburbs; Puerto Rico; and the Virgin Islands. We note that the
localities generally represent a grouping of one or more constituent
counties.
The current 112 fee schedule areas, also referred to as payment
localities, are defined alternatively by State boundaries (Statewide
areas for example, Wisconsin), metropolitan areas (for example,
Metropolitan St. Louis, MO), portions of a metropolitan area (for
example, Manhattan), or rest-of-State areas that exclude metropolitan
areas (for example, Rest of Missouri). This locality configuration is
used to calculate the GPCIs that are in turn used to calculate
geographically adjusted payments for physicians' services under the
PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a State. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. We refer readers to the
CY 2014 PFS final rule with comment period (78 FR 74384 through 74386)
for further discussion regarding additional information about locality
configuration considerations.
3. GPCI Update
As required by the statute, we developed GPCIs to measure relative
cost differences among payment localities compared to the national
average for each of the three fee schedule components (that is, work,
PE, and MP). The changes to the proposed CY 2023 GPCIs for each
locality reflected the updated resource cost data in each area to
better adjust PFS payments for geographic cost differences compared to
national average costs. We noted that the changes in the proposed GPCIs
reflect the statutory floors and limitations on variation discussed
above that may advantage some rural localities. We described the data
sources and methodologies we use to calculate each of the three GPCIs
below in this section. Additional information on the CY 2023 GPCI
update is available in a final report, ``Final Report for the CY 2023
Update of GPCIs and MP RVUs for the Medicare PFS,'' on our website
located under the supporting documents section for the CY 2023 PFS
final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
The work GPCIs are designed to reflect the relative cost of
physician labor by Medicare PFS locality. As required by statute, the
work GPCI reflects one quarter of the relative wage
[[Page 69618]]
differences for each locality compared to the national average.
To calculate the work GPCIs, we use wage data for seven
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to
the national average, as a proxy for physicians' wages. Physicians'
wages are not included in the occupation categories used in calculating
the work GPCI because Medicare payments are a key determinant of
physicians' earnings. Including physician wage data in calculating the
work GPCIs would potentially introduce some circularity to the
adjustment since Medicare payments typically contribute to or influence
physician wages. That is, including physicians' wages in the physician
work GPCIs would, in effect, make the indices, to some extent,
dependent upon Medicare payments.
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more recent Census
because the ``long form'' was discontinued. Therefore, we used the
median hourly earnings from the 2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational Employment and Wage Statistics (OEWS),
formerly known as Occupational Employee Statistics (OES), wage data as
a replacement for the 2000 Census data. The BLS OEWS data meet several
criteria that we consider to be important for selecting a data source
for purposes of calculating the GPCIs. For example, the BLS OEWS wage
and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OEWS is updated regularly, and includes
a comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OEWS data (2009 through 2011) as a replacement for the 2006
through 2008 data to compute the work GPCIs; for the CY 2017 GPCI
update, we used updated BLS OEWS data (2011 through 2014) as a
replacement for the 2009 through 2011 data to compute the work GPCIs;
and for the CY 2020 GPCI update, we used updated BLS data (2014 through
2017) as a replacement for the 2011 through 2014 data to compute the
work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OEWS data continue to be the
most appropriate source of wage and employment data for use in
calculating the work GPCIs (and as discussed below, the employee wage
component and purchased services component of the PE GPCI). Therefore,
for the CY 2023 GPCI update, we used updated BLS OEWS data (2017
through 2020) as a replacement for the 2014 through 2017 data to
compute the proposed work GPCIs.
b. Practice Expense (PE) GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising PEs (not including MP
expenses) among the PFS localities as compared to the national average
of these costs. Whereas the physician work GPCIs (and as discussed
later in this section, the MP GPCIs) are comprised of a single index,
the PE GPCIs are comprised of four component indices (employee wages;
purchased services; office rent; and equipment, supplies and other
miscellaneous expenses). The employee wage index component measures
geographic variation in the cost of the kinds of skilled and unskilled
labor that would be directly employed by a physician practice. Although
the employee wage index adjusts for geographic variation in the cost of
labor employed directly by physician practices, it does not account for
geographic variation in the cost of services that typically would be
purchased from other entities, such as law firms, accounting firms,
information technology consultants, building service managers, or any
other third-party vendor. The purchased services index component of the
PE GPCI (which is a separate index from employee wages) measures
geographic variation in the cost of contracted services that physician
practices would typically buy. For more information on the development
of the purchased service index, we refer readers to the CY 2012 PFS
final rule with comment period (76 FR 73084 through 73085). The office
rent index component of the PE GPCI measures relative geographic
variation in the cost of typical physician office rents. For the
medical equipment, supplies, and miscellaneous expenses component, we
believe there is a national market for these items such that there is
not significant geographic variation in costs. Therefore, the
equipment, supplies and other miscellaneous expense cost index
component of the PE GPCI is given a value of 1.000 for each PFS
locality.
For the previous update to the GPCIs (implemented in CY 2020), we
used 2014 through 2017 BLS OEWS data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed previously in
this section, because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OEWS is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the CY 2023 GPCI update, we used updated BLS
OEWS data (2017 through 2020) as a replacement for the 2014 through
2017 data for purposes of calculating the employee wage component and
purchased service index component of the PE GPCI.
In calculating the CY 2023 GPCI update for the office rent index
component of the PE GPCI, we used the 2015 through 2019 American
Community Survey (ACS) 5-year estimates as a replacement for the 2013
through 2017 ACS data. The 2016 through 2020 5-year estimates were
supposed to be released in December 2021, but the release date was
delayed to March 17, 2022. Therefore, the recent 2015 through 2019 5-
year estimates, which preceded any COVID-19 impacts, were used in the
CY 2023 GPCI update, rather than the 2016 through 2020 ACS data, which
were not publicly released in time for the development of the proposed
rule. The Census Bureau noted that COVID-19 impacted data collection
for the 2020 ACS, and the resulting challenges have the potential to
affect the quality of the data. In particular, the Census Bureau noted
that there were lower response rates, and nonresponse bias was found in
the data collected for 2020.\108\ We will analyze the ACS data
collected in 2020 and subsequent years that occurred during the COVID-
19 pandemic, and consider using those data for the next GPCI update
after we better understand their integrity and validity for our
purposes. Because the office rent index is based on 5-year estimates,
we expect minimal impact from the non-response bias in the CY 2020 data
on the next GPCI update, but we will examine the subsequent years' ACS
data that could be similarly impacted by conditions during the COVID-19
pandemic. Because the 2020 ACS data were not released in time for us to
use them in the development of the proposed rule, and the public would
not have an opportunity to comment on the use of those data if we were
to adjust the proposed GPCIs in the final rule to
[[Page 69619]]
reflect the 2020 ACS data, we noted that we would not consider using
the 2020 ACS data for the CY 2023 final GPCIs.
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\108\ https://www.census.gov/library/working-papers/2021/acs/2021_CensusBureau_01.html.
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c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
To ensure that premium data are homogenous and comparable across
geographic areas, data were collected for policies with uniform
coverage limits of $1 million per occurrence and $3 million aggregate
($1 million/$3 million). The MP GPCIs are calculated based on insurer
rate filings of premium data for $1 million/$3 million mature claims-
made policies (policies for claims made rather than losses occurring
during the policy term). For the CY 2020 GPCI update, we used premium
data presumed in effect as of December 10, 2017. The CY 2023 MP GPCI
update reflects premium data presumed in effect no later than December
31, 2020. We note that we finalized a few technical refinements to the
MP GPCI methodology in CY 2017, and refer readers to the CY 2017 PFS
final rule (81 FR 80270) for additional discussion of those.
d. GPCI Cost Share Weights
For the CY 2023 GPCIs, we proposed to continue to use the current
2006-based MEI cost share weights for determining the proposed PE GPCI
values. Specifically, we use the cost share weights to weight the four
components of the PE GPCI: employee compensation, office rent,
purchased services, and medical equipment, supplies, and other
miscellaneous expenses, as shown in Table 22. We refer readers to the
CY 2014 PFS final rule with comment period (78 FR 74382 through 74383),
for further discussion regarding the 2006-based MEI cost share weights
revised in CY 2014 that we also finalized for use in the CY 2017 and CY
2020 GPCI updates.
We noted that we proposed to rebase and revise the MEI cost share
weights for CY 2023, and we referred readers to the detailed discussion
in section II.M. of the proposed rule, but we proposed to maintain the
use of the current 2006-based MEI cost share weights for the CY 2023
GPCIs, thus delaying the implementation of the rebased and revised MEI
cost share weights for this purpose. We refer readers to our discussion
about using the proposed rebased and revised MEI cost share weights for
purposes of proportioning the work, PE, and MP RVU pools in PFS
ratesetting and for the purposes of updating the GPCIs for CY 2023 in
sections II.B. and VI. of this final rule. In those sections, we
discuss our considerations for updating the MEI cost share weights for
the RVUs and the GPCIs and the potential redistributive impact that
making such a change would have on PFS payments. We have historically
updated the GPCI cost share weights to make them consistent with the
most recent update to the MEI, which was most recently done for CY 2014
(78 FR 74382 through 74383). However, in light of the overall impacts
of making this change and in the interest of maintaining stability in
payments, we proposed to maintain the use of the current 2006-based MEI
cost share weights for the CY 2023 final PE GPCIs. We believe that
allowing interested parties the opportunity to review and comment on
the proposed rebased and revised MEI cost share weights as discussed in
section II.M. of the proposed rule and their potential impacts before
we actually use such rebased and revised MEI cost share weights for
purposes of proportioning the work, PE, and MP RVU pools in PFS
ratesetting and updating the GPCIs is important. This approach
maintains consistency in the data used to update both the GPCI and PFS
ratesetting inputs for CY 2023; the proposal to delay implementation of
the rebased and revised MEI cost share weights is consistent with our
efforts to balance payment stability and predictability with
incorporating new data through more routine updates. We refer readers
to section VI. of this final rule for additional discussion on this
issue and impacts as it relates to PFS ratesetting and the GPCI update
for CY 2023. We also refer readers to the comment solicitation in
section II.B. of this final rule, where we discuss our ongoing efforts
to update data inputs for PE to aid stability, transparency,
efficiency, and data adequacy. In addition, we direct readers to the CY
2011 PFS final rule (75 FR 73256) where we similarly delayed
implementation of updated MEI cost share weights in response to
commenters' concerns about our separate, ongoing analysis that would
inform future GPCI changes and the reallocation of labor-related costs
from the medical equipment and supplies and miscellaneous component to
the employee compensation component of the PE GPCI.
In the CY 2011 PFS final rule (75 FR 73256), we acknowledged that
we typically update the GPCI cost share weights concurrently with the
most recent MEI rebasing and revision, but in consideration of the
commenters' concerns in response to the proposed rule, we did not use
the revised cost share weights for the CY 2011 GPCIs and instead
finalized the implementation of the rebased and revised MEI cost share
weights through subsequent rulemaking. We invited comments on the delay
in implementation of the MEI cost share weights for purposes of the CY
2023 GPCIs and PFS ratesetting, given the impacts discussed in section
VI. of the proposed rule (87 FR 46419 through 46425). We also solicited
comments on how best to proceed with implementation of the rebased and
revised MEI cost share weights in the future. More specifically, we
sought comment on how best to incorporate the MEI cost share weights
into the PE GPCI if we were to implement them outside the statutorily
required triennial update in which we phase in all aspects of the GPCI
update through the previously discussed 2-year (\1/2\ in each year)
phase-in required by section 1848(e)(1)(C) of the Act. Section
1848(e)(1)(C) of the Act requires that, if more than one year has
elapsed since the date of the last GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be \1/2\ of
the adjustment that otherwise would be made. Therefore, specifically,
we sought comment on potentially incorporating the rebased and revised
MEI cost share weights into the CY 2024 GPCIs. We noted that we would
not be required by statute to phase in the adjustment over 2 years as
specified in section 1848(e)(1)(C) of the Act because, in CY 2024, no
more than one year would have elapsed since the last GPCI adjustment.
Therefore, we also sought comment on whether it would be appropriate to
use a multi-year transition to incorporate the rebased and revised MEI
cost share weights for purposes of the PE GPCI and PFS ratesetting as
we have done in the past when incorporating other new data into the PFS
payment methodology (for example, the clinical labor update), or if,
because the MEI cost share weights only impact the composition of the
PE GPCI, such a transition would not be warranted. If we were to
instead apply the rebased and revised MEI cost share weights for
purposes of the PE GPCI and PFS ratesetting for CY 2025 or later, we
would be required under section 1848(e)(1)(C) of the Act to phase in
the GPCI adjustments over 2 years. We sought comments on whether, in
that case, it would be appropriate to similarly apply a transition to
implement the MEI cost share weights for purposes of PFS ratesetting as
well, and referred readers to section II.B and VII. of the proposed
rule for more
[[Page 69620]]
discussion regarding the alternatives considered and impacts of a
phase-in of the rebased and revised MEI cost share weights in PFS
ratesetting. The final CY 2023 GPCI cost share weights are displayed in
Table 25. We note that the finalized rebased and revised cost share
weights discussed in detail in section II.M. of this final rule are
also displayed in Table 25 for awareness regarding potential future
rulemaking and GPCI updates.
[GRAPHIC] [TIFF OMITTED] TR18NO22.052
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in Frontier States
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in States determined to be Frontier
States. In general, a Frontier State is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
have a population per square mile of less than 6. For more information
on the criteria used to define a Frontier State, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the States identified
as Frontier States for the CY 2023 PFS proposed rule. The qualifying
States are: Montana; Wyoming; North Dakota; South Dakota; and Nevada.
In accordance with statute, we will apply a 1.0 PE GPCI floor for these
States in CY 2023.
f. Methodology for Calculating GPCIs in the U.S. Territories
Prior to CY 2017, for all the island territories other than Puerto
Rico, the lack of comprehensive data about unique costs for island
territories had minimal impact on GPCIs because we used either the
Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and
Northern Mariana Islands) or used the unadjusted national averages (for
the Virgin Islands). In an effort to provide greater consistency in the
calculation of GPCIs given the lack of comprehensive data regarding the
validity of applying the proxy data used in the States in accurately
accounting for variability of costs for these island territories, in
the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a
policy to treat the Caribbean Island territories (the Virgin Islands
and Puerto Rico) in a consistent manner. We do so by assigning the
national average of 1.0 to each GPCI index for both Puerto Rico and the
Virgin Islands. We refer readers to the CY 2017 PFS final rule for a
comprehensive discussion of this policy.
g. California Update to the Fee Schedule Areas Used for Payment Under
Section 220(h) of the Protecting Access to Medicare Act
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act that modified the fee schedule areas used for payment purposes in
California beginning in CY 2017. Prior to CY 2017, the fee schedule
areas used for payment in California were based on the revised locality
structure that was implemented in 1997 as previously discussed.
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that
the fee schedule areas used for payment in California must be
Metropolitan Statistical Areas (MSAs) as defined by the Office of
Management and Budget (OMB) as of December 31 of the previous year; and
section 1848(e)(6)(A)(ii) of the Act required that all areas not
located in an MSA must be treated as a single rest-of-State fee
schedule area. The resulting modifications to California's locality
structure increased its number of fee schedule areas from 9 under the
current locality structure to 27 under the MSA-based locality
structure; although for the purposes of payment, the actual number of
fee schedule areas under the MSA-based locality structure is 32. We
refer readers to the CY 2017 PFS final rule (81 FR 80267) for a
detailed discussion of this operational decision.
Section 1848(e)(6)(D) of the Act defined transition areas as the
counties in fee schedule areas for 2013 that were in the rest-of-State
locality, and locality 3, which was comprised of Marin County, Napa
County, and Solano County. Section 1848(e)(6)(B) of the Act specified
that the GPCI values used for payment in a transition area are to be
phased in over 6 years, from 2017 through 2022, using a weighted sum of
the GPCIs calculated under the new MSA-based locality structure and the
GPCIs calculated under the PFS locality structure that was in place
prior to CY 2017. That is, the GPCI values applicable for these areas
during this transition period were a blend of what the GPCI values
would have been for California under the locality structure that was in
place prior to CY 2017, and what the GPCI values would be for
California under the MSA-based locality structure. For example, in CY
2020, which represented the fourth year of the transition period, the
applicable GPCI values for counties that were previously in the rest-
of-State locality or locality 3 and are now in MSAs were a blend of \2/
3\ of the GPCI value calculated for the year under the MSA-based
locality
[[Page 69621]]
structure, and \1/3\ of the GPCI value calculated for the year under
the locality structure that was in place prior to CY 2017. The
proportions continued to shift by \1/6\ in each subsequent year so
that, by CY 2021, the applicable GPCI values for counties within
transition areas were a blend of \5/6\ of the GPCI value for the year
under the MSA-based locality structure, and \1/6\ of the GPCI value for
the year under the locality structure that was in place prior to CY
2017. Beginning in CY 2022, the applicable GPCI values for counties in
transition areas were the values calculated solely under the new MSA-
based locality structure; therefore, the phase-in for transition areas
is complete. Additionally, section 1848(e)(6)(C) of the Act establishes
a hold harmless requirement for transition areas beginning with CY
2017; whereby, the applicable GPCI values for a year under the new MSA-
based locality structure may not be less than what they would have been
for the year under the locality structure that was in place prior to CY
2017. There are 58 counties in California, 50 of which were in
transition areas as defined in section 1848(e)(6)(D) of the Act. The
eight counties that were not within transition areas are: Orange; Los
Angeles; Alameda; Contra Costa; San Francisco; San Mateo; Santa Clara;
and Ventura counties. We note that while the phase-in for transition
areas is no longer applicable, the hold harmless requirement is not
time-limited, and therefore, is still in effect.
For the purposes of calculating budget neutrality and consistent
with the PFS budget neutrality requirements as specified under section
1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by
calculating the national GPCIs as if the fee schedule areas that were
in place prior to CY 2017 are still applicable nationwide; then, for
the purposes of payment in California, we override the GPCI values with
the values that are applicable for California consistent with the
requirements of section 1848(e)(6) of the Act. This approach to
applying the hold harmless requirement is consistent with the
implementation of the GPCI floor provisions that have previously been
implemented--that is, as an after-the-fact adjustment that is made for
purposes of payment after both the GPCIs and PFS budget neutrality have
already been calculated.
Additionally, section 1848(e)(1)(C) of the Act requires that, if
more than 1 year has elapsed since the date of the last GPCI
adjustment, the adjustment to be applied in the first year of the next
adjustment shall be \1/2\ of the adjustment that otherwise would be
made. For a comprehensive discussion of this provision, transition
areas, and operational considerations, we refer readers to the CY 2017
PFS final rule (81 FR 80265 through 80268).
(1) Proposed Refinement to Number of Unique Fee Schedule Areas in
California
In the CY 2020 final rule (84 FR 62622), a commenter indicated that
some of the distinct fee schedule areas that were used during the
period between CY 2017 and CY 2018 are no longer necessary.
Specifically, with regard to the Los Angeles-Long Beach-Anaheim MSA,
which contains 2 counties (across two unique locality numbers, 18 and
26) that are not transition areas, we acknowledge that we only needed
more than one unique locality number for that MSA for payment purposes
in CY 2017, which was the first year of the implementation of the MSA-
based payment locality structure. Neither of the counties in the Los
Angeles-Long Beach-Anaheim MSA (Orange County and Los Angeles County)
are transition areas under section 1848(e)(6)(D) of the Act. Therefore,
the counties were not subject to the aforementioned GPCI value
incremental phase-in (which is no longer applicable) or the hold-
harmless provision at section 1848(e)(6)(C) of the Act. Similarly, the
San Francisco-Oakland-Berkeley MSA contains four counties--San
Francisco, San Mateo, Alameda, and Contra Costa counties--across three
unique locality numbers, 05, 06, and 07. These counties are not
transition areas and will receive the same GPCI values, for payment
purposes, going forward. In response to the comment, we acknowledged
that we did not propose any changes to the number of fee schedule areas
in California, but would consider the feasibility of a technical
refinement to consolidate into fewer unique locality numbers; and if we
determined that consolidation was operationally feasible, we would
propose the technical refinement in future rulemaking. This refinement
would ultimately change the number of distinct fee schedule areas for
payment purposes in California from 32 to 29. In light of the
foregoing, for CY 2023, we proposed to identify the Los Angeles-Long
Beach-Anaheim MSA, containing Orange County and Los Angeles County, by
one unique locality number, 18, as opposed to two, thus retiring
locality number 26, as it is no longer needed. Similarly, we proposed
to identify the San Francisco-Oakland-Berkeley MSA containing San
Francisco, San Mateo, Alameda, and Contra Costa counties by one unique
locality number, 05, as opposed to four, thus retiring locality numbers
06 and 07, as they are no longer needed. Additionally, we noted that we
would modify the MSA names as follows: the San Francisco-Oakland-
Berkeley (San Francisco Cnty) locality (locality 05) would become San
Francisco-Oakland-Berkeley (San Francisco/San Mateo/Alameda/Contra
Costa Cnty), and Los Angeles-Long Beach-Anaheim (Los Angeles Cnty)
locality (locality 18) would become Los Angeles-Long Beach-Anaheim (Los
Angeles/Orange Cnty). We noted that because Marin County is in a
transition area and subject to the hold harmless provision at section
1848(e)(6)(C) of the Act, we needed to retain a unique locality number
for San Francisco-Oakland-Berkeley (Marin Cnty), locality 52. We sought
comment on the proposed technical refinements to consolidate unique fee
schedule areas and their locality numbers in California, where the
unique localities are not operationally necessary. Based on support
from commenters, we are finalizing to identify the Los Angeles-Long
Beach-Anaheim MSA, containing Orange County and Los Angeles County, by
one unique locality number, 18, and the San Francisco-Oakland-Berkeley
MSA containing San Francisco, San Mateo, Alameda, and Contra Costa
counties by one unique locality number, 05, as proposed. While we
believe these changes are appropriate to consolidate fee schedules
areas that are no longer operationally necessary, we are unable to
operationalize these changes for CY 2023 due to timing constraints
relating to the actions and coordination with the various systems
maintainers required to effectuate changes to claims processing.
Therefore, for CY 2023, there will be no changes to the existing
locality numbers 05, 06, 08, 18, or 26. We intend to operationalize
these finalized changes for CY 2024. We note that these changes, when
operationalized, do not have any payment implications under the PFS.
h. Refinements to the GPCI Methodology
In the process of calculating GPCIs for the purposes of the
proposed rule, we identified four technical refinements to the
methodology that yielded improvements over the current method; these
refinements are applicable to the work and MP GPCIs, the employee wage
index component of the PE GPCI, and the GAFs. For purposes of the final
rule, we are finalizing these changes as proposed.
[[Page 69622]]
We conducted a thorough review of the BLS OEWS occupation codes
within each of the seven occupation groups used in past updates to
track and document the changes over time. As new BLS OEWS data are
released, the availability of specific occupation codes is subject to
change, and it is possible that new codes can be added, changed, or
removed over time; therefore, we believe it is important to
periodically review and update the occupation groups and codes based on
our review during the GPCI updates. We reviewed the occupation codes
and groups used to capture geographic variation in professional wages
to assess other potential codes and groups that could be used in
addition to the current selections to calculate the work GPCI, with
significant consideration given to the extent to which the data exist
in the file (data existence) and how well the occupation codes are
represented in the data (data sufficiency). Based on our review, we
proposed the addition of two new occupation groups (and their
corresponding occupation codes), Management Occupations and Business
and Financial Operation Occupations, to the preexisting seven
occupation groups for CY 2023, as described in Table 20 in the proposed
rule (87 FR 46009) and Table 26 of this final rule.
[[Page 69623]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.053
We also proposed to add four occupation codes to the Computer,
Mathematical, Life, and Physical Science group, and three occupation
codes to the Social Science, Community and Social Service, and Legal
group, for
[[Page 69624]]
CY 2023, as shown in Table 21 in the proposed rule (87 FR 46010) and
Table 27 in this final rule. The practical effect of the inclusion of
these occupation groups and codes on the work GPCI is minimal because
the statute at section 1848(e)(1)(A)(iii) of the Act requires that the
work GPCI reflect only one quarter of cost differences, but their
inclusion adds meaningful data regarding the geographic variation in
professional wages for CY 2023.
[GRAPHIC] [TIFF OMITTED] TR18NO22.054
We proposed to modify the list of occupation codes used within the
first PE GPCI component, Employee Wages, to conform more closely to the
clinical labor categories used in PFS ratesetting. Specifically, six
occupation codes listed as sources for clinical labor rates used to
establish PE RVUs in PFS ratesetting that were previously inadvertently
excluded in the Employee Wage Index calculation are now included in the
final CY 2023 Employee Wage Index (29-1126, 29-1124, 19-3031, 29-1031,
29-1181, 29-1127). Lastly, we proposed a technical refinement to the
method used to calculate each locality's GAF. The GAFs are calculated
as the weighted composite of the three GPCIs (work, PE, and MP),
essentially representing the net geographic adjustment that would be
made to a theoretical standard service. Instead of the 2006-based MEI
cost share weights, which were used to calculate GAFs in previous
updates to the GPCIs, we calculated the CY 2023 GAFs using weights that
reflect the share of total RVUs that each component (work, PE, and MP)
accounts for, based on Medicare utilization data from CY 2020. The GAFs
are not used for payment under the PFS but are a useful measure to
illustrate the overall effect of geographic adjustments under the PFS
across Medicare fee schedule areas. We believe that using the share of
RVUs reflected in recent Medicare utilization data as weights when
calculating the CY 2023 GAFs results in GAFs that more accurately
reflect the composite effect of geographic adjustment on payment, year
over year, as compared to the GAFs calculated using the 2006-based MEI
cost share weights. This change also allows the use of current Medicare
utilization data that are available each year as opposed to the MEI
cost share weights that are not updated as frequently. The final
weights used to calculate the CY 2023 GAFs are displayed in Table 28.
[GRAPHIC] [TIFF OMITTED] TR18NO22.055
These four methodological refinements, including changes to: (1)
the occupation group; (2) occupation codes; (3) occupation codes used
for the Employee Wage Index; and (4) the GAF weighting adjustment,
yield improved mathematical precision in the final CY 2023 GPCIs and
GAFs by providing for a more accurate, full landscape of occupations
that should be accounted for in the work and PE GPCIs, and by aligning
the GAF equation weights to
[[Page 69625]]
use routinely available data. We are finalizing all four refinements as
proposed. Additional information on the GPCI methodology and the
refinements are available in the final report, ``Final Report for the
CY 2023 Update of GPCIs and MP RVUs for the Medicare PFS'' on our
website located under the supporting documents section of the CY 2023
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
i. Alternatives Considered Related to the Use of the American Community
Survey (ACS) Data for Office Rent Index
Commenters often express concern about the use of residential rents
as a proxy for physician office space costs for purposes of updating
the PE GPCIs, and state that CMS should collect commercial rent data
and use it either as the basis for measuring geographic differences in
physician office rents, or if this is not feasible, use it to validate
the residential rents as a proxy for physician office rents. In the
past, commenters have requested that CMS provide a specific explanation
of the barriers to obtaining better commercial rent data and that we
reevaluate existing databases to find or develop a nationwide measure
of commercial office rents for use in calculating PE GPCIs. For each
GPCI update, we have noted that our efforts are ongoing to identify a
publicly-available, robust, nationally representative commercial rent
data source that could be made available to CMS for this purpose. We
have welcomed opportunities to discuss such data sources with
interested parties and to incorporate such data, as appropriate in the
GPCI calculation process, through our annual rulemaking process.
Because Medicare is a national program, and section 1848(e)(1)(A)
of the Act requires us to establish GPCIs to measure relative cost
differences among localities compared to the national average, we
believe it is important to use the best data source that is available
on a nationwide basis, that is regularly updated, and retains
consistency area-to-area, year-to-year. The ACS is administered by the
United States Census Bureau, which is a leading source of national,
robust, high quality, publicly available data. We agree that a data
source for commercial office rents that provided for adequate
representation of urban and rural areas nationally would be preferable
to a residential rent data source as a proxy for commercial rents. We
have previously discussed in the CY 2005, CY 2008, CY 2011, and CY 2017
(69 FR 66262, 72 FR 66376, 75 FR 73257, and 81 FR 80265, respectively)
final rules that we recognize that apartment rents may not be a perfect
proxy for physician office rent.
We have conducted searches for commercial rent data sources for
consideration as an alternative to the ACS data in the past and have
not found or received public comments with suggestions of reliable data
sources that meet our needs. As discussed in the proposed rule, for CY
2023, we conducted another search for reliable commercial rent data
sources that are publicly available for the CY 2023 update and did not
find any reliable data sources that would meet our needs. The principal
characteristic of any substitute data source for the ACS data would be
that it captures geographic variation in the office space cost for
physician practices. We primarily investigated sources that report data
on commercial real estate, but we also considered a few residential
rent data sources and one data source that reports on a type of
property that would be unable to house a physician practice--U.S. Post
Office (P.O.) box rentals. Because the underlying property in which the
P.O. boxes are located is commercial in nature, the rental rates may
reflect the underlying geographic variation in facility cost. Because
this source has other features that are important for creating a
geographic index, we have included it for consideration. Although
interested parties may prefer a database focused on the types of
properties that physicians would use for offices (that is, a commercial
rent database), the identified potential data alternatives discussed
below failed to meet one or more of five criteria that we believe are
critical to the creation of an appropriate geographic index.
We used the following five criteria to analyze the potential data
sources for this search: (1) applicability to planned use; (2)
standardization of the measure; (3) potential bias; (4) geographic
scope, distribution, and granularity of the data; and (5) availability,
continuity, and price of the data. Our review revealed challenges with
the commercial real estate market data in several of these criteria.
Under the first criterion, there are two sub-criteria that present
problems with the type of real estate data reported when we considered
their use for creating a geographic index: (1A) leases versus sales of
commercial real estate, and (1B) comparables versus listings versus
assessments of commercial real estate. For the first sub-criterion, the
commercial and residential real estate markets can be subdivided into
markets for leases and sales. Terms for commercial leased properties
are often varied and not readily available. Commercial sales,
especially of office condominiums, may be more readily available and
require less adjustment for use in a geographic index. The availability
of different arrangements--leasing versus owning--may vary
geographically, affecting the underlying stability and
representativeness of an index based on either. Under the second sub-
criterion, an important distinction is whether the data in the
alternative data source represents closed transactions (known as
``comparables'' or ``comps'') or asking prices (known as ``listings''),
regardless of whether the source is reporting data for leased or sales
of commercial property. Because asking prices are often aspirational,
professional real estate appraisers rely on comparable transactions in
order to estimate a price for sale or lease. Therefore, comparables
provide the most reliable substitute dataset for consideration for use
in creating a geographic index. Assessments are the estimated values of
real property set by the tax assessors in each State, which are
generally intended to reflect full cash value of the property, though
there may be State-specific laws and regulations that interfere (that
is, by limiting the percentage increase in a property from year to year
if it has not been transferred). Assessments for commercial properties
often rely heavily on the ``income method'' of valuation, which
capitalizes the net income the property does or could receive if
rented. The advantage of assessments for use in creation of a
geographic index is their existence for every property in the United
States.
The second criterion is that appropriate adjustments need to be
made to reduce variation for other factors, or the standardization of
the data reported by a considered alternative data source. The primary
data adjustment is to standardize the size of the property. For
commercial space, conversion to a price per square foot (price/SF)
value allows for direct comparison between properties. There are other
factors involved in standardizing commercial rents and sale prices. The
Building Owners and Managers Association (BOMA) groups buildings into
three property classes:
Class A: Most prestigious buildings competing for premiere
office users with rents above market average for the area. These
buildings have high quality standard finishes, state of the art
building systems and amenities, exceptional accessibility, and a
definite market presence.
[[Page 69626]]
Class B: Buildings competing for a wide range of users
with rents in the average range for the market. Buildings finishes are
good to fair for the area, and systems are adequate but the building
does not compete with Class A at the same price.
Class C: Buildings competing for tenants requiring
functional space at rents below average for the market.\109\
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\109\ https://www.boma.org/BOMA/Research-Resources/Industry_Resources/BuildingClassDefinitions.aspx.
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A dataset of commercial rentals or sales must include the building
class information so properties can be appropriately compared to each
other, similar to the way that CMS currently only compares ACS rent
data for two-bedroom apartments. For leases, the dataset would also
need to specify lease type (Single Net, Double Net, Triple Net,
Bondable Net, Full Service Gross, Modified Gross, and or
Percentage).\110\ The same property rented under a type of Net lease
would be expected to have a lower rent than if it were rented under a
Full-Service lease because the lessee would pay some amount towards
operating expenses. Although a dataset may contain an indication of the
type of lease, it may not include the amount of operating expenses paid
by the lessee that would be necessary to standardize the rent or other
terms that affected the final transaction price. There are often
considerable privacy considerations with respect to commercial
transactions in order to maintain competitive advantage, so accurate
information is often difficult to obtain. Typically, the sale price for
a leased property, assuming an arms-length transaction, accounts for
the detailed lease terms applicable to the property and likely would
not require adjustment for this factor. Another consideration is the
effective date of the transaction. Market prices for leases and sales
can change rapidly or slowly, and even transactions occurring within
the same calendar year may or may not require adjustment in order to be
reflective of the market at the intended point in time, and therefore,
the transaction date is critical for professional appraisals. Markets
are also localized, so even data reported for areas in relatively close
proximity may not experience the same price fluctuations.
---------------------------------------------------------------------------
\110\ https://www.reonomy.com/blog/post/commercial-lease-types.
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The third criterion is that potential bias is limited in a
considered alternative data source. Our search to date was unable to
locate any scientifically designed national survey of commercial
property costs. Many of the data sources are intended to facilitate the
sale of commercial property and provide listings, rather than
comparables. They also may only contain a fraction of the listings on
the market and have been selected by brokers to advertise for sale,
rather than to represent the entire market, resulting in substantial
bias. Even the most comprehensive and detailed data sources for
verified transactions are designed to support valuation of individual
properties. These databases reflect the mix of properties that are
either currently available or have been sold or leased during a defined
period. The aggregate data are not intended to produce an unbiased
estimate of the average cost per square foot in a particular geographic
area, whereas, the ACS is a scientifically designed and implemented
national housing survey created by the U.S. Census Bureau that has been
designed to reduce bias in the statistics it creates.
The fourth criterion is that the alternate data source would need
to be national in scope and sufficiently granular to capture the
characteristics of highly localized real estate markets. The ACS data
have been consistently available in each year for the majority of
counties in the nation. Although some of the commercial data sources
may range nationwide and provide property-level data, there may be a
much higher proportion of areas with missing data. An important
consideration for the office rent index is that it sufficiently
captures data in both urban and rural areas. Rural areas may have a
less active commercial real estate market than urban areas, in which
case there may be few transactions to use in a geographic index.
Lastly, the fifth criterion is that the data source be publicly
available, consistently available for CMS' GPCI update years, and/or
reasonably priced in order to facilitate transparency and
administrative efficiency. Proprietary databases can only be accessed
by those who sign up for the service, and use of the data is governed
by Terms of Service (TOS) that may preclude its use in derivative
works, such as the creation of a geographic index, or dissemination of
the data. Public databases are more likely to be accessible and able to
be used for derivative work, such as the creation of the GPCIs. Any
change in the data source we use in the creation of the index is likely
to cause changes in index values, and possibly invoke critique if the
resulting changes are significant. If CMS were to consider a change in
data source, the change would need to be sustainable over time, and
therefore, the data must be consistently accessible for subsequent GPCI
updates, and data sources must maintain consistency over time in order
to avoid any potential dramatic changes and/or the need to refine the
adjustments to a dataset each update year, which would introduce
unnecessary variation in the index. If the data source changes or
discontinues the dataset, CMS would need to find a replacement data
source, possibly within a short time period. This would likely
introduce the possibility of dramatic changes and variation in the
index that does not reflect the real geographic changes between update
years--stemming from the use of different data sources. Additionally,
the price to obtain and make necessary adjustments to the data
discussed above may be prohibitive for use in the GPCIs.
The Federal Government already paid for the construction of the
ACS, the ACS provides the data in a very usable form, CMS can
consistently and freely access the data, and relatively minor
processing is required to turn it into an index. Every proprietary
database is likely to charge substantial amounts to access the data as
it is currently provided, which will be geared to uses very different
from the creation of an office rent index. There may be substantial
work required to gather and process the data and TOS conditions imposed
by the database owners may not allow even free data to be used for the
intended purpose. In all cases, it is likely that CMS would need to
negotiate the terms for utilizing any proprietary sources.
We identified eight data sources for analysis as potential
alternatives to the ACS, but all failed to meet one or more of the five
key criteria discussed above that would allow us to better reflect
geographic cost variation for the office rent component of the PE GPCI
that is currently measured using the ACS. We specifically identified
the following potential data sources: (1) REIS[supreg] Real Estate
Solutions by Moody's Analytics[supreg]; (2) CompStak; (3)
CoStarTM; (4) Zillow[supreg] Assessor and Real Estate
Database (ZTRAX); (5) U.S. Postal Service (USPS[supreg]) P.O. Box
Rental; (6) GSA[supreg] Lease Inventory; (7) Reonomy[supreg]; and (8)
SMR Research. Three of the eight data sources had substantial costs
associated with obtaining the data, and we were unable to obtain
pricing information for an additional two of the eight without
extensive discussions with a sales representative. Two of the eight
sources lacked necessary building class information, and many of the
eight sources presented challenges with TOS restrictions,
representativeness of rural areas, small or undisclosed sample sizes,
sample sizes that differed from
[[Page 69627]]
year to year, and/or a large number of geographic areas with missing
data.
While we determined that none of these data sources are appropriate
substitutes for the ACS data we currently use, based on their failure
to meet one or more of the five key criteria discussed above, some of
the sources possess useful qualities that allowed for further
preliminary research into the correlation between commercial and
residential rent that fell within the confines of our contractual
restrictions. To investigate whether the use of ACS residential rents
captures geographic variation in office rents, as discussed above, we
identified a few data alternatives above for further research and
examined their correlation with the ACS residential rent data in effort
to evaluate the validity of the ACS data as a proxy for determining
geographic variation in office rents. Overall, our ongoing analysis
shows that the ACS residential rent data are highly correlated with
commercial rents across areas. Therefore, we have concluded that the
continued use of the ACS data for the office rent component of the PE
GPCI is appropriate. We considered the use of USPS P.O. Box Rental data
for preliminary analysis, as it is free, publicly available, and
national in scope (in all zip codes where P.O. Boxes are available),
but resource and time constraints limited us from considering this for
the CY 2023 update. P.O. Box rent data is available online, but it is
not formatted in an easy-to-use dataset that we could readily analyze
without conducting resource-intensive data extraction and preparation.
Considering that the P.O. Box rent data would have required significant
resources, and that expending such resources was not feasible for the
CY 2023 proposed rule, we identified the GSA Lease Inventory data
source as the next best alternative data source to use to evaluate the
correlation between residential and commercial rents because it is
publicly available, free, and accessible in an easy-to-use format that
required limited adjustments to allow analysis. To get a comparative
sense of the rents per square foot that would be suggested for a
specific geographic area, we chose to compare the GSA Lease Inventory
data and the ACS data for available counties in the State of Maryland.
As shown in Table 29, the GSA Lease Inventory data are missing for
approximately half of the counties in Maryland. For those counties with
available GSA data, the rent per square foot of the GSA leased
facilities is shown in Table 29 and can be compared to the
corresponding ACS residential rent data for that county.
[GRAPHIC] [TIFF OMITTED] TR18NO22.056
[[Page 69628]]
Figure 1 shows a rank order test for the counties in Maryland where
both GSA Lease Inventory data and ACS data are available. Allegany
County has the lowest rent per square foot in the GSA Lease Inventory
data and the lowest residential rent in the ACS data. Anne Arundel
County has the highest residential rent data and the second highest GSA
Lease Inventory data. Analysis shows that the rank order of the
available counties in the GSA Lease Inventory data follow a relatively
similar pattern (positive, linear relationship) to the same counties in
the ACS data.
[GRAPHIC] [TIFF OMITTED] TR18NO22.057
We expanded the comparison of the GSA Lease Inventory data with the
ACS residential rent data from available counties in Maryland to all
available counties nationwide by creating a rent per square foot
measure for all GSA Lease Inventory records using the January 2017 GSA
Leased Inventory data. The comparison was done by condensing the GSA
Lease data to the county level, merging it with the ACS data (for
counties where GSA data were available), and aggregating it to the
Medicare locality level, weighting by county population. We performed
two rank order tests for both ACS (median two-bedroom rent) and GSA
(rent per SF) measures in all available localities where at least 50
percent, and 75 percent, subsequently, of the locality population was
represented in the county-level GSA data file. Similar to our findings
from the initial analysis of Maryland counties, the expanded
comparisons generally show a positive, linear relationship between rank
of ACS (median two-bedroom rent) and rank of GSA (rent per SF)
measures. Because the GSA Lease Inventory data are not geographically
complete, our analyses were limited. GSA Lease Inventory data are
sparse or nonexistent in some counties, therefore, we calculated the
percent of the locality population and only included localities in our
analysis with county-level data where at least 50 percent (and 75
percent for the second analysis) of the locality population was
represented in the county-level GSA data file. For example, Locality A
includes county 1 and county 2. If the GSA data includes county 1 (with
a population of 1,000), but not county 2 (population of 50), we
included Locality A in the analysis, as it met the 50 percent and 75
percent thresholds. In contrast, if the GSA data includes county 2
(population of 50), but not county 1 (population of 1,000), we did not
perform analysis on Locality A. The January 2017 GSA data file includes
information on approximately 8,200 GSA leases across the country, which
were then aggregated to the county level, and then to the Medicare
locality level for our analysis. After these two aggregations, we had
enough GSA Lease Inventory data to perform two rank order tests on 52
Medicare localities, one rank order test for counties where at least 50
percent of the locality population was represented and a second rank
order test for counties where 75 percent of the locality population was
represented. We further analyzed the outlier localities (where the ACS
rank differs from the GSA rank by 30 ranks) and found that
when the population threshold increased from 50 percent to 75 percent,
we see a reduction in outliers from 13 to only two localities,
indicating that more
[[Page 69629]]
complete data (that is, 75 percent of the locality population
represented in GSA lease data) yields higher correlation between the
median two-bedroom rent in the ACS data and the rent per square foot in
the GSA data. This correlative effect supports the continued use of ACS
data in the GPCI update for CY 2023, as it indicates that GSA lease
data (a commercial rent data source) and ACS residential rents varied
similarly across geographic areas.
It is important to note that we use the ACS data to create an index
to measure cost differences, and not as a direct proxy for commercial
office rents. Rather, the ACS data are used to measure geographic
variation in residential rents, which is used as a proxy for the
geographic variation in commercial office rent. Based on our limited
analyses comparing the GSA and ACS data, which showed that commercial
and residential rents varied similarly across geographic areas, and the
lack of any identified alternative data source that meets all five of
the criteria discussed above, we believe that it is appropriate to
continue use of the ACS data.
With regard to the suggestion that CMS should collect commercial
rent data, we note that we discussed this issue in the CY 2012 PFS
final rule with comment period (76 FR 73088) and stated that the
development and implementation of a survey could take several years if
CMS were to survey physicians directly to gather data to compute the
office rent index. Additionally, we have historically not sought direct
survey data from physicians related to the GPCI to avoid issues of
circularity and self-reporting bias. In the CY 2011 PFS final rule with
comment period (75 FR 73259), we solicited public comments regarding
the benefits of utilizing physician cost reports to potentially achieve
greater precision in measuring the relative cost difference among
Medicare localities. We also asked for comments regarding the
administrative burden of requiring physicians to routinely complete
these cost reports and whether this should be mandatory for physicians'
practices. We did not receive any feedback related to that comment
solicitation during the open public comment period for the CY 2011 PFS
final rule with comment period.
We reiterate that the GPCIs are not an absolute measure of practice
costs. Rather they are a measure of the relative cost differences for
each of the three GPCI components. The U.S. Census Bureau is a Federal
agency that specializes in data collection, accuracy, and reliability,
and we continue to believe that where such a publicly available
resource exists that can provide useful data to assess geographic cost
differences in office rent, even though it is a proxy for the exact
data we seek, that we should utilize that available resource. In
addition to reviewing alternative data sources, we also explored
whether there are alternative ways of using the ACS data that could
improve geographic representation or improve interested parties'
confidence in it as a reasonable way to capture geographic variation in
office rent, including consideration of alternative ways to handle
counties where we are missing ACS data, as well as using alternative
variables within the ACS data to assess whether there are other similar
variables that have more complete data than median gross rent for two-
bedroom residences. Our research indicates that using alternatives
within the ACS would likely result in minimal changes to the resulting
index and would likely not address commenters' concerns regarding use
of residential rent data as a proxy for office rent. Our research also
suggests that the variation captured by the two-bedroom measure is
highly correlated with the geographic variation in one-bedroom and
three-bedroom units. The high correlation coefficient strengthens the
support for using the ACS two-bedroom measure to capture office rent
variation across areas. We explored the continued use of the ACS data
to see if there are other available variables that have a lower count
of missing observations. The data includes variables on the median
gross rent for no bedrooms, one bedroom, two bedrooms, three bedrooms,
four bedrooms, five or more bedrooms, and the total median gross rent.
Table 30 shows the number of observations that are missing for each of
the median gross rent variables in the 2017 5-year ACS data.
[GRAPHIC] [TIFF OMITTED] TR18NO22.058
Based on the 2017 5-year ACS data, total median gross rent and
median gross rent for three bedrooms are two available alternative
variables that have fewer missing county-level ACS data than the
currently used median gross rent for two bedrooms. However, it is
important to note that the number of missing observations for each
variable could change over time. While the median gross rent for two
bedrooms has a relatively low count for missing observations, it could
be substituted with the total median gross rent, which has the smallest
count of missing observations. In future years of ACS data, there could
be more or fewer missing observations for this list of variables.
Moving to use of the median gross rent for three bedrooms would result
in slightly fewer missing observations in the 2017 ACS 5-Year
Estimates, but this may not be the case for all update years.
There are also alternative ways of handling counties that are
missing data. In the CY 2020 update, we imputed county-level rent
estimates using the average value for a given county's MSA. Other
options include using the average value for contiguous counties, using
an average value for the county's State or removing the missing
observation from
[[Page 69630]]
the calculation. However, we note that the current method of handling
counties that are missing data is a reasonable approach and any
alternative would not likely affect the calculation materially.
Additionally, since there are so few counties that are missing data
(less than one percent), these alternatives (even if we had reason to
prefer one of them) would likely have no impact on the resulting index.
Table 31 shows the correlation coefficients between the available
residential rent variables in the ACS. The variation captured by the
two-bedroom measure is highly correlated with the geographic variation
in one-bedroom and three-bedroom units (approximately 0.9). This
relationship is similar, but not quite as prominent for the other
residential measures. The correlation coefficient between three-bedroom
and four-bedroom rent measures is also approximately 0.9. Based on our
research, the geographic variation in residential rents is consistent
regardless of specific measure used, and therefore, a change in the ACS
variable used or a change in the way of handling counties that are
missing data would likely result in minimal changes to the resulting
index.
[GRAPHIC] [TIFF OMITTED] TR18NO22.059
Given its national representation, reliability, high response rate
and frequent updates, and based on the rank order comparison of GSA and
ACS data and high correlation coefficients for the ACS residential rent
variables discussed above, we continue to believe the ACS residential
rent data is the most appropriate data source available at this time
for the purposes of calculating the rent index of the PE GPCI. We
undertook a comprehensive analysis of alternatives to the ACS data and
concluded that there is still no acceptable national data source
available for physician office or other comparable commercial rents,
and therefore, we proposed to continue to use county-level residential
rent data from the ACS as a proxy for the relative cost differences in
commercial office rents for the proposed CY 2023 update, and have done
so in calculating the CY 2023 final GPCIs.
j. GPCI Update Summary
As explained in the Background section above, section 1848(e)(1)(C)
of the Act mandates the periodic review and adjustment of GPCIs. For
each periodic review and adjustment, we publish the proposed GPCIs in
the PFS proposed rule to provide an opportunity for public notice and
comment, and allow us to consider whether any revisions in response to
comments are warranted prior to implementation. The CY 2023 updated
GPCIs for the first and second year of the 2-year phase-in, along with
the GAFs, are displayed in Addenda D and E to this final rule available
on our website under the supporting documents section of the CY 2023
PFS final rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
The following is a summary of the public comments received on the
proposed revisions to the CY 2023 GPCIs and our responses:
Comment: Some commenters expressed support for the proposed
methodological refinements to the GAF calculation and the refinement to
the number of unique fee schedule areas in California.
Response: We thank the commenters for the support of our proposed
methodological refinements to both the GAF calculation and the number
of unique fee schedule areas in California. As noted above, we are
finalizing to identify the Los Angeles-Long Beach-Anaheim MSA,
containing Orange County and Los Angeles County, by one unique locality
number, 18, and the San Francisco-Oakland-Berkeley MSA containing San
Francisco, San Mateo, Alameda, and Contra Costa counties by one unique
locality number, 05, as proposed. As noted above, there will be no
changes to the existing locality numbers 05, 06, 08, 18, or 26 for CY
2023 due to timing constraints relating to the operationalization of
these changes. As noted above, we intend to operationalize these
finalized changes for CY 2024. We note that these changes, when
operationalized, do not have any payment implications under the PFS.
Comment: Some commenters urged CMS to apply the locality RVUs
rather than the national RVUs when calculating the GAFs. One commenter
stated that this adjustment to the proposed GAF calculation methodology
would provide the most precise information at the locality level. In
doing so, the commenter stated that calculating a locality's GAF *
Total RVUs * Conversion Factor would more accurately reflect locality
payments.
Response: We remind commenters that the GAFs are a weighted
composite of each PFS locality's work, PE and MP expense GPCIs, which
were previously calculated using the national GPCI cost share weights.
For CY 2023, we proposed to update the GAF calculation to weight each
component by total RVUs that each component accounts for, based on
Medicare utilization data from CY 2020. We reiterate that we believe
using the share of RVUs reflected in recent Medicare utilization data
as weights when calculating the CY 2023 GAFs results in GAFs that more
accurately reflect the composite effect of geographic adjustment on
payment, year over year, as compared to the GAFs calculated using the
2006-based MEI cost share weights. In the proposed rule, we noted that
this change, if finalized, would allow the use of current Medicare
utilization data that are available each year as opposed to the MEI
cost share weights that are not updated as frequently. We note that the
difference between the GAFs, when calculated using the current
calculation methodology and the proposed calculation methodology is
very minimal, differing only by a maximum of 0.717 percent. We also
remind
[[Page 69631]]
commenters that we do not actually use GAFs in computing the fee
schedule payment for a specific service; rather, the GAFs are useful in
comparing overall costs and payments among fee schedule areas.
Therefore, we disagree with the commenter that utilizing the locality
RVUs when calculating the GAFs would more accurately reflect locality
payments, as we do not utilize the GAFs to calculate payment under the
PFS. We also note that because the GAFs were previously calculated
using the national GPCI cost share weights, we believe that it would be
more appropriate to use the national RVUs, rather than locality RVUs as
suggested by commenters, to aid transparency between update years. We
are finalizing the adjustment to the proposed GAF calculation
methodology as proposed.
Comment: Some commenters stated that our proposed methodologic
changes to the work GPCI occupation groups and codes create unnecessary
complexity and limited transparency. The commenters stated that CMS did
not provide an impact analysis or criteria for inclusion (that is, how
well it correlated as a proxy) other than significant consideration to
the extent to which the data exist in the file (data existence) and how
well the occupation codes are represented in the data (data
sufficiency). The commenters stated that, without further explanation,
two additional occupation groups were added to the previous seven
occupation groups, which increased the greater than 100 current
occupation codes by 60. One commenter believes that it is unlikely that
the cumulation of so many professions will accurately reflect the
relative difference in work of a single profession such as a physician;
the commenter stated that, if one were to compare the BLS OEWS data
file used for the work GPCI with that of the healthcare provider
dataset, there is a discordance. The commenters agreed that the
healthcare provider dataset should not be used for developing the work
GPCI due to circularity, but believe it can be used to validate the
proposed work GPCIs and to identify a much smaller subset of
professions that would act as more reliable proxies than what was
proposed. The commenters urged CMS to apply a smaller number of
professions to the work GPCI, as they thought that doing so would
result in a more reliable and accurate proxy for physician work, and
provide more information about the correlation between physician work
and the proxy professions to allow the public to verify its accuracy.
Response: As noted in the final report, ``Final Report for the CY
2023 Update of GPCIs and MP RVUs for the Medicare PFS,'' on our website
located under the supporting documents section for the CY 2023 PFS
final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html, we conducted a thorough review of
the BLS OEWS occupation codes within each of the seven occupation
groups used in past updates to track and document the changes over time
for the CY 2023 GPCI update. As new BLS OEWS data are released, the
availability of specific occupation codes is subject to change, and it
is possible that new codes can be added, changed, or removed from the
BLS OEWS data over time; therefore, we believe it is important to
periodically review and update the occupation groups and codes that are
included in our triennial GPCI updates based on our review. This review
of the BLS OEWS occupation codes is consistent with previous updates.
We use the most updated resource cost data in each area to better
adjust PFS payments for geographic cost differences compared to
national average costs, therefore, we continue to believe that as
updated, more complete BLS OEWS data becomes available, we should
incorporate that data into our methodologies as appropriate.
We note that the seven proxy professional wage categories span
several different industries, including pharmacists and registered
nurses, which demonstrates that the healthcare industry is represented
in those proxy wage categories. We also remind commenters that the work
GPCI captures the relative cost of physician and non-physician
practitioner labor across Medicare payment localities, not absolute
costs. In other words, the proxy professional wages from the BLS OEWS
data are not a proxy for physician wages, but rather, the geographic
variation in proxy professional wages is used as a proxy for the
geographic variation in physician wages. The work GPCI reflects
differences in living and other costs faced by practitioners in
different areas, since other similarly educated professionals face
similar costs. Regarding the commenter's statement that information
regarding correlation should be provided, we note that including
physician wage data in the work GPCI would potentially introduce some
circularity, therefore we remind commenters that, consistent with our
longstanding practice, a set of proxy occupation groups representing a
variety of highly educated professionals are used in the work GPCI
calculation. As discussed in previous rulemaking in response to
commenters' concerns with the use of unrelated proxy data for physician
wages, specifically that MedPAC studies have confirmed that the data
sources currently relied upon for geographic adjustment bear no
correlation to physician earnings, we have stated that we will continue
to consider the possibility of establishing a physician cost report and
requiring a sufficiently large sample of physicians in each locality to
report data on actual costs incurred (81 FR 80264). However, we also
stated that we believed that a physician cost report could take years
to develop and implement, and could be prohibitively expensive (75 FR
73259). We solicited public comment regarding the potential benefits to
be gained from establishing a physician cost report and whether this
approach is appropriate to achieve potentially greater precision in
measuring the relative cost differences in physicians' practices among
PFS localities. We also solicited public comments on the potential
administrative burden of requiring physicians to routinely complete and
submit a cost report. We did not receive any feedback specifically
related to that comment solicitation (76 FR 73088). We note that we do
not claim the proxy professions themselves, or the absolute wages of
the proxy professionals are correlated to physician wages, but rather,
that the geographic variation in proxy professional wages is similar to
the geographic variation in physician wages.
We believe that there would be similar geographic variation if one
were to compare the BLS OEWS data used for the work GPCI with data from
a healthcare provider dataset, as we continue to believe in the
majority of instances, the earnings of physicians will vary among areas
to the same degree that the earnings of other professionals across an
array of industries vary. Further, we welcome opportunities to discuss
data sources that can be used to validate the work GPCIs, similar to
the analysis that we performed for residential and commercial rent data
used for the office rent index.
Comment: One commenter stated that they agree with the use of more
recent wage data, but encouraged CMS to consider the potential effects
of the COVID-19 pandemic on the GPCIs given that the timeframe of the
BLS OEWS data is pre-pandemic and wages have increased drastically
since the start of the pandemic.
Response: We reiterate that the work GPCI captures the relative
cost of physician and non-physician practitioner labor across Medicare
[[Page 69632]]
payment localities, not absolute costs. We note that overall nationwide
wage changes would not be reflected in the work GPCI, but rather, the
geographic variation compared to the national average would be
reflected. We note that we did not use the Census Bureau's 2020 ACS
data in the office rent index for the proposed CY 2023 GPCI update due
to potential COVID-19 pandemic impacts on data, as previously discussed
in the proposed rule. We noted in the proposed rule that we would
analyze the ACS data collected in 2020 and subsequent years that
occurred during the COVID-19 pandemic, and consider using those data
for the next GPCI update after we better understand their integrity and
validity for our purposes. Similarly, we understand that the BLS OEWS
data could be impacted by conditions during the COVID-19 pandemic,
therefore, we will perform similar analyses on the BLS OWES data for
the next GPCI update.
Comment: A few commenters stated that the GPCIs for Hawaii do not
account for the unique costs of providing medical services in Hawaii
and that this will lead to an accelerating shortage of health care
providers across the state of Hawaii. The commenter stated that the 1.5
work GPCI floor for Alaska, and the 1.0 PE GPCI floor for the Frontier
States should serve as a basis for reevaluating the cost of providing
medical services in Hawaii. The commenter stated that the GPCIs should
be adjusted to reflect a factor at least equal to Alaska's work GPCI.
Another commenter requested that Hawaii's GPCIs be increased for the
cost of rent and supplies in Hawaii. One commenter stated that Hawaii's
unique geography makes providing care more expensive and that the cost
of living ranks amongst the highest in the nation, and the data used by
CMS do not reflect the cost of living.
Response: We reiterate that the GPCIs, in particular the work GPCI
and the PE GPCI to which the commenters refer, are based on nationally-
representative and publicly-available wage data from the BLS OEWS for
the work GPCI and employee wage and purchased services components of
the PE GPCI, and the Census Bureau's ACS data for the rent index
component of the PE GPCI. The GPCIs are a measure of relative resource
cost differences among localities compared to the national average as
informed by the data (not a measure of absolute costs). We remind
commenters that the work GPCI value for Alaska is not based on the data
for that State, instead section 1848(e)(1)(G) of the Act sets a
permanent 1.5 work GPCI floor for Alaska. Similarly, section
1848(e)(1)(I) of the Act sets a permanent PE GPCI floor of 1.0 for the
Frontier States.
Comment: One commenter stated that it disputes the claim that the
equipment, supplies, and miscellaneous expenses component of the PE
GPCI do not vary by geographic area. The commenter states that small
specialty practices in rural communities do not have the volume to
negotiate with the national suppliers, particularly for specialty
testing, for which there are only a few places to get the specialty
supplies. The commenter states that prices are typically presented by
the supplier based on volume, and suppliers rarely compromise on order
minimums for rural providers. The commenter also noted that many
medical supplies have expiration dates, and rural areas struggle to
utilize the supplies prior to their expiration dates because of lower
volume and large supply shipments based on a supplier's order minimum.
The commenter expressed concern with access to urgent and direct
patient care services because the national corporations and
laboratories will not provide these low paying services in rural areas.
Response: With regard to the supplies, equipment, and miscellaneous
expense cost index component of the PE GPCIs, we note that we made no
proposals regarding our current policy for this component of the PE
GPCI. We have stated that we believe there is a national market for
these items and there is not significant geographic variation in those
costs, and as such we assign a value of 1.00 for this component for
each locality, consistent with the national average. The commenter did
not provide any data or information to quantify the variation of costs
of supplies, the amount of supplies lost to expiration dates, or
national suppliers' order minimums in contrast to a rural specialty
practice's demand for these supplies. We encourage the commenter and
other interested parties to submit data supporting their assertions for
consideration in future rulemaking; specifically, we would be
interested in information regarding potential data sources for shipping
costs and the costs of medical equipment and supplies for different
geographic regions. Ideally, the potential data sources are accessible
to the public, available on a national basis for both urban and rural
areas, and updated regularly. Similarly, we have previously attempted
to locate data sources specific to geographic variation in shipping
costs, and we found no comprehensive national data source for this
information, and therefore, we have not been able to quantify variation
in costs specific to islands or rural communities.
Comment: A few commenters stated that they do not believe that
local taxes are accounted for in the GPCIs, such as a general excise
tax that is applied to medical services provided in a State.
Response: We note that costs associated with practicing in a
particular locality are accounted for in the data that underpin the
GPCI calculations. Therefore, we disagree with the commenter's
statement that the GPCIs do not account for geographic differences in
taxes.
Comment: Two commenters stated that there is a lack of transparency
into the GPCI data and methodology used to derive the GPCIs. One
commenter stated that they cannot accurately validate CMS' GPCI
calculations because there is little transparency and access to the
data and methods used. The commenter stated that they submitted a
comment on the CY 2022 Physician Fee Schedule proposed rule urging CMS
to provide more transparency into the GPCI calculations in general,
including a more detailed description of the step-by-step methodology
and the specific data files used to derive the GPCIs. In addition to
making the RVUs by county available, the commenters urged CMS to make
available the source data for the work GPCI by county, the source data
for each component of the practice expense GPCI, and all budget
neutrality adjustments and calculations.
The commenters stated that CMS provided these data prior to 2020
and that they used it to reproduce and validate the CMS methodology for
calculating the GPCIs each year. One commenter stated that they have
identified substantial errors in previous proposed rules which CMS has
swiftly corrected. The commenters stated that it is important that CMS
provide more detailed information related to this critical component of
the PFS in the proposed rule in order for the public to reproduce and
validate the GPCIs. The commenters stated that the information should
be published with the proposed rule just as CMS provides the practice
expense RVUs, but with the specific data files.
Response: We refer readers to the step-by-step instructions
provided in the final report, ``Final Report for the CY 2023 Update of
GPCIs and MP RVUs for the Medicare PFS,'' on our website located under
the supporting documents section for the CY 2023 PFS final rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. We also refer readers to Table 4.A.1:
Summary of Elements Required for GPCI Calculation
[[Page 69633]]
in the final report, and the previous discussion, for the data sources
used for the work GPCI and each component of the practice expense GPCI.
As noted in the proposed rule, and as previously stated in this final
rule, we discuss the years and timeframes of data used from each
source. We note that we provide web links to the publicly-available
data sources used in this GPCI update, the methodological parameters,
as well as an overview of how we develop each GPCI component in the
final report. This practice is consistent with previous updates. We
also note that the budget neutrality adjustment and statutory floors
applied after the budget neutrality adjustment are detailed in the
note, ``CY 2023 GPCI Update Note_County_Data,'' on our website located
under the supporting documents section for the CY 2023 PFS proposed and
final rules at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Regarding the interested parties' comment on the CY 2022 proposed
rule urging CMS to provide more transparency on the GPCI calculations,
including a more detailed description of the step-by-step methodology
and the specific data used to derive the GPCIs, we note that we did not
make any proposals relating to the GPCIs in the CY 2022 proposed rule,
so did not solicit or respond to public comments on that rule regarding
GPCIs. However, we remind commenters that, in response to the
commenters' concerns expressed in rulemaking for the CY 2020 GPCI
update, we included more detailed steps in the final report, ``Final
Report for the CY 2020 Update of GPCIs and MP RVUs for the Medicare
Phys Fee Sched_v19Feb2020'', which is available on the CMS website
under the downloads section of the CY 2020 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeeSched/index.html, to assist interested parties in navigating these data.
Additionally, as part of our ongoing commitment to transparency, we
post the county-level data that we use to develop the proposed GPCIs,
which allows interested parties to further examine and replicate our
GPCI methodology. This file is available on the CMS website on our
website under the Downloads section, titled ``CY 2023 Proposed Rule
GPCI County-Level Data File.'' We believe that we sufficiently
addressed previous commenters concerns for the CY 2023 GPCI update in
the proposed rule and aforementioned CY 2020 and CY 2023 interim and
final reports.
Comment: Some commenters that addressed the proposed rebased and
revised MEI supported the proposed delayed implementation of the
updated MEI in the PE GPCI and PFS ratesetting for CY 2023, but we note
that most commenters specifically commented on the data and
methodologies proposed in section II.M. of the proposed rule, rather
than the proposed delayed implementation, as proposed in sections II.B.
and II.G. of the proposed rule. One commenter expressed concern with
the geographic redistribution that could potentially occur with
implementation of the rebased and revised MEI cost share weights used
in the PE GPCI. The commenter stated that when CMS proposes to modify
the weights of the practice expense categories (employee compensation,
office rent, purchased services and equipment/supplies/other) within
the practice expense GPCI, a significant reduction in the weight of
office rent could lead to reductions in the payment to urban sites and
increases to payment in rural areas and states with a single GPCI. The
commenter urged CMS to also consider the impact of implementation of
the rebased and revised MEI cost share weights for geographical areas
with relatively high malpractice premiums, given the decreased weight
of PLI in the proposed rebased and revised MEI.
Response: We thank the commenters for the support of our proposed
delayed implementation of the rebased and revised MEI weights for the
GPCIs and PFS ratesetting for CY 2023. We note that we address specific
comments regarding the rebased and revised MEI in section II.M. of this
final rule. We also note that we provided alternate Addenda D and E to
show the CY 2023 GPCIs and summarized GAFs if the rebased and revised
MEI cost share weights proposed in section II.M. of the proposed rule
were incorporated to weight the proposed CY 2023 PE GPCIs (for
comparison to Addenda D and E with the proposal to maintain the current
2006-based MEI cost share weights for the PE GPCIs). We refer readers
to the discussion of the impacts of the alternative considered (to
implement the proposed rebased and revised MEI in the proposed CY 2023
PE GPCI) in section VI. (2. Alternatives Considered for the Practice
Expense (PE) Geographic Practice Cost Index (GPCI)) of the proposed
rule. We remind commenters that the implementation of the proposed
rebased and revised MEI would only impact the PE GPCI (and GAFs, as the
PE GPCI factors into the calculation of the GAF), as the MEI cost share
weights are only used in the GPCIs to weight the four components of the
PE GPCI. Therefore, the implementation of the rebased and revised MEI
would not impact the work or MP GPCIs. We refer readers to the
discussion of the impacts of the alternative considered (to implement
the proposed rebased and revised MEI in CY 2023 ratesetting) in section
VI. (1. Alternatives Considered for Adjusting RVUs To Match PE Share of
the Medicare Economic Index (MEI)) of the proposed rule for impacts of
decreased PLI weight in the proposed rebased and revised MEI on PFS
ratesetting.
Comment: One commenter expressed appreciation for CMS' efforts to
analyze the commercial rent data sources as alternatives considered for
the residential rent data used in the practice expense GPCI. The
commenter stated that they believe the criteria applied to evaluate
alternative sources of rent data were appropriate and encouraged CMS to
continue this ongoing effort.
Response: We thank the commenters for the support of our efforts
and encourage commenters to submit information regarding potential data
sources for our consideration in future rulemaking. We note that our
efforts are ongoing to identify a publicly-available, robust,
nationally representative commercial rent data source that could be
made available to CMS for this purpose. Further, we welcome
opportunities to discuss such data sources with interested parties and
to incorporate such data, as appropriate, in the GPCI calculation
process.
After considering the public comments, we are finalizing the CY
2023 GPCI update, and the methodological refinements, as proposed. As
discussed previously in this section of the final rule, we are
finalizing to identify the Los Angeles-Long Beach-Anaheim MSA,
containing Orange County and Los Angeles County, by one unique locality
number, 18, and the San Francisco-Oakland-Berkeley MSA containing San
Francisco, San Mateo, Alameda, and Contra Costa counties by one unique
locality number, 05, as proposed. As noted above, there will be no
changes to the existing locality numbers 05, 06, 08, 18, or 26 for CY
2023 due to timing constraints relating to the operationalization of
these changes. As noted above, we intend to operationalize these
finalized changes for CY 2024. We note that these changes, when
operationalized, do not have any payment implications under the PFS. As
a result, the final CY 2023 GPCIs and summarized GAFs in Addenda D and
E to this final rule do not reflect the California locality changes as
finalized, as there will be no
[[Page 69634]]
changes to the existing locality numbers 05, 06, 08, 18, or 26 for CY
2023, and note that the changes will be reflected in Addenda D and E
for CY 2024 when the finalized changes are operationalized.
H. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that valuations for each
service under the PFS be composed of three components: work, practice
expense (PE), and malpractice (MP) expense. As required by section
1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are
resource based. Section 1848(c)(2)(B)(i) of the Act also requires that
we review, and if necessary adjust, RVUs no less often than every 5
years. In the CY 2015 PFS final rule with comment period (79 FR 67591
through 67596), we implemented the third review and update of MP RVUs.
For a comprehensive discussion of the third review and update of MP
RVUs, see the CY 2015 PFS proposed rule (79 FR 40349 through 40355) and
final rule with comment period (79 FR 67591 through 67596). In the CY
2018 PFS proposed rule (82 FR 33965 through 33970), we proposed to
update the specialty-level risk factors, used in the calculation of MP
RVUs, prior to the next required 5-year update (CY 2020), using the
updated MP premium data that were used in the eighth Geographic
Practice Cost Index (GPCI) update for CY 2017; however, the proposal
was ultimately not finalized for CY 2018.
We consider the following factors when we determine MP RVUs for
individual PFS services: (1) specialty-level risk factors derived from
data on specialty-specific MP premiums incurred by practitioners; (2)
service-level risk factors derived from Medicare claims data of the
weighted average risk factors of the specialties that furnish each
service; and (3) an intensity/complexity of service adjustment to the
service-level risk factor based on either the higher of the work RVU or
clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs
were only updated once every 5 years, except in the case of new and
revised codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjusted (or scaled) the
MP RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code was 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach, the same risk factor
(RF) was applied for the new/revised code and source code, but the work
RVU for the new/revised code was used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk
for intensity and complexity (using the work RVU or clinical labor
RVU). We also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. Under
this approach, for new and revised codes, we generally assign a
specialty-level risk factor to individual codes based on the same
utilization assumptions we make regarding specialty mix we use for
calculating PE RVUs and for PFS budget neutrality. We continue to use
the work RVU or clinical labor RVU to adjust the MP RVU for each code
for intensity and complexity. In finalizing this policy, we stated that
the specialty-level risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews.
Section 1848(e)(1)(C) of the Act requires us to review, and if
necessary, adjust the GPCIs at least every 3 years. In the CY 2020 PFS
final rule with comment period, we implemented the fourth review and
update of MP RVUs, and we also conducted the statutorily required 3-
year review of the GPCIs. For a comprehensive discussion of the fourth
review and update of MP RVUs, see the CY 2020 PFS proposed rule (84 FR
40504 through 40510) and final rule with comment period (84 FR 62606
through 62615). The MP premium data used to update the MP GPCIs are the
same data used to determine the specialty-level risk factors, which are
used in the calculation of MP RVUs. Therefore, for the CY 2020 update
of MP RVUs we finalized a policy to align the update of MP premium data
with the update to the MP GPCIs to increase efficiency. Effective
beginning in CY 2020, our policy is to review, and if necessary update,
the MP RVUs at least every 3 years, similar to our review and update of
the GPCIs.
2. Methodology for the Revision of Resource-Based Malpractice (MP) RVUs
a. General Discussion
As discussed in the CY 2023 PFS proposed rule (87 FR 46016), we
calculated the MP RVUs that we proposed for CY 2023 using updated MP
premium data obtained from State insurance rate filings. We used a
calculation methodology for the CY 2023 review and update of resource-
based MP RVUs that largely parallels the process used in the CY 2020
update; however, we proposed to incorporate some methodological
refinements, which we described in the proposed rule. The MP RVU
calculation requires us to obtain information on specialty-specific MP
premiums that are linked to specific services, and using this
information, we derive relative risk factors (RFs) for the various
specialties that furnish a particular service. Because MP premiums vary
by State and specialty, the MP premium information must be weighted
geographically and by specialty. The MP RVUs that we proposed were
calculated using four data sources:
MP premium data presumed to be in effect as of December
31, 2020;
CY 2020 Medicare payment and utilization data;
Higher of the CY 2022 final work RVUs or the clinical
labor portion of the direct PE RVUs; and
CY 2022 MP GPCIs.
We used the higher of the CY 2022 final work RVUs or clinical labor
portion of the direct PE RVUs in our calculation to develop the CY 2023
proposed MP RVUs while maintaining overall PFS budget neutrality.
Similar to the CY 2020 update, the proposed MP RVUs were calculated
using specialty-specific MP premium data because they represent the
expense incurred by practitioners to obtain MP insurance as reported by
insurers. For CY 2023, the most current MP premium data available, with
a presumed effective date of no later than December 31, 2020, were
obtained from insurers with the largest market share in each State. We
identified insurers with the largest market share using the National
Association of Insurance Commissioners (NAIC) market share report. This
annual
[[Page 69635]]
report provides State-level market share for entities that provide
premium liability insurance (PLI) in a State. Premium data were
downloaded from the System for Electronic Rates & Forms Filing Access
Interface (SERFF) (accessed from the NAIC website) for participating
States. For non-SERFF States, data were downloaded from the State-
specific website (if available online) or obtained directly from the
State's alternate access to filings. For SERFF States and non-SERFF
States with online access to filings, the 2020 market share report was
used to select companies. These were the most current data available
during the data collection and acquisition process.
MP insurance premium data were collected from all 50 States, and
the District of Columbia. Efforts were made to collect filings from
Puerto Rico; however, no recent filings were submitted at the time of
data collection, and therefore, filings from the previous update were
used. Consistent with the CY 2020 update, no filings were collected for
the other U.S. territories: American Samoa; Guam; Virgin Islands; or
Northern Mariana Islands. MP premiums were collected for coverage
limits of $1 million/$3 million, mature, claims-made policies (policies
covering claims made, rather than those covering losses occurring,
during the policy term). A $1 million/$3 million liability limit policy
means that the most that would be paid on any claim is $1 million and
the most that the policy would pay for claims over the timeframe of the
policy is $3 million. Adjustments were made to the premium data to
reflect mandatory surcharges for patient compensation funds (PCF, funds
used to pay for any claim beyond the State's statutory amount, thereby
limiting an individual physician's liability in cases of a large suit)
in States where participation in such funds is mandatory.
Premium data were included for all physician and nonphysician
practitioner (NPP) specialties, and all risk classifications available
in the collected rate filings. Although premium data were collected
from all States, the District of Columbia, and previous filings for
Puerto Rico were utilized, not all specialties had distinct premium
data in the rate filings from all States. In the CY 2020 PFS final rule
(84 FR 62607 through 62610), we finalized methodological improvements
that expanded the specialties and amount of filings data used to
develop the proposed risk factors, which are used to develop the
proposed MP RVUs.
b. Methodological Refinements
For the CY 2023 update, we proposed the following methodological
improvements to the development of MP premium data:
(1) Improving our current imputation strategy to develop a more
comprehensive data set when CMS specialty names are not distinctly
identified in the insurer filings, which sometimes use unique specialty
names or do not include all CMS specialties.
In instances where insurers report data for some (but not all)
specialties that explicitly corresponded to a CMS specialty, where
those data were missing, we finalized in the CY 2020 final rule (84 FR
62607 through 62610) to use partial imputation based on available data
to establish what the premiums would likely have been had that
specialty been delineated in the filing. In instances where there were
no data corresponding to a CMS specialty in the filing, we finalized a
policy to use total imputation to establish premiums for that
specialty. We proposed to further refine our strategy for imputing risk
factor values for specialties that have incomplete data during the data
collection process by using rates mapped from the more commonly
reported specialty within risk class as opposed to excluding
underrepresented filing data.
For example, Hospice and Palliative Care is typically assigned the
same risk class as Internal medicine. Rather than excluding Hospice and
Palliative Care because there is insufficient filing data, we would use
Internal Medicine rates in filings that did not explicitly report
Hospice and Palliative Care. For the CY 2020 update, commenters
requested that we continue to improve our data collection process to
ensure that as much specialty-specific data as possible are used to
calculate risk factors. Therefore, we proposed to utilize this small
improvement for collecting risk value input data in the future, as this
retains as much data as possible and maps specialties more
intentionally.
(2) Creation of a risk index for the calculation of MP RVUs.
We proposed to utilize a true MP risk index as opposed to derived
risk factors when calculating MP RVUs. Historically, we have used risk
factors, which is a ratio of a specialty's national average premium to
a single referent specialty's national average premium. This
denominator has typically been based on the national average premium
for the Allergy/Immunology specialty, which has had the lowest average
premium for 2017 and 2020. As proposed, the risk index would be
calculated as a ratio of the specialty's national average premium to
the volume-weighted national average premium across all specialties. We
discussed that we believe the change would increase consistency with
the calculation of MP RVUs, so that changes in the MP risk index
reflect changes in payment, as opposed to changes relative only to the
specialty with the lowest national average premium. We noted that we
believe that this definitional change to risk index does not impact the
pricing of services in the PFS since it does not change relative risk
across specialties, and MP RVUs are rescaled for purposes of budget
neutrality to be equal to the overall pool of MP RVUs. Readers can
refer to the section of the proposed rule entitled, ``Application of BN
to Adjustments of RVUs'' for a discussion of our budget neutrality
process.
c. Steps for Calculating Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 PFS final rule with
comment period (79 FR 67591), along with the proposed methodological
improvements. The specialty-weighted approach bases the MP RVUs for a
given service on a weighted average of the risk index of all
specialties furnishing the service. This approach ensures that all
specialties furnishing a given service are reflected in the calculation
of the MP RVUs. The steps for calculating the MP RVUs are described
below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area MP premiums for each specialty are mapped to
the county level. The specialty premium for each county is then
multiplied by its share of the total U.S. population (from the U.S.
Census Bureau's 2015-2019 American Community Survey (ACS) 5-year
estimates). This is in contrast to the method used for creating
national average premiums for each specialty in the 2015 update; in
that update, specialty premiums were weighted by the total RVU per
county, rather than by the county share of the total U.S. population.
We referred readers to the CY 2016 PFS final rule with comment period
(80 FR 70909) for a discussion of why we have adopted a weighting
method based on share of total U.S. population. This calculation is
then divided by the average MP GPCI across all counties for each
specialty to yield a normalized national average premium for each
specialty. The specialty premiums are normalized for geographic
[[Page 69636]]
variation so that the locality cost differences (as reflected by the
2022 GPCIs) would not be counted twice. Without the geographic
variation adjustment, the cost differences among fee schedule areas
would be reflected once under the methodology used to calculate the MP
RVUs and again when computing the service specific payment amount for a
given fee schedule area.
Step (2): Determine which premium service risk groups to use within
each specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. These premium classes are
designed to reflect differences in risk of professional liability and
the cost of MP claims if they occur. To account for the presence of
different classes in the MP premium data and the task of mapping these
premiums to procedures, we calculated a distinct risk index for
surgical, surgical with obstetrics, and nonsurgical procedures where
applicable. However, the availability of data by surgery and non-
surgery varied across specialties. Historically, no single approach
accurately addressed the variability in premium class among
specialties, and we previously employed several methods for calculating
average premiums by specialty. These methods are discussed below.
Developing Distinct Service Risk Groups: We determined that there
were sufficient data for surgery and non-surgery premiums, as well as
sufficient differences in rates between classes for 17 specialties
(there were 15 such specialties in the CY 2020 update). These
specialties are listed in Table 26. The CY 2023 update uses the same
structure of specialty/service risk group as the previous update except
that Unknown Physician Specialty (99) is now divided into surgery and
non-surgery groups. We were able to collect an expanded amount of
premium data for this specialty relative to the previous update, and
this service risk group structure change is reflective of the patterns
observed in the most current premium data. For all other specialties
(those that are not listed in Table 32) that typically do not
distinguish premiums as described above, a single risk index value was
calculated, and that specialty risk index value was applied to all
services performed by those specialties. For further discussion of the
information contained in Table 26, refer to ``Final Report for the CY
2023 Update of GPCIs and MP RVUs for the Medicare Physician Fee
Schedule'' Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
BILLING CODE 4150-28-P
[GRAPHIC] [TIFF OMITTED] TR18NO22.060
Step (3): Calculate a risk index for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty-level risk
index. These risk index values are calculated by dividing the national
average premium for each specialty by the volume-weighted national
average premium across all specialties. For specialties with sufficient
surgical and non-surgical premium data, we calculated both a surgical
and non-surgical risk index value. Similarly, for specialties with rate
filings that distinguished surgical premiums with obstetrics, we
recognized that service-risk subgroup of the specialty and calculated a
separate surgical with obstetrics risk index value.
Table 33 shows the risk index values by specialty type and service
risk group.
[[Page 69637]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.061
[[Page 69638]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.062
BILLING CODE 4150-28-C
Step (4): Calculate MP RVUs for each CPT/HCPCS code.
Resource-based MP RVUs were calculated for each CPT/HCPCS code that
has work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective CPT/HCPCS
code. This
[[Page 69639]]
percentage was then multiplied by each respective specialty's risk
index value as calculated in Step 3. The products for all specialties
for the CPT/HCPCS code were then added together, yielding a specialty-
weighted service specific risk index reflecting the weighted MP costs
across all specialties furnishing that procedure. The service specific
risk index was multiplied by the greater of the work RVU or clinical
labor portion of the direct PE RVU for that service, to reflect
differences in the complexity and risk-of-service between services.
Impacts of expanded data collection: As we discussed in the
proposed rule, we proposed important methodological improvements to our
process for calculating MP RVUs. The improvements were in response to
comments from interested parties suggesting that we continue to improve
data collection to ensure that we use as much specialty-specific data
as possible to reflect the most accurate trends in malpractice
premiums. When we do not have sufficient premium data for a specialty,
our practice has been to use the data from the specialty with the
lowest premium. As discussed in the proposed rule, we now have
specialty-specific data for many more specialties. However, although
the newly captured specialty-specific premium data are more accurate,
the new data produce premiums and risk index values that are
significantly lower for some specialties than the ones we applied in
the absence of sufficient specialty-specific data.
We acknowledged that this reduction in premiums and risk index
value is expected to negatively impact payment for services furnished
by those specialties that are affected by the improved data collection
process. Based on our analyses of the new risk index data, we
identified an impact threshold to guide how we could integrate the new
information into our calculations and minimize the impact on affected
specialties. Specifically, we identified a reduction of approximately
\1/3\ to the risk index calculated for specialties based on the new
specialty-specific premium data compared to the information we had
previously used. To mitigate the negative impact on affected
specialties, promote payment stability, and prevent potential
reductions in access to services for beneficiaries, for specialties for
which the use of newly available premium data would result in a 30
percent or greater reduction in the risk index for CY 2023 as compared
to the current risk index value for CY 2022, we proposed to phase in
the reduction in MP RVUs over the 3 years that precedes the next
update, by \1/3\ of the change in MP RVUs for those specialties in each
year that have a 30 percent or more threshold reduction in risk index
value as a result of the update. For a detailed explanation of how the
phase-in will be applied per specialty, a file is available on our
website under downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. As proposed, the
phase-in is similar to the 2-year phase-in required under section
1848(e)(1)(C) of the Act for changes to the GPCIs when it has been more
than one year since the last changes. We proposed to phase in the
reduction in MP RVUs over 3 years rather than 2 years because the MP
risk index values are updated every 3 years. The list of specialties
that would be subject to the phase-in under the proposed policy, and
the corresponding risk index values for each specialty is available on
our website under downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Low volume service codes: As we discussed in the proposed rule, for
low volume service codes, we used the list of expected specialties who
may perform a service instead of the claims-based specialty mix when
calculating MP RVUs. We finalized this approach in the CY 2018 PFS
final rule to address concerns from interested parties about the year-
to-year variability in PE and MP RVUs for low volume services (which
also includes no volume services). (82 FR 53000 through 53006). Low
volume codes are codes that have 100 or fewer allowed services for a
year. These service-level overrides are used to determine the expected
specialty for low volume procedures for both PE and MP.
In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also
finalized our proposal to eliminate general use of an MP-specific
specialty-mix crosswalk for new and revised codes. However, we
indicated that we would continue to consider, in conjunction with
annual recommendations, specific recommendations regarding specialty
mix assignments for new and revised codes, particularly in cases where
coding changes are expected to result in differential reporting of
services by specialty, or where the new or revised code is expected to
be low-volume. Absent such information, the specialty mix assumption
for a new or revised code would derive from the analytic crosswalk in
the first year, followed by the introduction of actual claims data,
which is consistent with our approach for developing PE RVUs.
For CY 2023, we solicited public comment on the list of expected
specialties. As noted in the proposed rule, the proposed list of codes
and expected specialties was made available on our website under
downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
We received public comments on the list of expected specialties.
The following is a summary of the comments we received and our
responses.
Comment: Commenters suggested additional CPT codes to be added to
the Expected Specialty Overrides for Low Volume Service Codes list.
Response: We appreciate commenters' suggested additions of low
volume service CPT codes to the Expected Specialty Overrides for Low
Volume Service Codes list. We refer readers to the PE RVU Methodology
section of this final rule for a discussion regarding the expected
specialties list and the suggested additions for CY 2023.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. Thus, the last step is to adjust for relativity by
rescaling the proposed MP RVUs so that the total proposed resource-
based MP RVUs are equal to the total current resource-based MP RVUs
scaled by the ratio of the pools of the proposed and current MP and
work RVUs. This scaling is necessary to maintain the work RVUs for
individual services from year to year while also maintaining the
overall relationship among work, PE, and MP RVUs.
Specialties Excluded from Ratesetting Calculation: In section II.B.
of the proposed rule, Determination of Practice Expense Relative Value
Units, we discussed specialties that are excluded from ratesetting for
the purposes of calculating PE RVUs. We proposed to treat those
excluded specialties in a consistent manner for the purposes of
calculating MP RVUs. We noted that all specialties are included for
purposes of calculating the final BN adjustment. The list of
specialties excluded from the ratesetting calculation for the purpose
of calculating the PE RVUs that we proposed to also exclude for the
purpose of calculating MP RVUs is available in section II.B. of the
proposed rule, Determination of Practice Expense Relative Value Units.
The resource-based MP RVUs are shown in Addendum B, which is available
on the CMS website under the downloads section of the CY 2023 PFS final
rule at
[[Page 69640]]
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Because a different share of the resources involved in furnishing
PFS services is reflected in each of the three fee schedule components,
implementation of the resource-based MP RVU update will have much
smaller payment effects than implementing updates of resource-based
work RVUs and resource-based PE RVUs. On average, work represents about
50.9 percent of payment for a service under the fee schedule, PE about
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change
in PE RVUs or work RVUs for a service would result in a change in
payment of about 11 to 13 percent. In contrast, a corresponding 25
percent change in MP values for a service would yield a change in
payment of only about 1 percent. Estimates of the effects on payment by
specialty type is detailed in section VII. of the proposed rule, the
Regulatory Impact Analysis.
Additional information on our methodology for updating the MP RVUs
is available in the ``Final Report for the CY 2023 Update of GPCIs and
MP RVUs for the Medicare Physician Fee Schedule,'' was made available
on the CMS website under the downloads section of the CY 2023 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
The following is a summary of the public comments received on the
proposed revisions to the Determination of Malpractice RVUs and our
responses:
Comment: The majority of commenters are in support of the proposed
methodological improvements to our imputation strategy and expanded
data collection efforts to create a risk index rather than risk
factors. In particular, most commenters are pleased with the expanded
data collection efforts that have resulted in increased accuracy for
non-physician practitioner's premium data and a risk index system that
is volume-weighted to the national average premium across all
specialties, rather than allergy/immunology. One commenter requested
that CMS not implement the update to the 2023 MP RVUs, as proposed, due
to concern for an increase in professional liability costs over the
next few years. The commenter noted there could be an increase in
malpractice claims caused by the public health emergency, and
therefore, any negative impacts would be exacerbated.
Response: We thank commenters for their feedback and overall
support. We believe that the negative impacts of this MP update are
relatively modest and we agree with the majority of commenters that
believe that the impacts do not outweigh the benefit of updated and
expanded premium data that yield more accurate professional liability
insurance costs across all specialties. Therefore, we are finalizing
our methodological improvements as proposed.
Comment: A few commenters requested that CMS not implement the
proposed phase-in of risk index values that have decreased by 30
percent or more as a result of the expanded data collection efforts.
These commenters requested that we implement the risk index values in
their entirety for 2023 and noted that there has been a request for
expanded data collection efforts and, therefore, more accurate premium
data for several years. The commenters stated that these changes to
risk index values were anticipated as a result of expanded data
collection, and are relatively minor. Additionally, some commenters
noted that in previous updates to the MP RVU data, CMS has not
implemented a phase-in in response to dramatic reductions in premiums
for a few specialties. One commenter was appreciative of the phase-in
and requested that it be implemented as proposed.
Response: We acknowledge that, for previous MP RVU updates,
reductions in risk index values have not always been phased-in over
time when there is a significant impact to a specific specialty. We
also acknowledge commenters' opinions that changes to risk index values
are anticipated when there are expanded data collection efforts.
However, we remain committed to reducing burdens on practitioners by
maintaining stability in Medicare payment and removing barriers to
access for beneficiaries that could occur as a result of impacts from a
reduction in payment to practitioners. Therefore, we believe it is
important to implement a phase-in for those specialties for which we
observed a large reduction in risk index value. We are finalizing our
MP RVU phase-in strategy as proposed.
Comment: One commenter suggested that CMS make changes to the
specialty data source for a few specialties that they believe are
incorrectly mapped for purposes of data imputation. The commenter also
noted that they would like us to further improve our imputation
methodologies by publishing impacts for all CMS specialties instead of
mapping to related specialties in the regulatory impact table included
in all PFS Federal Register notices. Additionally, the commenter stated
that they would like CMS to work with the RUC to better identify
appropriate cross-walks when necessary. The commenter's requested
changes to mappings are as follows: 19- Oral Surgery (dental only)
(ALL) to Other, 13-Neurology (SURG) to Other, 14- Neurosurgery (ALL) to
Other, 72- Pain Management (ALL) to 11- Internal Medicine, 98-
Gynecologist/oncologist (ALL) to 91-Surgical oncology (ALL), C0-Sleep
medicine (ALL) to 13-Neurology (NO SURG), C7-Advanced heart failure and
transplant cardiology (ALL) to 06-Cardiology (NO SURG), 71- Registered
Dietician to Other, and 42-Certified Nurse Midwife to Other.
Response: We appreciate the commenter's mapping suggestions for
some specialties that require imputation of premium data. We would also
like to reiterate that we will continue to work with all interested
parties to improve the data used for calculating risk index values. We
continue to believe that the regulatory impact table (Table 8.A CMS
Specialty Map into Impact Specialty) of the ``Interim Report for the CY
2023 Update of GPCIs and MP RVUs for the Medicare Physician Fee
Schedule'' is a useful tool to assist us with mapping premium data when
specialty specific premium data are not included in a filing. However,
as we discussed in the proposed rule and above, we have adopted
policies to improve our data imputation and employ partial imputation
based on available data to approximate the premiums when we do not have
complete specialty specific premium data, as reflected in Table 8.C
(Source Specialty/Service Risk Group for Imputation for Updated PLI
Premium Data) of the ``Interim Report for the CY 2023 Update of GPCIs
and MP RVUs for the Medicare Physician Fee Schedule.''. In particular,
71- Registered Dietician, (for purposes of impacts) is mapped to Other
in Table 8.A. 42- Certified Nurse Midwife is also mapped to Obstetrics/
Gynecology. However, we were able to collect sufficient premium data
such that partial imputation was not required and we were able to use
the actual premium data to formulate a risk index value for both
specialties. Therefore, we disagree with commenters and will not re-map
Registered Dietician or Certified Nurse Mid-wife in Table 8.A (CMS
Specialty Map into Impact Specialty), as no mapping for premium data
was required. We believe that the expanded premium data collected is an
accurate representation of those specialty's premiums for this update.
Therefore, they are also not required to be listed in Table 8.C. for
specialties that require partial imputation. Additionally, 19-
[[Page 69641]]
Oral Surgery (dental only) is mapped to Maxillofacial surgery for
purposes of data imputation. We note that when collecting premium data,
Oral Surgery frequently appears together with Maxillofacial surgery.
Without additional information to change this mapping and in
consideration of their frequency of reporting together, we do not
believe it is appropriate to change the mapping for this update.
Additionally, without additional information to support a change in
mapping, we do not believe it is necessary to change the mapping for
13-Neurology (SURG) and 14-Neurosurgery (ALL). We note that 13-
Neurology (SURG) and 14-Neurosurgery (ALL) have had the same risk value
for the last two updates of the MP RVUs. For the other requested re-
mappings listed above, after further review and consideration of the
commenters requests, we are finalizing a change for the following
specialties for purposes of partial imputation as reflected in Table
8.C.: 72- Pain Management (ALL) to 11- Internal Medicine (ALL), 98-
Gynecologist/oncologist (ALL) to 91- Surgical oncology (ALL), C0-Sleep
medicine (ALL) to 13-Neurology (NO SURG), and C7- Advanced heart
failure and transplant cardiology (ALL) to 06- Cardiology (NO SURG).
Comment: Several commenters alerted CMS to a technical ratesetting
error for technical component (TC)-only services. Commenters were
concerned about the ratesetting error causing an inappropriate
redistribution effect within the technical component (TC) and
professional component (26) such that the relationship became inverted
with MP RVUs being drawn away from the 26 services and added to the TC
services. Commenters stated that they believe that this error was
caused by the change to a risk index and an error within ratesetting to
map TC-only services to a 1.00 risk value. Commenters requested that
CMS correct the error or delay implementation of the MP RVU update.
Response: We appreciate commenters bringing to our attention the
error in calculating the proposed MP RVUs for TC-only services. We
agree with commenters that a technical error in our ratesetting system
that mapped all TC-only services to a 1.00 risk value resulted in the
TC and 26 MP RVU distribution error. For the CY 2020 update of the MP
RVUs (84 FR 62606 through 62615), we finalized that we would assign a
risk factor of 1.00, which was the lowest physician specialty risk
factor (allergy/immunology), to TC-only services due to a lack of
sufficient professional liability premium data. For the proposed CY
2023 update of the MP RVUs (87 FR 46016), we stated that, ``When we do
not have sufficient premium data for a specialty, our practice has been
to use the data from the specialty with the lowest premium. We now have
specialty-specific data for many more specialties.'' Our expanded data
collection efforts resulted in sufficient premium data such that we
could directly assign a risk value for TC-only services without the
need for mapping. However, due to a technical error, we continued to
assign a 1.0 risk factor for all TC-only services which resulted in an
incorrect calculation of the proposed MP RVUs for TC-only services. In
consideration of commenters asking us to find a way to resolve the
inappropriate distribution or delay implementation, we are finalizing a
correction to the ratesetting error for the 2023 update of the MP RVUs.
The correction will again map TC-only services to allergy/immunology
for this update, which is a risk index value of 0.430. We believe that
using this risk value will correct the identified error, while also
maintaining as much stability as possible for TC-only services so that
there is not a major shift in value from current MP RVUs for the TC and
26 components. We will continue to re-evaluate the MP RVU methodology
for TC-only services for future updates.
Additional information on our methodology for updating the MP RVUs
is available in the ``Final Report for the CY 2023 Update of GPCIs and
MP RVUs for the Medicare Physician Fee Schedule,'' which is available
on the CMS website under the downloads section of the CY 2023 PFS final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
After consideration of the comments, we are finalizing the CY 2023
update as proposed with a modification to address an error with respect
to the risk values for TC-only services, as indicated above. We are
finalizing our proposal to implement a risk index rather than risk
factors and improve upon our data imputation strategy by mapping to
service risk group/class. We are also implementing a 3-year phase-in
for specialties with a reduction in risk value of 30 percent or more to
reduce burden, maintain stability in reimbursement for practitioners,
and maintain access to services for beneficiaries.
I. Non-Face-to-Face Services/Remote Therapeutic Monitoring (RTM)
Services
Remote Therapeutic Monitoring (RTM) is a family of five codes
created by the CPT Editorial Panel in October 2020, valued by the RUC
at its January 2021 meeting, and finalized for Medicare payment in the
CY 2022 PFS final rule (86 FR 65114 through 65117). The RTM codes
include three PE-only codes and two professional work, treatment
management codes.
In the CY 2022 PFS final rule, we finalized refinements to payment
for the three PE-only RTM codes: CPT code 98975 (Remote therapeutic
monitoring (e.g., respiratory system status, musculoskeletal system
status, therapy adherence, therapy response); initial set-up and
patient education on use of equipment); CPT code 98976 (Remote
therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, therapy adherence, therapy response);
device(s) supply with scheduled (e.g., daily) recording(s) and/or
programmed alert(s) transmission to monitor respiratory system, each 30
days); and CPT code 98977 (Remote therapeutic monitoring (e.g.,
respiratory system status, musculoskeletal system status, therapy
adherence, therapy response); device(s) supply with scheduled (e.g.,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days). We valued the three PE-only
codes by: (1) cross-walking CPT code 98975 to the PE RVU value of CPT
code 99453 (Remote monitoring of physiologic parameter(s) (e.g.,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; set-up and patient education on use of equipment); and by (2)
cross-walking CPT codes 98976 and 98977 to the PE RVU of comparable CPT
code 99454 (Remote monitoring of physiologic parameter(s) (e.g.,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; device(s) supply with daily recording(s) or programmed
alert(s) transmission, each 30 days), a code that includes payment for
the medical device used to collect and transmit data.
For the two RTM treatment management codes, we finalized the RUC-
recommended work RVU of 0.62 for CPT code 98980 (Remote therapeutic
monitoring treatment management services, physician/other qualified
health care professional time in a calendar month requiring at least
one interactive communication with the patient/caregiver during the
calendar month; first 20 minutes) and the RUC-recommended work RVU of
0.61 for its add-on code, CPT code 98981 (Remote therapeutic monitoring
treatment management services, physician/other qualified health care
professional time in a calendar month requiring at least one
interactive communication with the
[[Page 69642]]
patient/caregiver during the calendar month; each additional 20 minutes
(List separately in addition to code for primary procedure)).
We also finalized the RUC-recommended direct PE inputs for the two
treatment management codes without refinement. The direct PE for these
two codes includes clinical labor. According to the supporting
materials in the RUC recommendations that we accepted, CPT code 98980
includes 40 minutes of activities performed by clinical staff while CPT
code 98981 includes 20 minutes of activities performed by clinical
staff as direct practice expenses (PE). The RUC materials describe the
activities of clinical staff who perform the clinical labor involved in
each of these codes as including: communicating with the patient
throughout the month, resolving technology or data transmission
concerns, reviewing data with the billing practitioner, updating and
modifying care plans, and addressing lack of patient improvement. These
activities performed by clinical staff of the billing practitioner
would be considered services provided incident to the services of the
billing practitioner. For more information about ``incident to''
services, see Sec. 410.26.
We expressed concern in the CY 2022 PFS final rule (86 FR 65116)
about the treatment management codes as described by the CPT and RUC.
In particular, we expressed concern about the inclusion of clinical
labor in codes that could be billed by qualified nonphysician
healthcare professionals because Medicare Part B does not include a
benefit for services furnished ``incident to'' the services of some
types of qualified nonphysician healthcare professionals including
CSWs, CRNAs, PTs, OTs, and SLPs. Commenters on the CY 2022 PFS proposed
rule (86 FR 65116) agreed with our assessment and suggested that we
consider developing new coding to resolve the issue. In the CY 2022 PFS
final rule, we finalized a policy that permitted therapists and other
qualified healthcare practitioners to bill the RTM codes. We stated
that where the practitioner's Medicare benefit does not include
services furnished incident to their professional services, the
services described by the codes must be furnished directly by the
billing practitioner or, in the case of a PT or OT, by a therapy
assistant under the billing PT's or OT's supervision.
The commenters also expressed concern about another issue with the
RTM coding that also relates to the clinical labor in the direct PE for
the two treatment management codes (86 FR 65116). The commenters
acknowledged that the clinical labor involved in these codes, that is,
the portion of these services performed by clinical staff incident to
the services of the billing clinician, requires direct supervision by
the billing practitioner. The commenters stated that direct supervision
of clinical staff performing these activities was burdensome, and
suggested that physicians and nonphysician practitioners who can bill
for ``incident to'' services would be unlikely to use the codes if
direct supervision were required. The commenters suggested that we
designate CPT codes 98980 and 98981 as care management services or
alternatively, that we develop HCPCS G codes that would allow the
``incident to'' clinical labor portions of the services to be furnished
under general supervision of the billing physician or nonphysician
practitioner.
Since the CY 2022 PFS final rule was issued, we have remained in
communication with interested parties. Conversations continue to
revolve around the two concerns detailed above related to the clinical
labor in the direct PE for the two RTM treatment management codes, CPT
codes 98980 and 98981. Thus, for CY 2023 we proposed to create four new
HCPCS G codes with one pair of codes aimed at increasing patient access
to remote therapeutic monitoring services and the second pair aimed at
reducing physician and NPP supervisory burden.
In the proposed rule, we noted that we also considered requests
from interested parties to develop a generic device code for RTM, and
that we had decided to wait to develop a generic RTM device code. We
explained that we would seek comment to inform any new coding relating
to devices. Thus, we sought comment about RTM devices that are used to
deliver services that meet the ``reasonable and necessary'' standard
under section 1862(a)(1)(A) of the Act. We sought information related
to the types of data collected using RTM devices, how the data that are
collected solve specific health conditions and what those health
conditions are, the costs associated with RTM devices that are
available to collect RTM data, how long the typical episode of care by
condition type might last, and the potential number of beneficiaries
for whom an RTM device might be used by the health condition type.
Summary of the proposal to develop two HCPCS G codes that allow
certain qualified nonphysician healthcare professionals to furnish RTM
services. As discussed in the proposed rule, we have heard that a
primary reason for developing the RTM codes was to increase beneficiary
access to remote monitoring services by allowing the services to be
furnished by a broad array of qualified nonphysician healthcare
professionals (87 FR 46023 and 46024). However, concerns with the CPT
coding structure related to the inclusion of clinical labor integral to
the professional services have complicated the achievement of those
goals. In the CY 2022 PFS final rule, we finalized a policy that
permitted therapists and other qualified healthcare practitioners to
bill the RTM codes, though we expressed some concerns about the ability
of therapists to bill for these codes because the Medicare benefit does
not include services provided incident to the services of a therapist
(86 FR 65116). We stated that where the practitioner's Medicare benefit
does not include services furnished incident to their professional
services, the services described by the codes must be furnished
directly by the billing practitioner or, in the case of a PT or OT, by
a therapy assistant under the billing PT's or OT's supervision. We
stated that these practitioners could bill CPT codes 98980 and 98981
even when the practitioner's Medicare benefit category did not include
services furnished incident to their professional services as long as
the services were furnished directly by the billing practitioner.
In this year's proposed rule, as a means of increasing beneficiary
access to RTM services, as well as to more clearly define the services
of RTM for qualified nonphysician healthcare practitioners whose
Medicare benefit category does not include services provided incident
to their own services, we proposed to create two new codes that would
expressly facilitate RTM services furnished by qualified nonphysician
healthcare professionals who cannot bill under Medicare Part B for
services furnished incident to their professional services. These codes
would not include ``incident to'' activities in the PE. Neither of the
two proposed new codes included clinical labor inputs in the direct PE.
We also proposed to make the current CPT codes 98980 and 98981 codes
non-payable by Medicare.
We proposed the following two HCPCS G codes:
GRTM3 (Remote therapeutic monitoring treatment assessment
services, first 20 minutes furnished personally/directly by a
nonphysician qualified health care professional over a calendar month
requiring at least one interactive communication with the patient/
caregiver during the month).
GRTM4 (Remote therapeutic monitoring treatment assessment
[[Page 69643]]
services, additional 20 minutes furnished personally/directly by a
nonphysician qualified health care professional over a calendar month
requiring at least one interactive communication with the patient/
caregiver during the calendar month (List separately in addition to
code for primary procedure)).
For CY 2023, we proposed a work RVU of 0.62 for the base code,
HCPCS code GRTM3, which is the RUC-recommended work RVU we established
for CPT code 98980 in the CY 2022 PFS final rule. Similarly, for the
add-on code, HCPCS code GRTM4, we proposed a work RVU of 0.61, which is
the RUC-recommended value we established for CPT code 98981. We
proposed to remove the clinical labor inputs in the direct PE for both
codes, which will facilitate the use of these codes by qualified
nonphysician healthcare practitioners who cannot bill under Medicare
Part B for services furnished incident to their professional services.
See Table 34: Summary of Proposed HCPCS G Codes for Remote Therapeutic
Monitoring Services for more detailed information about the codes.
Additionally, we noted that all the RTM codes including proposed
HCPCS codes GRTM3 and GRTM4 would be designated as ``sometimes
therapy'' codes, which means that the services could be billed outside
a therapy plan of care by physicians and certain NPPs. We noted that
when the services described by proposed HCPCS codes GRTM3 and GRTM4 are
furnished by PTs, OTs, or SLPs, the services would always need to be
furnished under a therapy plan of care. We reminded readers that RTM
services that relate to devices specific to therapy services should
always be furnished under a therapy plan of care regardless of who
provides them. See the Medicare Benefit Policy Manual Chapter 15,
Section 230 for more information about the practice of PT, OT, and SLP.
Summary of the proposal to develop two HCPCS G codes allowing
general supervision of auxiliary personnel. As we described in the
proposed rule, since the CY 2022 PFS final rule was published, we have
continued to hear concerns from interested parties that, as for most
``incident to'' services, the clinical labor activities described in
the direct PE of CPT codes 98980 and 98981 must be furnished under the
direct supervision of the billing practitioner, which imposes burden on
physicians and NPPs who are delivering services to other patients.
Thus, for CY 2023, we proposed to create two HCPCS G codes, one base
code and one add-on code, that include clinical labor activities (that
is, incident to services such as communicating with the patient,
resolving technology concerns, reviewing data, updating and modifying
care plans, and addressing lack of patient improvement) that can be
furnished by auxiliary personnel under general supervision. These two
new G codes, GRTM1 and GRTM2, include physician work and direct PE
inputs as currently described in CPT codes 98980 and 98981 but allow
general supervision of the clinical labor found in the direct PE
inputs. See Table 34: Summary of Proposed HCPCS G Codes for Remote
Therapeutic Monitoring Services for more detailed information about the
codes and use of the codes.
We proposed the following two HCPCS G codes:
HCPCS code GRTM1 (Remote therapeutic monitoring treatment
management services, physician or NPP professional time over a calendar
month requiring at least one interactive communication with the
patient/caregiver during the calendar month; first 20 minutes of
evaluation and management services).
HCPCS code GRTM2 (Remote therapeutic monitoring treatment
management services, physician or NPP professional time over a calendar
month requiring at least one interactive communication with the
patient/caregiver over a calendar month; each additional 20 minutes of
evaluation and management services during the calendar month (List
separately in additional to code for primary procedure).
For CY 2023, we proposed a work RVU of 0.62 for HCPCS code GRTM1,
which reflects the work RVU for CPT code 98980 that we finalized in the
CY 2022 PFS final rule. For HCPCS code GRTM2, we proposed a work RVU of
0.61, which is the RUC-recommended value we finalized for the similar
CPT code 98981. We proposed the direct PE inputs associated with CPT
codes 98980 and 98981 without refinement for HCPCS codes GRTM1 and
GRTM2, respectively. As stated previously, we proposed to make the
current CPT codes 98980 and 98981 codes non-payable by Medicare.
BILLING CODE 4150-28-P
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[GRAPHIC] [TIFF OMITTED] TR18NO22.063
[[Page 69645]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.064
BILLING CODE 4150-28-C
Review of New RTM Device Code: Cognitive Behavioral Therapy Monitoring
(CPT Code 989X6)
During its October 2021 meeting, the CPT Editorial Panel replaced
two Category III codes: 0702T (Remote therapeutic monitoring of a
standardized online digital cognitive behavioral therapy program
ordered by a physician or other qualified health care professional;
supply and technical support, per 30 days) and 0703T (Remote
therapeutic monitoring of a standardized online digital cognitive
behavioral therapy program ordered by a physician or other qualified
health care professional; management services by physician or other
qualified health care professional per calendar month) (e.g.,
respiratory system status, musculoskeletal system status, cognitive
behavioral therapy, therapy adherence, therapy response) with the
Category 1 CPT code 989X6, Cognitive Behavioral Therapy Monitoring
(Remote therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, cognitive behavioral therapy, therapy
adherence, therapy response); initial set-up and patient education on
use of equipment; device(s) supply with scheduled (e.g., daily)
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days). The CPT Editorial Panel
created 989X6 for CY 2023 and deleted Codes 0702T and 0703T.
Also, during the October 2021 meeting, the CPT Editorial Panel
revised the code descriptors for the PE-only RTM codes (that is, CPT
codes 98975, 98976, and 98977) that CMS finalized in the CY 2022 PFS
final rule (86 FR 65114 through 65117) to include ``cognitive
behavioral therapy'' as another example of the type of service
described by the coding. The RUC indicated that it considered this
revision to be editorial.
During the January 2022 RUC review, the definition of new CPT code
989X6 was further refined to read Remote therapeutic monitoring (e.g.,
therapy adherence, therapy response); device(s) supply with scheduled
(e.g., daily)
[[Page 69646]]
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavior therapy, each 30 days). During the RUC review of CPT
code 989X6, specialty societies indicated that the technologies for
this service are still evolving. As a result, there were no invoices
for devices specific to the cognitive behavioral therapy monitoring
services described by the code that could be shared. In response, the
RUC recommended that CPT code 989X6 be contractor priced.
Given the anticipatory nature of this code, we agreed with the RUC
recommendation that this new code should be contractor priced until we
learn more about the devices being used to furnish the service. Thus,
we proposed to accept the RUC recommendation to contractor price CPT
code 989X6, a PE-only device code. There is no professional work
associated with the code. We noted that we would work with our Medicare
Administrative Contractors (MACs) to better understand the kinds of
devices and device costs they are encountering as they review claims
for payment for the new cognitive behavioral monitoring code, CPT code
989X6.
We thanked last year's commenters and the many others who have
contacted us with their questions and ideas. We noted that we
appreciated the continuing dialogue about the remote monitoring codes
and welcomed comments including any additional information that the
medical community and other members of the public believe may provide
further clarity on how remote patient monitoring services are used in
clinical practice, and how they would be most appropriately coded,
billed and valued under the Medicare PFS.
The following is a summary of the public comments received on the
proposed revisions to the Non-Face-to-Face Services/Remote Therapeutic
Monitoring (RTM) Services and our responses:
Comment: A number of commenters provided specific feedback about
our discussion of the purpose and intent of the proposed new codes,
GRTM1-4. In particular, commenters noted that if finalized, the aims of
increasing access to RTM services while reducing burden associated with
use of the codes may not manifest. In particular, some questioned
whether our proposals would result in appropriate levels of payment
that reflect the burden of supervision and coordination of different
levels of clinical staff and skills, including use of auxiliary
personnel, required to furnish RTM services. Some commenters noted that
creating G codes as a means to address various different levels of
effort of clinical staff involved in rendering these services would
possibly create confusion and increase burden; these commenters also
responded that various types of clinical staff activities are already
accounted for in the existing RTM codes. One commenter cited our
finalized policies from last year, expressed confusion about the
complexity and utility of creating a new set of codes, and stated that
CMS should instead modify the level of supervision required for the
existing codes because the supervision requirements are themselves
within our specific delegated authority to adjust.
Response: We thank commenters for the feedback on our proposed GRTM
codes, and note that our response here is consistent with our
discussion of the existing code set in previous rulemaking. In our CY
2022 final rule, we noted that despite our concerns about the
construction of the codes, we believe the services RTM described by the
codes are important to beneficiaries. (86 FR 65116). In this year's
rulemaking, we find similar themes. Commenters remain supportive of our
efforts to enhance access to RTM and RPM services, yet commenters also
continue to raise concerns similar to feedback received on last year's
proposals for RTM. Our proposals for GRTM1-4 drew concern from various
perspectives.
As commenters noted, the existing RTM codes do reflect a broad
range of clinical activities, and use of various levels and involvement
of auxiliary staff. To this point, in the CY 2022 PFS final rule (86 FR
65114 through 65117), we discussed and finalized a policy that permits
therapists and other qualified healthcare professionals to bill the RTM
codes. As noted, the billing rules for the current family of RTM codes
do allow a broader range of clinical activities and varied levels and
involvement of auxiliary staff. We refer readers to our discussion in
the CY 2022 PFS final rule that addresses the RTM family of codes: the
initial set-up and patient education services (CPT code 98975), as well
as the device codes (CPT codes 98976 and 98977), as well as the
treatment management codes (CPT codes 98980 and 98981). There we
explained our thinking and experience with the RTM code family which
led us to this year's proposed G-codes. We reiterate that the general
feedback we have received for RTM codes suggested two possible paths
forward. One path was reflected in the proposal that appeared in this
year's proposed rule; another path is an alternative that we described
in response to comments in the CY 2022 PFS final rule. The alternative
to the creation of new G-codes as we proposed was to instead modify our
supervision policy for services furnished incident to a practitioner's
professional service to require a general level of supervision, rather
than direct supervision, for the existing RTM codes (CPT codes 98975,
98976, 98977, 98980, and 98981) as we have done for certain designated
care management services. We thank commenters for continuing to provide
feedback, and agree with commenters who noted that the current CPT code
descriptions for RTM treatment management encompass a broad range of
practitioners and clinical staff activities. We refer readers to our
discussion in last year's final rule for background on the valuation of
CPT codes 98980 and 98981 (86 FR 65116).
However, we acknowledge that our proposals may have generated
confusion among some interested parties. Based on some of the comments
received, we believe some interested parties may have misinterpreted
our proposed valuation of the G-codes, GTRM-3 and GTRM-4. Specifically,
we received comments that misunderstood our proposed valuation for
GTRM-3 and GTRM-4 to mean that we proposed an across-the-board cut to
payment for all Medicare Part B payment for certain types of non-
physician practitioners that current may bill the RTM treatment
management codes (CPT codes 98980 and 98981). Based on public comments,
we agree that confusion remains about how the new G-codes, if
finalized, would or would not possibly create a chilling effect on the
availability of RTM services.
Comment: Some commenters submitted general feedback regarding the
RTM codes rather than our specific proposals, and stated that
individual practitioners or their employers would not engage in further
investment of time and resources that would be required to implement,
maintain, and support RTM services without better clarity on three main
aspects of our RTM policy. In brief, these comments focused concerns
about the burden associated with maintaining direct supervision for all
auxiliary staff involved in furnishing RTM services, the difficulty of
navigating ambiguity as to the data that must be kept and maintained
for recordkeeping and care coordination, and uncertainty about whether
certain devices would or could be used in light of the first two issues
regarding supervision and recordkeeping requirements. We received
feedback that generally questioned how practitioners should navigate
furnishing RTM services when the requirements
[[Page 69647]]
appeared to create a risk of later needing to return payments after
potential future CMS audits. Some commenters also suggested that CMS
would ``claw back'' payment for these services if an individual
beneficiary received concurrent RTM services from two different
clinicians engaged in separate episodes of care that involved provision
of RTM services for the same beneficiary during the same month, which
is not allowed under current policy. Some commenters also shared
anecdotal evidence that suggests RTM services do or will improve health
equity, and were concerned that our imposition of limitations or
burdensome requirements, or possible payment denials or recovery of
overpayments, may create disincentives that reduce beneficiary access
to RTM services.
Response: We believe that our goals have remained consistent
throughout our efforts to shape RTM and RPM coding and payment policy,
and refer to our CY 2020 (84 FR 62697 through 62698), CY 2021 (85 FR
84542 through 84546), and CY 2022 (86 FR 65114 through 65116) rules for
further background discussion of these goals. In the CY 2023 PFS
proposed rule, we included proposals to address specific issues
relating to the CPT code set for RTM services, and in particular the
RTM treatment management codes (CPT codes 98980 and 98981). We
recognize and appreciate the more generalized concerns raised by these
commenters and will take these comments into consideration for possible
future rulemaking.
Comment: Many commenters requested that CMS reconsider the
proposals because the burden of the proposed GRTM codes would involve a
requirement that certain supply codes (CPT codes 98975 and 98976 or
98977) must be billed prior to furnishing the services reflected in
GRTM1-4. This feedback came from various interested parties, which
included a diverse set of perspectives and roles across the medical
community, various trade associations, many professional societies, and
health IT vendors. In summary, the commenters suggest that the timing
and sequence of proposed requirements for the proposed GRTM codes would
possibly create gaps in care, or delays in access to care.
Some commenters expressed concern about initiating an episode of
RTM services without necessary claims data available to know whether an
existing and overlapping RTM service is being billed for the same
beneficiary for a different episode of care initiated by a different
practitioner in any given month. We received comments from healthcare
providers and vendors that support medical practices expressing concern
about the need to avoid situations where a practitioner may furnish RTM
services, and later be expected to return Medicare payment, if CMS were
to determine that all applicable requirements were not met. These
commenters suggested that such scenarios could result in unstable or
uncertain financial liability. Vendors requested more clarity about the
structure and form of data that would need to be available at the
point-of-care, including claims history that would be necessary to
track a beneficiary's current use of RTM services and assess whether
the beneficiary would be eligible to begin any additional RTM service.
Some in the clinical community suggested that it would be difficult or
impossible to track the necessary information to know whether a
beneficiary is eligible for RTM services.
Commenters who raised these concerns explained that CMS' proposals
may cause delays in delivery of necessary care, or unduly limit access.
Further, commenters reiterated feedback we had received in previous
rulemaking that CMS should allow multiple, concurrent RTM services for
an individual beneficiary, which would not be permitted under existing
policies or under our proposed policy changes, if finalized.
Response: We thank the commenters for sharing their views and
appreciate the questions and concerns they presented. We continue to
gather information and experience with coding and payment policies for
RTM services. We will continue our discussions with healthcare
providers and MACs to understand opportunities and challenges related
to our policies and claims processing for RTM codes, and consider the
need for further guidance, practitioner education, program
instructions, or further rulemaking regarding these services.
Comment: Commenters who responded to our request for feedback on
the possible future development of a generic RTM device code noted that
a generic RTM device code would allow a broader range of types of
remote therapy monitoring, beyond the existing codes that allow payment
for services that address respiratory system status, musculoskeletal
status, and therapy adherence, or therapy response. Some commenters
stated that a path forward is unclear because certain approved devices
monitor conditions that presently have no available RTM code (for
example, specific neurological conditions), and requested that we
consider establishing in the future a mechanism to submit data on these
types of devices and conditions that any clinical specialty. Commenters
generally supported the concept of a generic RTM device code, and
offered a wide variety of possible use cases, where FDA approved
devices already exist for the purpose of monitoring various conditions
that do not meet the current scope of the existing RTM codes. These
included monitoring during episodes of care for various neurological
conditions, and others.
Response: We thank the many commenters who suggested ways we could
consider implementation of a possible future generic device code for
RTM. We note that it remains unclear whether a generic device code
would be administrable as a permanent policy, for many reasons. We
refer readers to last year's discussion of valuations of supplies and
equipment for RTM services (86 FR 39173). Comments received in response
to the CY 2023 PFS proposed rule seem to reinforce that it may be
difficult to establish an appropriate valuation for a single device
code that would reflect the myriad of possible applicable devices.
We note that the valuation of a generic device code would require
some consensus on the mix and balance of costs for these devices, which
would be difficult to develop when there such wide variability in the
devices themselves and in how the devices support delivery of RTM
services. Further, we note that a generic device code would require
covering many more clinical topics than exist under our current
policies. Our current policies allow payment using the RTM codes for
services that support an episode of therapy where the clinical issue
ties to musculoskeletal, or respiratory, or medication adherence/
response.
Commenters noted the varied ways that an individual device is
costed and priced for use on the market. Vendors also make available a
broad array of pricing models that clinical practices could consider in
making technology investments to furnish RPM and RTM services. For
example, vendors may offer discounts, or waivers of licensing fees, or
reduced fees for licensing of a device when used with other, unrelated
products; all of these influence the cost of a given device.
We reiterate our clarification included in previous rulemaking (85
FR 84545) that even when multiple medical devices are provided to a
patient, the services associated with all the medical devices can be
billed by only one practitioner, only once per patient, per 30-day
period, and only when at least 16 days of data have been collected; and
[[Page 69648]]
that the services must be reasonable and necessary.
We continue to weigh the possible tradeoffs that would be necessary
to further reduce coding and billing complexity for RTM, and increase
care delivery flexibility and retain appropriate beneficiary access to
RTM services. As noted in the CPT codebook, at page 843, RTM services,
``...represent the review and monitoring of data related to signs,
symptoms, and functions of a therapeutic response. These data may
represent objective device-generated data or subjective inputs reported
by a patient. These data are reflective of therapeutic responses that
provide a functionally integrative representation of patient status.''
We will look to evidence-based peer-reviewed sources, as well as
clinical practice guidelines, in addition to engaging with interested
parties, to inform any decisions about whether it would be practicable
to establish a generic RTM device code that is potentially agnostic to
the specific body system involved (that is, musculoskeletal,
respiratory) or therapy type (that is, medication therapy response)
that the device monitors, in future rulemaking. However, we note that
the CPT codebook makes clear that RTM services must be ordered by a
physician or other qualified health care professional, and that any
device used must be a medical device as defined by the FDA, and that
CPT codes 98980 and 98981 (RTM treatment management codes) should not
be used for time that can be reported using codes for more specific
monitoring services. (CPT codebook, at page 843). Informed by our
experience with RPM payment policy refinements, and in light of
possible forthcoming changes to CPT coding for both RPM and RTM, it
remains unclear whether generic device codes would undermine or stall
progress toward a wider set of specific codes that would provide less
ambiguity. As such, we appreciate the commenters' views on this topic
and the continuing dialogue on these important issues around coding and
payment policies for RTM services.
Comment: Some commenters suggested that the indirect PE allocations
for the proposed GRTM codes do not adequately consider the costs of the
included use of various computer software, and stated that certain
types of software are incorrectly categorized within the PFS; or that
the concepts related to software, and devices themselves, should not be
addressed as categorical questions specific to RTM. Among these
comments, some also expressed concern about the definition of
``device'' in the RTM codes. One commenter noted that CMS does include
specific software costs as supplies within direct PE for other codes,
and suggested that this should be a basis for both reconsidering our
GRTM proposals and the current RPM valuations. Other commenters
requested more clarity about what specific devices would be appropriate
for purposes of RTM services. Many commenters recommended that we
separately consider Software as a Medical Device (SaMD), use of
artificial intelligence (AI)/machine learning algorithms (ML), and
related topics as part of a standalone RFI which would later inform
updates to specific codes because the influence of these topics have
impacts far beyond the RTM codes alone.
Response: Historically, we have considered most computer software
and associated licensing fees to be indirect costs. We refer readers to
our previous discussions of this topic in our CY 2019 final rule. (83
FR 59577). Further, we continue to believe that licensing fees that
would not be allocated to the use of a specific piece of software/
equipment/device for an individual patient for an individual service,
are better understood as forms of indirect costs similar to office rent
or administrative expenses. Refer to our discussion of this aspect of
licensing specifically in our CY 2019 proposed rule (83 FR 35771). As
we noted in section II.B. of this final rule (the RFI for Updates to PE
Methodology section), interested parties have routinely expressed
concerns with allocations of indirect costs, especially for evolving
technologies that rely primarily on software and licensing fees with
minimal costs in equipment or hardware. We continue to engage in
discussions and conduct further research into these topics of AI, SaMD,
and other related evolving technologies, to understand ways that we may
refine our allocations of cost for software and licensing.
We remind readers that in finalizing valuations for the current
family of RTM codes, we have considered the RUC-recommended inputs for
the codes, and in doing so, considered all elements of RTM described by
the AMA in CPT code descriptors. For more detail on this discussion,
refer to last year's proposed rule (86 FR 39173). Within the RTM family
of codes, the structure of the code set relies on use of device codes
(PE only) that are used in conjunction with the remainder of the RTM
codes. CPT code 98976 and 98977 are intended to report a 30-day device
supply with scheduled recordings or program alert transmission to
monitor the respiratory system (98976) or musculoskeletal system
(98977). In the CY 2022 PFS final rule, we finalized refinements to
payment for the three PE-only RTM codes: CPT code 98975 (Remote
therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, therapy adherence, therapy response);
initial set-up and patient education on use of equipment); CPT code
98976 (Remote therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, therapy adherence, therapy response);
device(s) supply with scheduled (e.g., daily) recording(s) and/or
programmed alert(s) transmission to monitor respiratory system, each 30
days); and CPT code 98977 (Remote therapeutic monitoring (e.g.,
respiratory system status, musculoskeletal system status, therapy
adherence, therapy response); device(s) supply with scheduled (e.g.,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days).
We refer readers to the publicly available FDA guidance and
explanations for medical devices, including explanations of SaMD. As
SaMD, as a broader topic, is outside the scope of our proposed
policies, we are not issuing any specific guidance. FDA guidance on
SaMD is available at https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd. Additionally, we
refer readers to CPT Appendix S: AI taxonomy for medical services &
procedures (available at https://www.ama-assn.org/practice-management/cpt/cpt-appendix-s-ai-taxonomy-medical-services-procedures). We note
that our proposals do not include a specific RTM device list, nor
specific examples of RTM devices that would be appropriate for use when
furnishing RTM services. We believe that a possible unintended
consequence of express reference to a device, or list of devices, may
include a preference or shift toward use of one device or class of
device simply because of its inclusion on a list. We believe that the
pace of innovation and evidence-based clinical decision-making inherent
to use of the devices that support furnishing RTM services calls for
medical and behavioral health professionals, groups of behavioral
health and medical professionals, or professional societies, each to
study carefully the needs of the populations under their care, and
identify guidelines that shape selection and use of any specific device
in clinical practice.
Comment: A number of commenters expressed concerns with the
duration of data collection required to meet
[[Page 69649]]
reporting minimums for these codes. Various commenters gave examples of
monitoring requirements for individual clinical needs that would not
require a full 16 days of data. Examples provided addressed use of
standardized screening tools, such as electronically-reported Patient-
Reported Outcomes (e-PRO) tools, which may be collected through SaMD. A
beneficiary using these tools self-reports clinically relevant
information by responding to prompts, based on recall over shorter
periods of time (for example, over the past day, or 7 days). Other
commenters explained that it was ambiguous whether the act of data
collection must occur at least 16 days per month, or if data collection
less than 16 times in a 30-day period would satisfy the requirement
when these data are representative of 16 or more days of clinically
relevant transmittable information.
Some commenters suggested that our proposals would create
unintended consequences of overtreatment to satisfy data collection
minimums, when therapeutic benefit would otherwise be possible in far
fewer therapy sessions or discrete uses of the RTM device. Other
commenters explained that facilitating patient self-management through
tracking adherence, and symptom and trigger logging via a mobile app
all represent collection of data that would be useful to provide
practitioners better insight into clinically meaningful events;
commenters provided examples, such as the use of a remote therapy
monitoring device that connects a patient to an as-needed means to
track potential side-effects of an ongoing, current medication therapy
regimen. In these examples, commenters stated that when a frequency of
use requirement is set in place by the practitioner to satisfy billing
requirements, the requirement represents unnecessary burden for the
beneficiary and may degrade the validity of patient-reported data.
Response: We thank commenters for the feedback on our minimum data
requirements for reporting RTM. Readers should also refer to our
discussion of these requirements in previous rulemaking. (85 FR 84544).
We believe a restatement of our current policies, which points to
existing resources that are publicly available, and were available to
the public when we finalized our existing RTM requirements, would
assist readers in easier access to resources that may inform individual
clinical and beneficiary choices. To avoid possible interference with
clinical decision-making and shared decision-making, at this time, as
discussed in the response immediately above, we are not issuing
specific examples of devices that might be used in the delivery of RTM
services because we believe that to do so could generate further
confusion, as well as have the possible unintended consequence of
implying our approval or endorsement of a specific tool, device, use of
a device, or shift by practitioners toward use of a specific device
when offering RTM services. However, we would be supportive of the
clinical community offering such examples in the context of clinical
practice guidelines, preferably generated with a patient-centered focus
and an emphasis on health equity considerations.
For more background on our earlier development of payment policies
for the related RPM family of codes, refer to the discussion in the CY
2019 FR (83 FR 53015). We believe that as with RPM policy development,
this year's finalized policies may not mitigate the need for further
revisions to coding and payment policies for RTM services, which would
be addressed in future rulemaking, in order to account for some of the
concerns raised by commenters regarding the broad nature of codes that
describe professional collection and interpretation of stored patient
data. Further, also similar to the trajectory of the RPM policies we
developed and refined over the last 5 years, we continue our efforts to
understand better how CPT code revisions that are expected soon, or
planned for future years, would possibly address certain concerns, and
in the specific case of minimum reporting specifications, the CPT
Editorial Committee's consideration of new codes that would require
less than 16 days of data collection.
After considering all of the public comments received on our RTM
proposals this year, we are not finalizing the proposed creation of 4
new G-codes, (GRTM-1-4). Instead, for CY 2023, we are maintaining our
current policies for the RTM treatment management CPT codes 98980 and
98981, with exceptions as noted below. Commenters expressed many
perspectives, views, and general support for remote therapeutic
monitoring services. Yet, the totality of the circumstances and broad
range of interests and priorities presented by commenters leads us to
believe that there should be continued discussion on these topics
before CMS finalizes changes to the current RTM coding and payment
policies that go beyond refinements to our supervision and
documentation requirements for RTM. We continue to engage with the
public, and assess the landscape of RTM devices and services, and will
consider addressing the RTM codes and associated payment policies in
future rulemaking that will aim to build on progress in this area,
while mitigating commenters' concerns.
We are not finalizing our proposal to create 4 new G-codes, (GRTM-
1-4) which we proposed to address various issues relating to incident-
to services, inclusions of clinical staff time, and supervision levels.
CMS proposed to establish a general level of supervision for the two G
codes (GRTM-1 and GRTM-2) that include services incident-to services of
physicians and NPPS, but not for the other G codes (GRTM-3 and GRTM-4).
Commenters recommended that CMS instead permit general supervision of
incident-to services described by the two treatment management CPT
codes (98980, and 98981). With that said, in this final rule, we are
issuing a clarification and finalizing a new policy regarding the
billing requirements for the current RTM codes: CPT codes 98975, 98976,
98977, 98980, and 98981. Beginning January 1, 2023, below modifications
to our existing RTM policies take effect:
General supervision for all RTM services. Any RTM service
may be furnished under our general supervision requirements.
Cognitive behavioral therapy monitoring device. We are
finalizing our proposal to accept the RUC recommendation to contractor
price CPT code 989X6, a PE-only device code. There is no professional
work associated with the code. We will work with our Medicare
Administrative Contractors (MACs) to better understand the kinds of
devices and device costs they are encountering as they review claims
for payment for the new cognitive behavioral monitoring code, CPT code
989X6.
Therapy KX Modifier Threshold Amounts
The KX modifier thresholds, formerly referred to as therapy caps,
were established through section 50202 of the Bipartisan Budget Act
(BBA) of 2018. These per-beneficiary amounts under section 1833(g) of
the Act (as amended by section 4541 of the Balanced Budget Act of 1997)
(Pub. L. 105-33, August 5, 1997) are updated each year based on the
Medicare Economic Index (MEI). Specifically, these amounts are
calculated by updating the previous year's amount by the MEI for the
upcoming calendar year and rounding to the nearest $10.00.
For CY 2023, we proposed to rebase and revise the MEI to a 2017-
base year as discussed in section II.M. of this final rule, and we are
finalizing the 2017-
[[Page 69650]]
based MEI for CY 2023, with technical modifications based on public
comments. Therefore, we are increasing the CY 2022 KX modifier
threshold amount of $2,150 by the CY 2023 MEI of 3.8 percent and
rounding to the nearest $10.00, which results in a CY 2023 KX threshold
amount of $2,230 for PT and SLP services combined and $2,230 for OT
services.
Section 1833(g)(7)(B) of the Act was also added by section 50202 of
the BBA of 2018 and it retains the targeted medical review process, but
at a lower threshold amount of $3,000 (until CY 2028 when it is updated
by the MEI). Accordingly, for CY 2023, the MR threshold is $3,000 for
PT and SLP services combined and $3,000 for OT services. Under the
established targeted review process, some, but not all, claims
exceeding the MR threshold amount are subject to review. Information on
the targeted manual medical review process is available at https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFSCompliancePrograms/Medical-Review/TherapyCap.html.
We track each beneficiary's incurred expenses for therapy services
annually and count them towards the KX modifier and MR thresholds by
applying the PFS rate for each service less any applicable MPPR amount
for services of CMS-designated ``always therapy'' services.
We apply the same PFS-rate accrual process noted above to
outpatient therapy services furnished by critical access hospitals
(CAHs), even though they are not paid for their therapy services under
the PFS and may be paid on a cost basis (effective January 1, 2014).
When the expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. By using the KX
modifier, the therapist and therapy provider attest that the services
above the KX modifier thresholds are reasonable and necessary and that
documentation of the medical necessity for the services is in the
beneficiary's medical record. Claims for outpatient therapy services
exceeding the KX modifier thresholds without the KX modifier included
are denied.
J. Payment for Skin Substitutes
1. Background
In the CY 2022 PFS final rule, in order to address the need to
establish a payment mechanism for synthetic skin substitutes in the
physician office setting and to be responsive to feedback received from
commenters, we finalized an approach for payment of each of 10
synthetic skin substitutes in the physician office setting for which we
had received a HCPCS Level II coding application, and we finalized that
those products would be payable in the physician office setting as
contractor priced products that are billed separately from the
procedure to apply them. The ten products are as follows:
NovoSorb[supreg] SynPathTM, Restrata[supreg] Wound Matrix,
SymphonyTM, InnovaMatrixTM AC, Mirragen[supreg]
Advanced Wound Matrix, bio-ConneKt[supreg] Wound Matrix,
TheraGenesis[supreg], XCelliStem[supreg], Microlyte[supreg] Matrix, and
Apis[supreg] (86 FR 65121). After the CY 2022 PFS Final rule was
released, we deleted the ``A'' code that was established for bio-
ConneKt Wound Matrix after subsequent determination that a HCPCS Level
II code, Q4161, was already established for this product. We note that
since we issued the CY 2022 PFS final rule, we have received additional
HCPCS Level II coding applications for similarly situated 510(k)
cleared wound care management products. HCPCS ``A'' codes have been
issued that described those products and are payable in the physician
office setting as contractor priced products that are billed separately
from the procedure to apply them.
We also received several comments in response to our finalized
policies expressing concern about potential inconsistencies in our
policies for synthetic and non-synthetic skin substitutes. We indicated
we would take these concerns into future consideration.
2. Key Objectives/Roadmap for Consistent Treatment of Skin Substitutes
We outlined our HCPCS Level II coding and payment policy objectives
in section III.N. of the CY 2023 PFS proposed rule (87 FR 46249)
because we believed it would be beneficial for interested parties to
understand our priorities as we work to create a consistent approach
for the suite of products we have referred to as skin substitutes. As
discussed in the CY 2023 PFS proposed rule, we have a number of
objectives related to refining our Medicare policies in this area,
including: (1) ensuring a consistent payment approach for skin
substitute products across the physician office and hospital outpatient
department setting; (2) ensuring that appropriate HCPCS codes describe
skin substitute products; (3) using a uniform benefit category across
products within the physician office setting, regardless of whether the
product is synthetic or comprised of human or animal based material, so
we can incorporate payment methodologies that are more consistent; and
(4) maintaining clarity for interested parties on CMS skin substitutes
policies and procedures. Interested parties have asked CMS to address
what they have described as inconsistencies in our payment and coding
policies, indicating that treating clinically similar products (for
example, animal-based and synthetic skin products) differently for
purposes of payment is confusing and problematic for healthcare
providers and patients. These concerns exist specifically within the
physician office setting; however, interested parties have also
indicated that further alignment of our policies across the physician
office and hospital outpatient department settings would reduce
confusion.
In past years, interested parties have suggested that all skin
substitutes, regardless of the inclusion of human, animal, or synthetic
material in the product, should be treated as drugs and biological
products. Furthermore, they believe all skin substitute products should
receive product-specific ``Q'' codes and receive separate payment under
the ASP+6 methodology. They have expressed confusion regarding our
assignment of HCPCS Level II ``A'' codes to 9 \111\ skin substitute
products referenced in the CY 2022 PFS final rule, which are codes we
typically assign to identify ambulance services and medical supplies,
instead of ``Q'' codes, which we typically assign to identify drugs and
biologicals. They have indicated that the use of HCPCS Level II ``A''
codes has caused confusion, not only for interested parties, but also
for the A/B MACs. The interested parties assert that the A/B MACs have
inconsistently processed submitted claims in part because the products
are assigned HCPCS ``A'' codes are treated as supplies and are subject
to contractor pricing under the PFS. Additionally, interested parties
have expressed concern that physicians and practitioners are hesitant
to use the products associated with ``A'' codes because they are unsure
what they will be paid when using those products. When considering
potential changes to policies involving skin substitutes, we noted that
we believe it would be appropriate to take a phased approach over the
next 1 to 5 years that allows CMS sufficient time to consider input
[[Page 69651]]
from interested parties on coding and policy changes, primarily through
our rulemaking process, with the goal of ensuring access to medically
necessary care involving the use of these products.
---------------------------------------------------------------------------
\111\ As explained above, we deleted the A code for one product
after determining that it had already been assigned a Q code.
---------------------------------------------------------------------------
We welcomed comment on our policy objectives for creating a
consistent approach for treatment of the suite of products we have
referred to as skin substitutes. Additionally, we welcomed feedback on
the phased approach and associated timeline. To achieve our objective
of creating a consistent approach for paying for skin substitutes
across the physician office and hospital outpatient department setting,
we included similar proposed changes in the CY 2023 OPPS proposed rule.
Comment: A few commenters stated that they appreciate CMS' efforts
to improve and clarify policies and procedures and expressed support
for the key objectives and roadmap outlined by CMS for the consistent
treatment of skin substitutes.
Response: We appreciate the commenters' support of our key
objectives and roadmap.
Comment: One commenter suggested that CMS should also consider a
fifth objective to guide decision making with regards to skin
substitutes. Specifically, the commenter suggested that CMS should aim
to provide broad access to these products by Medicare beneficiaries who
would benefit from their use, regardless of wound size, wound type, or
geographic location.
Response: We appreciate this feedback from the commenter and note
that we are interested in health equity for all Medicare beneficiaries.
We will consider potential additional objectives in future rulemaking.
3. Changing the Terminology of Skin Substitutes
In the CY 2023 PFS proposed rule (87 FR 46028), we stated that as
we work to clarify our policies for these products, we believe that the
existing terminology of ``skin substitutes'' is an overly broad
misnomer. In the CY 2021 OPPS/ASC final rule with comment period, we
revised our description of skin substitutes to refer to a category of
biological and synthetic products that are most commonly used in
outpatient settings for the treatment of diabetic foot ulcers and
venous leg ulcers (85 FR 86605). We noted that skin substitute products
are not a substitute for a skin graft as they do not actually function
like human skin that is grafted onto a wound. We also clarified that
our definition of skin substitutes does not include bandages or
standard dressings, and that within the hospital outpatient department,
these items cannot be assigned to either the high cost or low-cost skin
substitute groups or be reported with either CPT codes 15271 through
15278 or HCPCS codes C5271 through C5278. (85 FR 86066).
While this description has been updated to provide clarity that
synthetic products typically regulated as devices by the FDA are
considered to be skin substitutes, there is still confusion with the
usage of the term skin substitutes because as noted in the discussion
above, these skin substitute products are technically not a substitute
for skin, but rather, a wound covering. We have used the current term
``skin substitutes'' to describe the suite of products that are
currently referred to as skin substitutes. Additionally, the term
``skin substitutes'' is used within the Current Procedural Terminology
(CPT[supreg]) code series 15271-8 as maintained by the American Medical
Association. Also, skin substitute products are generally regulated by
the FDA as medical devices under section 510(k) of the Federal Food,
Drug and Cosmetic (FD&C) Act and implementing regulations per 21 CFR
part 807, or as HCT/Ps solely under section 361 of the PHS Act and the
FDA regulations in 21 CFR part 1271. The FDA approves new drugs through
the New Drug Application (NDA) pathway, and approves biological
products through the Biologics License Application (BLA) pathway.
We believe that improving how we reference these products by using
a more accurate and meaningful term will help address confusion among
interested parties about how we describe these products, and further,
how we pay for them. We proposed to replace the term ``skin
substitutes'' with the term ``wound care management'' or ``wound care
management products.'' We explained that we believe this new term more
accurately describes the suite of products that are currently referred
to as skin substitutes while providing enough specificity to not
include bandages or standard dressings, which as noted above, are not
considered skin substitutes. We noted that we understand that the
proposed terms contain the words ``care management'' which could be
construed to implicate the care management series of AMA CPT codes (for
example, 99424-99427, 99437, 99439, 99487, 99489, 99490-99491) that are
commonly used by healthcare professionals. We also explained that we
understand that the use of the word ``management'' in the proposed
terms might be construed by some to implicate AMA CPT Evaluation or
Assessment and Management (E/M) codes. We clarified that the proposed
terms, ``wound care management'' and ``wound care management
products,'' would not implicate the care management series of AMA CPT
codes (for example, 99424-99427, 99437, 99439, 99487, 99489, 99490-
99491), or our own G-codes that describe care management services. Nor
would our proposed terms relate to the AMA CPT E/M codes. Unlike ``care
management'' or ``evaluation and management'' codes and services, the
proposed terms would describe a category of items or products, not a
type of services. Lastly, we noted that we also considered alternate
terms such as wound coverings, wound dressings, wound care products,
skin coverings and cellular and/or tissue-based products for skin
wounds but believe the proposed terms are more technically accurate and
descriptive for how these products are used than the alternatives
considered.
We solicited comment on the proposal to change the terminology we
use for the suite of products referred to as ``skin substitutes'' to
instead use the term ``wound care management'' or ``wound care
management products,'' and on the alternative terms we considered
including wound coverings, wound dressings, wound care products, skin
coverings and cellular and/or tissue-based products for skin wounds. We
noted that we were particularly interested in how these products are
referenced in current CPT coding and would appreciate feedback from the
CPT Editorial Panel and other interested parties on how to address the
challenges we discuss above. We also requested comment on other
possible terms that could be used to more meaningfully and accurately
describe the suite of products currently referred to as skin
substitutes.
Comment: A few commenters agreed with the proposed terminology
change to wound care management products.
Response: We thank the commenters for their feedback and support.
Comment: Several commenters disagreed with the proposed terminology
change, as well as with all of the alternative terms we considered; and
suggested that we should retain the term skin substitute. Some
commenters stated that the CPT Editorial Panel was purposeful in
creation of the skin substitutes application codes (CPT codes 15271-
15278) to specifically describe instances that are, and are not,
appropriate to report as the application of skin substitutes. In
contrast, the CPT procedure codes associated with wound care management
are distinctly different in both purpose and products used in their
delivery. A few commenters stated that it is clear that skin
substitutes are very specific and separately reportable from wound
dressings, and changing the
[[Page 69652]]
terminology to wound management would differ from CPT nomenclature and
cause confusion and inconsistent reporting. A few commenters stated
that changing the terminology to wound care management products would
conflate skin substitute products with other products like wound care
dressings or bandages. The commenters stated that the proposed
terminology incorrectly suggests that the skin substitute products are
not technically a substitute for skin, but rather, a wound covering
that is used to promote healing. The commenters stated that this is not
accurate, as the application of skin substitutes serves a specific
purpose of temporary or permanent coverage of open skin wounds.
Therefore, the commenters stated that the assumption that a skin
substitute is just a wound covering is inaccurate. They stated that the
application of the product is part of the recovery process, and
indicated that the product does function similarly to skin as it is not
always removed. The commenters stated that whether the product is
applied temporarily and later removed, or is placed and not removed,
the skin substitute is allowing for the construction of natural dermis
which goes above and beyond a ``wound covering.'' The commenters
further pointed out that the CPT coding guidelines specifically outline
the application of skin substitutes grafts as non-autologous human skin
grafts, non-human skin substitute grafts, and biological products that
form a sheet scaffolding for skin growth. The commenters asserted that
there is a possibility that as technology evolves, new categories of
wound care may become available; however, the CPT guidelines and
reporting for skin substitutes are clear and they do not include the
application of non-graft wound dressings (for example, powder,
ointment, foam, liquid) or injected skin substitutes, and those items
should not be lumped together in a catch-all terminology such as wound
management. Some commenters stated that the proposed terminology is not
necessarily more accurate or meaningful than the existing term. A few
commenters suggested that CMS work directly with the CPT Editorial
Panel, relevant medical specialty societies, and industry
representatives to determine the optimal approach to updating skin
substitutes terminology.
Response: While we continue to believe that the term skin
substitutes is an overly broad misnomer, and believe that improving how
we reference these products by using a more accurate and meaningful
term will help to address confusion about how we describe these
products, we also believe that it is important to adopt the most
appropriate terminology to more accurately capture the full suite of
products. After considering the public comments, we believe that
additional dialogue will be beneficial before finalizing new
terminology. The feedback received through the public comments process
has been helpful and informative, and we would like to further engage
with stakeholders prior to adopting any new terminology in future
rulemaking. As such, we are not finalizing changes to the terminology
at this time. We will continue to carefully consider the comments that
were received in response to this proposed rule, and welcome additional
input from interested parties. Additionally, we intend to hold a Town
Hall in early 2023, prior to CY 2024 rulemaking, to have additional
discussions in an effort to further understand the concerns interested
parties have about potential new terminology we could consider and any
other alternative terms not yet considered.
Comment: Several commenters agreed that the term skin substitute is
not accurate and stated that it does not reflect the entry of
synthetics in the marketplace, but disagree with the proposed
terminology.
Response: As indicated above, though we still intend to change the
terminology to more accurately capture the full suite of products, we
are not finalizing a change in terminology at this time. We intend to
discuss this issue further in a Town Hall and anticipate addressing it
in future rulemaking.
Comment: A few commenters suggested alternatives including:
Cellular and/or Synthetic Grafts for Surgical Wound Management;
Bioengineered, Cellular or Tissue-Based Products; Skin Matrix/Matrices;
and Ulcer/Wound Care Products. Several commenters supported use of one
of the alternative terms we considered, Cellular and/or tissue-based
products (CTPs) for skin wounds, and stated that it was consistent with
the American Society for Standards and Materials (ASTM) definition of
skin substitutes, and is nomenclature used by wound care clinicians;
one commenter also indicated that CTPs is inclusive of both current and
future technology.
Response: We appreciate the support from commenters for one of the
alternative terms we considered. We intend to have more discussion
about appropriate changes to the terminology for skin substitutes as
indicated above. We expect to hold a Town Hall early next year before
CY 2024 rulemaking to provide an opportunity to further engage
interested parties on this matter and provide a forum for additional
discussion as we seek to identify the most reasonable approach going
forward.
Comment: One commenter stated that changing the terminology to
wound care management products does not align with FDA guidance on
permitted use of HCT/Ps for reconstruction, repair, or replacement
under 21 CFR 1271.3(f)(1), and therefore, HCT/Ps which are a subset of
CTPs should not be considered as equivalent to other wound care
management products and considering HCT/Ps as equivalent to other wound
care management products would create confusion.
Response: We appreciate the feedback from the commenter. As
previously indicated, we are not finalizing changes to the terminology
at this time, and intend to further engage interested parties on this
matter.
Comment: One commenter expressed support for CMS's efforts to more
accurately describe skin substitute products amid an evolving wound
care environment, but disagreed with the proposed name change and
recommended that we continue with the term skin substitute which they
believe accurately reflects this category. The commenter stated that
while skin substitutes are not a term under the FDA, the terminology
has been used for some time in medical vernacular. The commenter stated
that the proposal to change the terminology will in effect diminish the
time, resources, and cost that goes into manufacturing and applying
these products.
Response: We disagree that the term skin substitute is the best
term to reflect this suite of products despite the longstanding use of
the term in the industry. We continue to believe that improving how we
reference these products by using a more accurate and meaningful term
will be beneficial as we work to create a consistent approach for
treatment of these products across settings. As previously indicated,
we are not finalizing changes to the terminology at this time, and
intend to further engage interested parties on this matter.
Comment: One commenter stated that they support the goal of
replacing old terminology, but stated that purely synthetic products
should not be included within the classification. The commenter also
stated that excluding synthetics is consistent with the industry
standards including ASTM which defines CTPs. The commenter recommended
that we exclude all 100
[[Page 69653]]
percent synthetic products. Another commenter stated that CTPs is an
outdated misnomer because the term explicitly excludes synthetic skin
substitutes since it only refers to a subset of skin substitutes (those
comprised of animal or human cells or tissues).
Response: As stated in the proposed rule, one of our key objectives
in creating a consistent coding and payment approach for the suite of
products currently referred to as skin substitutes is to address
concerns regarding differential treatment for clinically similar
products (as an example, animal-based, and synthetic skin products).
Additionally, we note that the Standard Guide for Categories and
Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin
Wounds (ASTM F3163-22) available on ASTM's website (https://www.astm.org/f3163-22.html), states that CTPs may include synthetic
components.
Comment: A commenter stated that changing the terminology would
create confusion and coding challenges because the AMA has already
published the 2023 CPT Codebook, and applications for changes to the CY
2024 CPT Codebook may no longer be made. Therefore, a change to the
terminology contained in the CPT code set for the codes that describe
product application procedures could not take effect until CY 2025. The
commenter stated that creating a discrepancy between the way CMS refers
to such products and CPT describes the application procedures in the
CPT code set would create burdensome disruptions to providing wound
care services.
Response: We note that as we navigate our roadmap, we anticipate
that there will likely be some transition time, in which the industry
would potentially need to clarify or adopt new terminology more
broadly; however, as previously indicated, we are not finalizing a
change in terminology at this time to allow an opportunity for
additional discussions and input from interested parties.
Comment: One commenter stated that CMS should treat powder skin
substitute products the same as sheet products under the PFS. The
commenter stated that powder skin substitutes are not bandages or
simple wound dressings and that when applied to a wound, powder
products have demonstrated the same ability to form a sheet scaffolding
for wound healing as sheet products.
Response: We did not make any specific proposals regarding the
treatment of powder skin substitute products. Therefore, this comment
is outside the scope of the proposals in the proposed rule. We thank
the commenter for the suggestions.
4. Revising Payment for Skin Substitutes
In 2003, the Medicare Modernization Act established the Average
Sales Price (ASP) approach for drugs and biologicals as described under
section 1847A of the Act. We generally considered skin substitute
products to be biologicals in our initial implementation of the ASP
methodology. However, with the introduction of synthetic skin
substitute products over the last several years, we are reviewing our
categorization of these products, especially as we work to establish
payment policies for these products across the various care settings.
As explained above, we announced in the CY 2022 PFS final rule that we
would establish HCPCS Level II codes for certain products for which we
had received a HCPCS Level II coding application. We also finalized
that these products would be payable in the physician office setting as
contractor priced products that are billed separately from the
procedure to apply them (86 FR 65120). After we issued the CY 2022 PFS
final rule, we assigned nine HCPCS ``A'' codes for the synthetic skin
substitute products that were addressed in the rule.
In the CY 2022 PFS final rule, we stated that we recognized there
was no payment mechanism for synthetic skin substitute products within
the PFS, and we acknowledged the need to reconcile the gap in payment
for synthetic products in the physician office setting without delay
(86 FR 65121). Additionally, as we described in the CY 2022 PFS final
rule, a commenter stated that skin substitutes are a heterogenous group
and there is an increasing intersection between biological,
bioengineered, and synthetic components. This highlights that the
current categorization of skin substitutes as either synthetic or non-
synthetic is not mutually exclusive given the expansion of skin
substitute products that may contain both biological and synthetic
elements. The increasing overlap of both synthetic and non-synthetic
skin substitute products emphasizes the importance of treating all skin
substitute products in a similar manner in terms of coding and payment.
After further review, we agree with interested party
recommendations that the suite of products referred to as skin
substitutes should be treated in a uniform manner across different
outpatient care settings. In terms of payment for these products within
the office setting, we acknowledge the current variation between
contractor pricing for synthetic skin substitute products and payment
based on ASP+6% for non-synthetic skin substitute products; and also,
the challenges to the clear categorization of products as synthetic or
non-synthetic. We believe establishing a consistent framework for how
these products are treated within the physician office and hospital
outpatient settings will help ensure equitable access and appropriate
payment for these services.
In order to ensure we treat skin substitutes consistently in terms
of coverage, coding, and payment, we proposed that skin substitute
products that are commonly furnished in the physician office setting be
considered as incident-to supplies in accordance with section
1861(s)(2)(A) of the Act, effective January 1, 2024. ``Incident-to
supplies'' refers to supplies that are furnished as an integral,
although incidental, part of the physician's personal professional
services in the course of diagnosis or treatment of an injury or
illness (Sec. 410.26). As proposed, in the office setting, we would no
longer pay separately for skin substitute products under the ASP+6%
payment methodology.
We proposed that as we are categorizing skin substitute products
that are furnished in the office setting as incident-to supplies, we
would consider the cost of the supply used in furnishing a physicians'
service through the PFS practice expense (PE) methodology. Treating
these products as incident-to supplies would mean that the resource
costs for these products would be included in establishing PE relative
value units (RVUs) for the associated physicians' service with which
they would be furnished. For example, for CPT Code 15271 (application
of skin substitute graft, leg or ankle), we establish the PE RVU by
considering three separate categories of PE resource costs involved in
furnishing the service: clinical labor, supplies, and equipment.
Together, these costs are the total direct PE resource inputs. When
considering these skin substitute products as a supply, we would add
their associated cost to the direct PE inputs for the service with
which the product is furnished. For a more detailed description of the
PE RVU methodology, please refer to section II.B. of this final rule,
Determination of Practice Expense Relative Value Units in the rule.
We acknowledged that the proposed change to consider skin
substitute products furnished in the office setting as incident-to
supplies would not be implemented immediately in CY 2023. Rather, we
explained that we would need to transition toward consistent
[[Page 69654]]
coding and payment for these products. We referred readers to section
III.N. of the proposed rule for the proposed changes to our process for
assigning HCPCS Level II codes to wound care management products.
We discussed that we believe it is necessary to establish an
effective date of January 1, 2024, for the proposed payment of skin
substitutes in the non-facility setting as incident-to supplies in
order to align with the HCPCS Level II coding proposals for wound care
management products as described in section III.N. of the proposed
rule, to ensure all interested parties have the same opportunity to
effectively transition toward the coding and payment changes.
Additionally, we noted that we intend to engage with interested parties
via an open-door forum/listening session to receive additional
feedback.
To summarize, we proposed to treat skin substitutes (including
synthetic skin substitutes) as incident-to supplies as described under
section 1861(s)(2)(A) of the Act when furnished in non-facility
settings and to include the costs of these products as resource inputs
in establishing practice expense RVUs for associated physician's
services effective January 1, 2024. The proposal would mean skin
substitutes are treated in the same manner for purposes of payment when
furnished in non-facility settings, and would be consistently
contractor priced through CY 2024. Given these changes, we believe
maintaining the current treatment of these products for purposes of
payment during CY 2023 will ensure a smooth transition. We also
proposed to discontinue the use of the term skin substitutes beginning
January 1, 2024 and to instead refer to this suite of products as
``wound care management products.'' We solicited feedback on the
proposals.
The following is a summary of the public comments received on the
proposed revisions to the Payment for Skin Substitutes and our
responses:
Comment: Many commenters stated that the proposal to revise payment
for skin substitutes does not provide enough information about how
these skin substitute products will be packaged and paid for if
finalized in the CY 2023 final rule to be effective for CY 2024. More
specifically, several commenters requested clarification on cost
information used to establish contractor pricing for skin substitute
products, how skin substitute products will be incorporated in the PE
RVU methodology, and the dollar amount that would be included in the
bundle for these skin substitute products. Additionally, these
commenters mentioned that our proposal lacks sufficient time for
interested parties to effectively transition products that were
previously assigned Q codes to shift to A codes in order to meet the
proposed changes to incident-to supply effective CY 2024. As a result,
these commenters stated that they could not provide meaningful comment
on these significant policy changes and urged CMS to delay the
implementation of this proposal until these necessary details are
addressed.
Response: We appreciate all of the public comments on the proposal,
especially questions and comments received regarding how we intend to
achieve our policy goals. To clarify several significant questions, for
CY 2023, CMS did not propose to make any changes to the existing
payment methodology under the PFS associated with the proposed change
to pay for skin substitute products as incident-to supplies. Rather,
our proposal was to pay for these products beginning for CY 2024 as
incident-to supplies in the same way that we pay for other incident-to
supplies.
Based on our review of the comments received, we understand that it
would be beneficial to provide interested parties more opportunity to
comment on the specific details of changes in coding and payment
mechanisms prior to finalizing a specific date when the transition to
more appropriate and consistent payment and coding for these products
will be completed. While we continue to believe that the current,
transitory situation where like products are not being paid and treated
consistently is unsatisfactory, unsustainable over the long term, and
rooted in historical practice established two decades ago prior to
significant evolutions in medical technology and practice, we believe
additional opportunity for information sharing and subsequent
rulemaking is necessary before the transitory policies can be retired.
In consideration of the comments and in the interest of ensuring
appropriate payment and access in accordance with our above outlined
policy objectives for creating a consistent payment approach across
payment systems, benefit categories, and coding for treatment of the
suite of products we have referred to as skin substitutes, we are going
to conduct a Town Hall in early CY 2023 that will be open to interested
parties in order to provide additional opportunity for discussion to
address these concerns as well as discuss potential approaches to the
methodology for payment of skin substitute products under the PFS. We
will take into account the comments we received in response to CY 2023
rulemaking and feedback from the Town Hall in order to strengthen
proposed policies for skin substitutes in future rulemaking.
Comment: Some commenters stated that the proposal to revise payment
for skin substitute products under the PFS is concerning because the
proposal did not include an impact analysis.
Response: Since the proposal to categorize skin substitute products
as incident to supplies does not take effect until CY 2024, any
corresponding impact analysis would be included as part of rulemaking
for CY 2024. However, as stated above, we recognize the need to ensure
more opportunity for information sharing, notice, and comment
rulemaking prior to completing the transition to equitable payment for
like products. As a result, we will further discuss approaches towards
a consistent payment mechanism for skin substitute products at the Town
Hall with interested parties.
Comment: Many commenters disagreed with bundling the payment of
skin substitute products into the payment for the procedures that use
the products under the PFS. These commenters raised the concern that
packaging payment of skin substitute products in non-facility settings
will cut payment for the products and pose financial burden to
providers, which would limit or eliminate the options of skin
substitute products offered to patients. Commenters also stated that
cutting payment rates for skin substitutes would stifle innovation for
these products that are necessary to effectively treat a vulnerable
patient population. Additionally, some commenters stated that if CMS
were to bundle skin substitute products similar to the bundling of
policies under the OPPS for services furnished in the hospital
outpatient department, then large wounds would not be treated any
longer in the physician office setting due to the excessive cost and
low payment for the supplies, thus, redirecting these patients toward
more costly inpatient hospital settings. Furthermore, commenters stated
that the PE RVU methodology referenced in the proposed rule should not
be used as a payment methodology for skin substitute products since
these products are expensive, and absorbing them into the PE would
cause a decrease in PE payment for other areas due to the PE RVU's
budget neutrality requirements.
Response: We thank commenters for their feedback and concerns
regarding bundling payment and using the PE RVU methodology for skin
substitute products under the PFS. In response to
[[Page 69655]]
these and other similar comments, and as previously stated, we are not
finalizing the proposed payment methodology for skin substitute
products under the PFS.
Comment: Many commenters disagree with the proposal to recategorize
all skin substitute products as incident-to supplies. Commenters stated
that biological skin substitute products should be a category of its
own due to the complexity of biological skin substitutes and the
certain preparation and procedural codes that are required for
biological skin substitutes. Thus, commenters stated that they believe
that grouping the biological and synthetic skin substitute products
together disregards how these products are treated clinically.
Commenters also stated that skin substitutes are incorporated into the
wound bed to aid healing and have certain regulatory requirements
unique to skin substitutes. Due to these issues, commenters emphasized
that skin substitutes are vastly different from other supplies such as
wound dressings/bandages, which fall within the incident-to supply
category. Furthermore, these commenters reiterated similar concerns to
other commenters about bundling payment for skin substitutes with
payment for the procedures in which they are used, which would also
accompany recategorizing these products as incident-to supply.
Response: As mentioned previously, we plan to hold additional
discussions with interested parties during a Town Hall session to
discuss potential alternative approaches for equitable payment and
treatment of skin substitute products in the physician office setting.
This will ensure ongoing dialogue to address concerns around bundling
payment (which is typically the approach for incident-to supplies) for
all skin substitute products.
Additionally, we noted in the proposed rule that skin substitute
products are not a substitute for a skin graft as they do not actually
function like human skin that is grafted onto a wound. We also
clarified that our definition of skin substitutes does not include
bandages or standard dressings (87 FR 46028). As highlighted in the
proposed rule, skin substitutes are a heterogenous group and there is
an increasing intersection between biological, bioengineered, and
synthetic components. This highlights that the current categorization
of skin substitutes as either synthetic or non-synthetic is not
mutually exclusive given the expansion of skin substitute products that
may contain both biological and synthetic elements (87 FR 46028).
Therefore, prompting us to recognize the need to achieve a standardized
approach to pay for these products.
Comment: Some commenters presented a few concerns that our proposal
to treat all skin substitute products as incident-to supplies is
contrary to current statute. Specifically, these commenters were
concerned that categorizing skin substitute products as incident-to
supplies in the physician office setting would be inconsistent with the
applicable payment framework for biologicals provided in a physician
clinic, as set out in sections 1842 and 1847A in the Act. Another
commenter also stated that the products approved through a drug or
biological pathway like a BLA or NDA are vastly different compared to
products approved as 510(k) devices or regulated as HCT/Ps; therefore,
the commenter believes NDA/BLA skin substitute products should remain
separate and paid as a drug/biological. Lastly, one commenter stated
that the lack of any impact analysis or evidence that supports our
proposal is contrary to Administrative Law.
Response: As mentioned previously, we recognize the importance of
information sharing and notice, which we look forward to addressing
with interested parties at the Town Hall.
Comment: Several commenters suggested various alternative payment
approaches. For example, one commenter suggested that CMS should
separately identify and pay for high-cost disposable supplies priced
more than $500 using appropriate HCPCS codes, where the pricing would
be based on a transparent and annual review process under the PFS.
Another commenter suggested that we create five unique A-codes that
would cover all skin substitutes based on composition-based categories.
Then, the skin substitute approved products would be paid separately at
the same rate per square centimeter in order to ensure there are no
gaps in care for large wounds.
Response: We thank commenters for their feedback and look forward
to ongoing discussions regarding alternative payment approaches for
skin substitutes.
Comment: Several commenters expressed concern about what they
viewed as a payment disadvantage for synthetic skin substitute
products, if biological skin substitute products are paid using the
ASP+6% payment methodology, whereas synthetic skin substitute products
are contractor priced under the PFS. Overall, these commenters
supported our proposal to treat all skin substitute products as
incident-to supplies, since it ensures consistency for all skin
substitute products in terms of payment, across multiple settings.
Response: We thank the commenters for their support. As noted in
the CY 2023 PFS Proposed Rule, we acknowledged the current variation
between contractor pricing for synthetic skin substitutes and payment
based on ASP+6% for biological skin substitute products. As a result,
we believe achieving a consistent payment mechanism is important and
look forward to discussing ways in which to achieve this with
interested parties at the Town Hall.
Comment: A few commenters stated that they support a multi-year
phased approach consistent with the five-year timeline to improve
clarity and consistency of payment policies for skin substitutes, but
expressed confusion regarding the longer-term road map given the stated
implementation date of CY 2024.
Response: We appreciate the commenters' support for our phased
approach, and clarify that we anticipate addressing various
considerations over the next few years through rulemaking. As indicated
above, we are delaying changes to the terminology to allow for
additional discussions with, and input from interested parties.
Additionally, we will consider payment approaches in future rulemaking.
After consideration of the public comments, we are not finalizing
our proposal to change the terminology for skin substitutes at this
time, and intend to further engage interested parties and allow an
additional opportunity for input regarding the most appropriate term
that could be used to more meaningfully and accurately describe the
suite of products currently referred to as skin substitutes. We intend
to revisit the change in terminology in future rulemaking as early as
next year. Further, after considering the issues raised in public
comments, we are not finalizing the payment approach outlined in the
proposed rule where we considered establishing payment under our
typical approach for incident- to supplies using our PE RVU
methodology. Instead, we intend to conduct a Town Hall with interested
parties in early CY 2023 to discuss alternative potential payment
approaches for skin substitute products prior to CY 2024 rulemaking in
order to achieve a transition to equitable payment for like products;
we will also use this Town Hall as an opportunity to discuss the
aforementioned change to the terminology.
[[Page 69656]]
K. Provision To Allow Audiologists To Furnish Certain Diagnostic Tests
Without a Physician Order
Audiologists are recognized under Medicare Part B to provide
certain diagnostic audiology services as defined at section 1861(ll)(3)
of the Act. Specifically, the statute describes audiology services that
include such hearing and balance assessment services as the audiologist
is legally authorized to perform under State law, as would otherwise be
covered if the services were furnished by a physician. The definition
of qualified audiologist appears at section 1861(ll)(4)(B) of the Act.
Currently, the only other provision in the Medicare statute that
relates to audiology services is found at section 1862(a)(7) of the
Act, which excludes payment for hearing aids and related examinations.
This exclusion is codified at Sec. 411.15(d)(1), which precludes
payment for hearing aids or examinations for the purpose of
prescription, fitting, and changing hearing aids. There are no other
Medicare statutory provisions addressing audiologists or audiology
services. Diagnostic tests are included as a Medicare Part B benefit
under section 1861(s)(3) of the Act.
For many diagnostic testing services, payment under the PFS can be
made in two separate components of the service when parts of the
services are furnished by two different physicians, practitioners, or
other suppliers: the technical component (TC) and the professional
component (PC). The TC is the portion of the service that involves the
collection of information from the patient--for example, a sample,
specimen, radiological image, or interrogatory study. When the TC is
furnished separately, the ``TC'' modifier is used with the relevant
HCPCS code to bill for the service under the PFS. The PC of a
diagnostic test is the portion of the service involving the
interpretation of the collected information by a physician or other
practitioner. When the PC is furnished separately, the service is coded
with modifier ``26''. When the same physician or practitioner furnishes
both the TC and PC of the service, the relevant HCPCS code (known as
the ``global'') is billed without a modifier. We have established
general requirements for furnishing and billing diagnostic tests at
Sec. 410.32.
In the CY 1997 PFS final rule, we established in regulations at
Sec. 410.32(a), based on long-standing manual provisions, that all
diagnostic tests, including audiology tests, must be ordered by the
physician who is treating the beneficiary who will use the results to
manage the beneficiary's care. We believed this requirement was
necessary to ensure that the physician had a relationship with the
beneficiary, and would ensure the tests were reasonable and medically
necessary, as well as prevent patterns of abuse. At the same time, we
finalized a regulatory provision at Sec. 410.32(c) (later redesignated
to Sec. 410.32(a)(2)) to recognize as the treating practitioner for
the purpose of ordering diagnostic tests certain nonphysician
practitioners (NPPs) who are authorized under the statute to provide
services that would be physician services if furnished by a physician
when they are operating within the scope of their State license. The
NPPs who can serve as the treating practitioner for purposes of
ordering diagnostic tests include physician assistants (PAs), nurse
practitioners (NPs), and clinical nurse specialists (CNSs) (defined in
sections 1861(s)(2)(K)(i) and (ii) of the Act, respectively), certified
nurse-midwives (defined in section 1861(gg) of the Act), qualified
psychologists (defined in section 1861(ii) of the Act), and social
workers (defined in section 1861(hh) of the Act)) (61 FR 59497 through
59498). We note that all of these NPPs are included as practitioners
who must accept Medicare payment on an assignment-related basis under
section 1842(b)(18)(C) of the Act. As such, these NPPs can only collect
any applicable cost-sharing from the patient, and cannot balance bill
the patient for additional amounts above the Medicare payment amount.
The regulation reflecting the ordering requirements for diagnostic
tests has not been substantively amended since that time, except to add
an exception to the treating practitioner ordering requirement for
screening mammography and, in response to the PHE for COVID-19, to add
a limited exception for a single, otherwise-covered COVID-19 diagnostic
test (and one otherwise covered diagnostic laboratory test for flu or
similar respiratory condition needed to diagnose COVID-19) per patient
per year during the PHE.
In the CY 1998 final rule (62 FR 59057 through 59070), we also
amended Sec. 410.32(a) to clarify that the ordering requirement is
based on the exclusion in section 1862(a)(1)(A) of the Act and
contained in Sec. 411.15(k)(1); that is, diagnostic testing services
that do not meet the ordering requirements in Sec. 410.32(a) are
considered not reasonable and necessary for the diagnosis and treatment
of illness or injury or to improve the functioning of a malformed body
member. We explained that we found tests not demonstrably reasonable
and medically necessary if they are not ordered by the beneficiary's
treating physician or practitioner who will use the test results to
manage the beneficiary's condition or symptom. Also in the CY 1998 PFS
final rule, while we continued to require physician supervision for
most diagnostic tests, we amended our regulation to except diagnostic
tests personally furnished by audiologists (as well as psychologists
and certain physical therapists board-certified in electrophysiology)
from the physician supervision requirement.
As explained above, all of the NPPs that we recognize as treating
practitioners in Sec. 410.32(a)(2) for purposes of the diagnostic test
order requirement who must accept Medicare payment on an assignment-
related basis can only collect any applicable cost-sharing from the
patient and cannot balance bill the patient for additional amounts.
Audiologists are not NPPs as defined by the statute (that is, they are
not listed at section 1842(b)(18)(C) of the Act). However, beginning in
2008, we allowed audiologists to enroll in the Medicare program so that
they could independently bill for their audiology services rather than
relying on physicians or other enrolled practitioners to bill on their
behalf. As such, audiologists are not required to accept payment on an
assignment-related basis.
Over the past several years, interested parties have requested that
CMS eliminate the treating physician or other practitioner order
requirement for the hearing and balance assessment services furnished
by audiologists. They have suggested that CMS has the administrative
authority to eliminate the order requirement for audiology services via
notice and comment rulemaking, and that doing so would enable greater
access to these important services. The interested parties believe that
an order from the treating physician or practitioner is not required by
the statute, and that audiology services are covered unless they are
otherwise excluded, such as because they are not reasonable and
necessary in a particular circumstance. To support their points, these
interested parties shared with us a report prepared in 2020 by a
consultant concluding that removal of the treating physician or
practitioner ordering requirement for audiology hearing and balance
assessment services would result in an estimated savings to Medicare
over a 10-year period of approximately $108 million, which includes a
savings of $36 million in
[[Page 69657]]
beneficiary copayments. These savings estimates are based on projected
Medicare payments and beneficiary copayments that would not occur if
Medicare beneficiaries directly accessed the audiology hearing and
balance services furnished by an audiologist without the order of a
treating physician or other practitioner. In addition, we have heard
from interested parties that an order is not required for audiology
services by certain other public or private health insurers including
Medicare Advantage plans, Medicaid, plans under the Federal Health
Benefit Program, and the Veterans Administration. We do not know the
scope of services that are covered by these plans or insurers when
furnished by audiologists, including whether these health insurers
cover only hearing and balance assessment services (as the Medicare
program does in accordance with the statute) or also hearing aid
examinations for the prescription, fitting, and programming of hearing
aids or other services excluded from payment under Medicare Part B and/
or whether only some or all of the plans allow payment directly to
audiologists for some or all of the covered services without a
physician/NPP order. Additionally, we note that some of these health
insurance programs involve closed systems with greater levels of
interprofessional communication and control (for example, within
certain accountable care organizations (ACOs), managed care plan
networks, or through various Veterans Affairs medical centers). In
contrast, the physicians and practitioners furnishing care under the
fee-for-service Medicare Part B program often practice independently
from each other, which can pose barriers to communication and
coordination of care between health care professionals such as
audiologists and the treating physicians or other practitioners.
In addition, the nature of audiology services personally furnished
by audiologists is such that these services are often billed based on
the audiologist's reassignment of billing rights by an entity other
than the furnishing audiologist, so we are currently unable to
determine the number of audiologists furnishing these services or the
full scope of beneficiary utilization of these services in those
settings.
While we believe that CMS has the administrative authority to
remove the treating physician or practitioner order requirement for
audiology hearing and balance assessment services via notice and
comment rulemaking, we do not agree with the suggestions of interested
parties that audiologists should be considered in the same way as the
NPPs we recognized as treating practitioners for purposes of the order
requirement under Sec. 410.32(a)(2). Specifically, we allowed the NPPs
(including PAs, NPs, and CNSs) to order diagnostic tests for the
beneficiaries they treat, and we continued to require that the results
of the tests be used in the management of the patient's specific
medical problem. In these cases, the relationship of the patient to the
NPP who orders diagnostic tests and uses the results in managing the
beneficiary's medical condition serves to provide assurance that the
services are medically necessary. In contrast, audiologists are not
recognized under Medicare Part B to treat or manage patients. We
consider audiologists' services to be more specialized than those of
other physicians and NPPs who provide diagnostic services. That is,
their diagnostic tests are more limited and focused in scope than
others furnishing services under the Medicare Part B benefit for
diagnostic tests at section 1861(s)(3) of the Act. Unlike PAs, NPs or
CNSs who may bill for E/M services, and for whom Medicare Part B covers
services and supplies incident to their own professional services as
provided in the regulation at Sec. 410.26, the scope of audiology
services under the Medicare Part B statute includes only diagnostic
hearing and balance assessment services. We are concerned that removal
of the order requirement for hearing and balance services furnished by
audiologists could lead to the furnishing and payment of services that
are not used by a treating physician or practitioner in the management
of the patient's medical condition, and thus, not medically necessary.
We are also concerned about patient safety if Medicare beneficiaries
seek hearing and balance services directly from audiologists without
the involvement of a treating physician or practitioner. For example,
the beneficiary could have an acute condition or symptom such as acute
sensorineural hearing loss resulting from a viral neuronitis that needs
to be diagnosed and treated by a physician or practitioner on an
emergent basis, and that care could be delayed if the beneficiary first
sought care directly from an audiologist. As an additional example,
disequilibrium has many possible causes, including potentially life
threatening cardiologic (for example, arrythmias, heart attack, or
cardiac ischemia) and neurologic etiologies (for example, migraines,
TIAs (transient ischemic attacks), strokes). The wide variety of
possible causes of disequilibrium with some of these in both categories
being potentially life threatening (for example, stroke, heart attack,
arrythmias) speaks to the importance of a physician or NPP being
involved in the initial patient assessment. Such an assessment would
include a careful history, a physical examination, and immediate
office-based testing (for example, EKG) to look for some of the more
critical possible causes of disequilibrium, and the physician or NPP
would determine the plan for the progression of the outpatient workup.
That is to say, the physician or NPP would decide, given the history
and clinical exam, whether the evaluation should continue along
cardiologic, neurologic, or vestibular perspectives--the latter of
which could possibly result in an order/referral to an audiologist for
balance assessments using the vestibular dysfunction testing codes. For
these reasons, we believe patients with disequilibrium would be best
served by seeing a physician or NPP before being referred to an
audiologist as appropriate. Furthermore, as previously noted,
audiologists are not required to accept Medicare payment on an
assignment-related basis, and therefore, can balance bill the
beneficiary. We are concerned that the removal of the treating
physician or practitioner ordering requirement, and potentially
increased volume of audiology services, could lead to unnecessary costs
to beneficiaries. In addition, in the absence of a required order of
the treating physician or practitioner, we are concerned that the
direct access to audiologists might incentivize changes in behavior and
practice patterns among audiologists that could lead to overutilization
of audiology services.
We have carefully considered the interested parties' requests to
remove the treating physician or practitioner order requirement for
diagnostic audiology hearing and balance assessment services. We
believe it would be appropriate to provide a limited exception to the
order requirement for diagnostic hearing testing services furnished by
audiologists in order to broaden patient access to these services. In
response to the requests of interested parties, we proposed to amend
our regulation by adding a paragraph at Sec. 410.32(a)(4) to remove
the order requirement under certain circumstances for certain audiology
services furnished personally by an audiologist for non-acute hearing
conditions. These non-acute hearing conditions would not include
balance assessments that are used for patients with disequilibrium,
because as we
[[Page 69658]]
explained above, the physician/NPP needs to first evaluate the patient
clinically due to the many serious medical conditions the beneficiary
might have, and ensure the patient is cleared medically before setting
them on track to receive vestibular function tests, possibly from an
audiologist. The list of audiology services for which Medicare payment
can be made when an audiologist personally performs them on the order
of the treating physician or NPP can be found on the Medicare physician
fee schedule web page under the link titled ``Audiology Services'' at
https://www.cms.gov/medicare/medicare-Fee-for-Service-Payment/Physicianfeesched. We proposed to permit the services described by the
codes listed in Table 35 to be furnished under the proposed exception
without the order of the treating physician or NPP. We noted that Table
35 does not include the codes for vestibular function tests in the CPT
code ranges of 92517-92519 and 92537-92549 because, as discussed above,
we believe it is in the clinical interest of the beneficiary to be
assessed by a treating physician or NPP for potentially serious medical
implications of disequilibrium symptoms, including cardiologic and
neurologic etiologies before they can be cleared and referred for
vestibular function tests.
BILLING CODE 4150-28-P
[GRAPHIC] [TIFF OMITTED] TR18NO22.065
BILLING CODE 4150-28-C
We proposed to create HCPCS code GAUDX (Audiology service(s)
furnished personally by an audiologist without a physician/NPP order
for non-acute hearing assessment unrelated to disequilibrium, or
hearing aids or examinations for the purpose of prescribing, fitting,
or changing hearing aids; (service may be performed once every 12
months) to describe these audiology services furnished personally
[[Page 69659]]
by an audiologist without the order of the treating physician or other
practitioner. We noted that we believe that limiting the audiology
services that can be furnished without an order to include only hearing
conditions that are non-acute in onset and balance services (patients
with disequilibrium symptoms) by removing the CPT codes for vestibular
dysfunction would be appropriate to address our patient safety
concerns. We also proposed to specify in the code descriptor for HCPCS
code GAUDX that the audiology services can be performed only once every
12 months. We noted that we believe this limitation is appropriate to
avoid potential program integrity issues, such as audiologists billing
for GAUDX with a greater frequency, or providing services that are not
reasonable and necessary for the treatment of the patient's illness or
injury. We selected once every 12 months, rather than every 6 months,
for two reasons. The first is because 6 months did not seem long enough
for a new, non-acute hearing condition to arise, and if an acute
hearing condition were to onset, it would necessitate an evaluation
with a physician/NPP. The second reason is that, at any time, the
beneficiary may always elect to see their physician/NPP for any hearing
conditions--acute or non-acute--or for conditions with disequilibrium
symptoms.
As proposed, an audiologist would be able to bill code GAUDX once
every 12 months for a beneficiary. The GAUDX code would include and be
used to bill for any number of audiology services furnished in that
particular encounter with the beneficiary. Since the proposed GAUDX
code is generic, the tests provided could include those that are split
into PC/TC and those that are not. As with all services, the actual
tests provided and their results would need to be documented in the
medical record, for purposes of medical review. Further, we proposed
that no more than one unit of code GAUDX could be billed--that means
``1'' is inserted in the ``days or units'' block 24G on the CMS 1500
professional claim form. We noted concerns that beneficiaries may
receive services billed as code GAUDX from more than one audiologist in
the 12-month period and/or be mistaken or misled into thinking that
code GAUDX represents a screening/preventive service which Medicare
does not cover. To avoid the potential for inappropriate use of HCPCS
code GAUDX, we explained that we plan to establish system edits through
our usual change management process to ensure that GAUDX is only paid
once every 12 months, per each beneficiary. We noted that the code
descriptor proposed for GAUDX could be billed for patients seeking care
for non-acute hearing conditions, and that the furnished audiology
services would still have to be medically necessary. As proposed, after
receiving audiology services from an audiologist accessed directly
without the order of a treating physician or practitioner, the
beneficiary would have to wait a full 12 months before receiving
additional diagnostic tests from an audiologist without a physician/NPP
order. The beneficiary would remain free to seek care from a treating
physician (or/NPP) if needed, and that care could potentially include a
referral with an order for further diagnostic testing furnished by an
audiologist.
To value HCPCS code GAUDX, we proposed to use the combined values
of CPT codes 92557 (Comprehensive audiometry threshold evaluation and
speech recognition (92553 and 92556 combined)) and 92567 (Tympanometry
(impedance testing)), which we believe would represent a typical
service provided by audiologists. We explained that we chose CPT Codes
92557 and 92567 as typical because they make up 72 percent of all
billings for audiologists; and, when all physician and practitioner
specialties are considered, including audiologists, CPT code 92557 is
billed with CPT code 92567 over 60 percent of the time and CPT code
92567 is billed with CPT code 92557 over 83 percent of the time in the
same clinical encounter, according to Medicare claims data.
Thus, we proposed a total work RVU of 0.8 for GAUDX, calculated by
combining the 0.60 work RVU for CPT code 92557 and 0.20 work RVU for
CPT code 92567. We proposed to establish the PE value for GAUDX by
combining the unduplicated PE of CPT codes 92557 and 92567.
Specifically, we proposed to include the following direct practice
expense (PE) inputs for supply items: two SD046 (Ear tip, tympanometry
probe), two SJ053 (Swab pad, alcohol), one SM0251 (Specula tips,
otoscope), one (SK059) sheet of recording paper, and two SD047 (Ear tip
insert with sound tube); and the following direct PE inputs for
equipment: EQ054 (Audiometric soundproof booth (exam and control room))
for 20 minutes, EQ053 (Audiometer, clinical, diagnostic) for 20
minutes, and EQ244 (Tympanometer with printer) for 4 minutes. We also
proposed to apply the same provisions for code GAUDX as those set for
CPT codes 92557 and 92567 (for example, PC/TC indicator, bilateral
indicator, physician supervision indicator, etc.), as they now appear
in the PFS Relative Value file found at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.
We discussed in the proposed rule that we believe that proposed
HCPCS code GAUDX, if finalized, will allow us to better understand the
scope of beneficiary access to these services with or without the order
requirement. We also noted that we believe that proposed HCPCS code
GAUDX, if finalized, will allow us to better assess possible burdens to
the beneficiary when attempting to access these services. We noted
that, given the makeup and intended use of proposed code GAUDX, we
would like to increase our understanding about how and where these
audiology services would be provided without the order of a treating
physician or practitioner. We requested comments from interested
parties about what settings might represent the typical places of
service and which institutional providers might bill for HCPCS code
GAUDX.
The following is a summary of the public comments received on the
Proposal to Allow Audiologists to Furnish Certain Diagnostic Tests
Without a Physician Order and our responses:
Comment: One commenter informed us that the final three codes
listed in Table 29 of the proposed rule (Proposed Codes for Tests that
can be Encompassed by HCPCS Code GAUDX . . .) were transcribed
incorrectly as CPT codes 92561, 92562, and 92563. However, the correct
codes related to auditory evoked potential (AEP) testing are CPT codes
92651, 92652, 92653.
Response: We agree that we included the incorrect codes in Table 29
of the proposed rule. We have corrected our error, and the correct AEP
testing codes now appear below in Table 36 as part of our final policy.
Comment: Several commenters supported the proposal to provide a
limited list of codes that could be provided without the treating
physician/NPP order. However, many of these commenters did not support
the use of the HCPCS code GAUDX, recommending that the existing CPT
codes should be billed and paid at the PFS rate. A few commenters
(including the RUC) specifically disagreed with our proposed G-code
valuation process, telling us that it would not preserve relativity
with other codes in the family, and does not reflect the clinical input
and expertise of the audiologists that furnish the services.
Response: We appreciate that interested parties supported our
[[Page 69660]]
proposal for a limited code set that would allow for direct access to
audiologists, without a physician/NPP order, for non-acute hearing
assessments unrelated to disequilibrium. We also appreciate hearing the
commenters' thoughts about the valuation of code GAUDX, as well as the
commenters' recommendations to use the CPT codes to bill for these
services, instead of the proposed GAUDX code. We agree with the
commenters about the usefulness of the CPT codes listed in Table 36, as
we detail in our final policy below.
Comment: We heard from several commenters who opposed our proposal
to provide for limited direct access to audiologists without a
physician/NPP order, and most of these commenters asked us to reverse
our proposal. A few commenters explained that they opposed the proposal
because physicians have more education and training than audiologists,
and this additional training enabled them to treat patients
holistically, yielding a better ability to treat and diagnose the
serious medical conditions associated with hearing loss. Most of these
commenters noted that there are negative consequences of removing
physicians from the care team. One commenter stated they would
conditionally support our proposal as long as we did not revise our
current safeguards (that is, direct access to audiologists for nonacute
hearing assessments unrelated to disequilibrium), because they have
consistently stood against a ``blanket'' direct access to audiologist
services without the order of a physician or practitioner, believing
that such broadly available direct access will generate considerable
patient safety and cost consequences without yielding significant
improvements to access to care. This commenter also suggested that CMS
should make payment to audiologists using the CPT codes based on the
valuations CMS adopts after review through the RUC process, rather than
using the proposed CMS-valued GAUDX code. Further, the commenter
requested that CPT code 92640 (for programming of an auditory brainstem
implant (ABI)) be removed from the list of 36 codes that are permitted
without an order. The commenter stated that because this service
carries risk of stimulating part of the brainstem and associated
cardiac events, a physician should supervise the first activation
provided by the audiologist.
Response: We appreciate the commenters' views, but we do not agree
that we should withdraw our proposal. As we noted above, we believe it
would be appropriate to provide a limited exception to the order
requirement for diagnostic hearing testing services furnished by
audiologists in order to broaden patient access to these services. We
appreciate the commenter that expressed their conditional support for
limited direct access to audiology services without a physician or NPP
order with the proposed safeguards that are built into the GAUDX long
descriptor. We further explain these safeguards below in the discussion
of our final policy. We also appreciate the commenter's recommendation
to remove the initial episode of CPT code 92640 (for ABI programming)
from the set of codes for services that could be furnished without a
physician or NPP order under the proposed policy, and remind the
commenter that the presence of a code on the list does not preclude a
physician (including the ABI surgeon) or NPP from writing an order for
this service. Moreover, we anticipate that most physicians will write
an order for the initial ABI programming upon discharge from this
brainstem surgery. We plan to gather data about audiologists' use of
CPT code 92640 without a physician or NPP order, and will consider this
recommendation in future rulemaking.
Comment: Several commenters disagreed with the safety concerns we
discussed in the proposed rule. Several commenters stated that
audiology malpractice insurance is very low, and that, if there were
safety risks, it would be higher than what they currently pay, which is
around $500 each year. A few commenters noted that delaying care until
the patient can obtain an order from a physician/NPP could
inadvertently have harmful consequences--noting that untreated hearing
loss over time can increase the likelihood of falls, social isolation,
and accelerated cognitive decline. Another commenter stated that
audiologists are qualified to identify, diagnose, manage, and treat
disorders of hearing and balance and have the training and knowledge to
recognize conditions needing medical treatment, as well as an ethical
obligation to refer patients that require medical services.
Response: The patient safety concerns discussed in the proposed
rule were related to the lack of involvement of a treating physician or
NPP with Medicare beneficiaries seeking hearing and balance services
directly from audiologists. There may be certain acute conditions and/
or symptoms that need to be medically diagnosed and treated on an
emergent basis by a physician or NPP. We continue to believe that
beneficiaries with acute hearing loss and disequilibrium symptoms need
to be medically managed, due to the potential for serious underlying
pathology, such as strokes or heart attacks, if such appropriate
identification and care are delayed. As we gain experience and
information under the direct access policy we are finalizing, we may
consider these issues further in future rulemaking.
Comment: Several audiologist commenters stated that, while they
appreciated CMS' proposal to remove physician/NPP order requirements as
a first step, they otherwise found the proposed HCPCS code GAUDX to be
impracticable, and thought that it would limit beneficiary access to
care and add a significant administrative burden to audiologists. These
commenters suggested that CMS should recognize the vestibular codes as
part of the direct access proposal allowing audiologists to provide
service(s) without a physician/NPP order, allow direct access for both
acute and nonacute hearing and balance conditions, and remove the
requirement that the services described by HCPCS code GAUDX only be
furnished to a beneficiary once every 12 months. These commenters
disapproved of the valuation of GAUDX, and its use as an umbrella code
to encompass the 36 different codes, as it would sometimes overpay for
the services provided and underpay for other services. One commenter
noted the GAUDX value is approximate $30-$100 less than the value of
each cochlear implant-related service, and asked that these codes be
removed from the GAUDX umbrella, because the cochlear implant centers
would be disproportionately financially impacted. Instead, many
commenters requested that some or all of the CPT codes proposed for
inclusion in the GAUDX code be used together with a new modifier that
could be used for services personally provided by an audiologist
without a physician/NPP order. A few of these commenters suggested that
the GAUDX code should encompass a smaller subset of codes than the
codes listed in Table 29 of the proposed rule, so that more codes would
be paid at CPT code-specific rates, even if they require a physician
order. One commenter suggested that CMS consider the use of a modifier
for even a smaller subset of the existing CPT codes for services
provided by an audiologist without an order, rather than finalizing the
GAUDX code (even if this reduces access to audiologists without an
order), if the full list of 36 codes was unworkable for CMS. Another
commenter submitted a suggested list of 7 codes that audiologists would
provide without a referral that could be billed with a
[[Page 69661]]
modifier in place of the GAUDX code, and another list of 7 codes for
services specific to a cochlear implant, auditory osseointegrated
implant (AOI), or ABI (but the commenter was unclear as to the
requirements for each list). Several commenters also submitted a list
of CPT codes that are specific to the services surrounding cochlear
implants, AOIs, and ABIs, such as evaluation to determine candidacy for
an implanted hearing device and post-surgical evaluation of performance
(for example, cochlear, AOI, or ABI implants), as well as for
diagnostic analysis and subsequent reprogramming of the cochlear
implant, AOI or ABI. The commenters suggested that these codes could be
billed with the potential modifier for direct access to an audiologist,
noted that the clinical standard of care for some of these services
requires them to be repeated more often than once every 12 months. The
commenters explained that the audiologist does not need an order from a
physician or NPP for these services because the patient's physician and
implanting surgeon are involved with these patients and, suggested that
the order requirement presents a nuisance for the audiologist,
physician or surgeon, and beneficiary.
Response: We thank the commenters for their suggestions. We are
struck by the number of commenters that requested that we use a
modifier with the CPT codes rather than the proposed GAUDX code, so
that audiologists could bill more accurately for the specific tests
they furnished and could be paid at the CPT code-specific PFS rates,
instead of at the single rate for code GAUDX (which bundled 36 services
of varying payment rates together). We also appreciate the suggestions
of some commenters to reduce the scope of services/codes that would
have been bundled under the GAUDX code, which would also allow them to
more specifically bill for the services furnished and be paid at rates
valued at the established value for those services. We note that
several commenters recommending that fewer services be included in the
proposed GAUDX code, even if it meant that a physician/NPP order would
be required for more services. We agree with commenters' overwhelmingly
consistent recommendations to use a modifier instead of the proposed
HCPCS code GAUDX, as explained in the description of our final policy
that follows. We would like to point out that a given modifier would
only have one descriptor and uniform rules/restrictions, but it would
allow for greater specificity in billing and payment for services as
suggested by commenters. All of the commenters that supported the use
of the modifier generally disfavored the proposed GAUDX code because,
as we noted above, the valuation of GAUDX would potentially overpay for
some services and underpay for others. We agree that appending a
modifier to the specific CPT code for the service furnished will more
accurately pay for the specific service furnished. Additionally, the
use of a modifier with the specific CPT codes for services furnished by
audiologists without an order will allow CMS to track the actual
services that are being by audiologists without the physician or NPP
order. We also believe that use of a modifier will reduce burden for
audiologists as compared to using a new code, because audiologists are
familiar with the code set and are currently using these codes to bill
for services. Using a modifier allows audiologists to more specifically
identify and bill be paid for the services they furnish, as opposed to
billing using one code that is paid at the proposed bundled rate across
the 36 codes, and allows CMS to have more detailed information on which
services are furnished through direct access to audiologists without an
order.
Comment: Several audiologist commenters questioned how to handle
situations in cases where patients directly access an audiologist, but
may be uncertain whether they have seen a different audiologist without
an order of their physician or NPP in the past 12 months. They
questioned whether billing GAUDX more frequently than once every 12
months requires an Advanced Beneficiary Notice (ABN) where there is no
physician or NPP order, to transfer financial responsibility to the
beneficiary. Another commenter asked whether they need to keep a
voluntary or mandatory ABN on file in case the GAUDX claim is rejected
to avoid the financial responsibility themselves. Several commenters
noted that a CMS-developed, real-time, online tool should be made
available for them to ascertain the needed eligibility information, so
that an ABN can be administered to the beneficiary when necessary.
Response: We appreciate these comments and plan to communicate how
audiologists can best prepare for and handle these types of situations
through healthcare provider education vehicles and other guidance.
Comment: Some commenters requested more context surrounding the
nonacute terminology and how it applies to nonacute hearing assessments
that are unrelated to disequilibrium.
Response: For purposes of the audiology direct access policy,
including all the 36 codes listed in Table 36, acute hearing loss
involves a sudden onset in one or both ears--and is a perceived change
in hearing by a beneficiary that is not consistent with the progressive
loss of hearing over many years that is typical with the aging process.
A nonacute hearing loss is a more gradual hearing loss that one may
experience with advancing age, known as presbycusis, which the National
Institute on Deafness and Other Communication Disorders defines as:
``Age-related hearing loss (presbycusis) is the loss of hearing that
gradually occurs in most of us as we grow older. Age-related hearing
loss most often occurs in both ears, affecting them equally.''
Audiologists can furnish services among those listed in Table 36, the
results of which can provide essential information for them to
recommend, for example, further testing or a medical referral to the
patient's treating physician or NPP. It is for these nonacute types of
gradual hearing loss and for hearing loss that is treated via
surgically implanted hearing devices such as cochlear implants, AOIs,
and auditory brainstem implants (discussed above) that beneficiaries
may be seen by the audiologist without a physician/NPP order.
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After consideration of public comments received, we are finalizing
amendments to the regulation at Sec. 410.32(a)(4) with modifications
effective for services furnished on or after January 1, 2023. We
proposed to allow audiologists to furnish the services included on a
list of 36 services without a physician order (as listed in Table 36
(which we corrected to identify CPT codes, 92651, 92652, and 92653). We
are finalizing our proposal that these services can be covered and paid
when furnished without the order of the treating physician or NPP for
non-acute hearing assessment unrelated to disequilibrium, or hearing
aids, or examinations for the purpose of prescribing, fitting, or
changing hearing aids (in alignment with statutory and regulatory
restrictions); that the services may be performed once every 12 months
per beneficiary. We are not finalizing our proposal to create G-code
(GAUDX) for use to bill for audiology services furnished without the
order of a physician or NPP. Instead, audiologists are to use the
individual CPT codes to identify the services they furnish without the
order of a physician or NPP, within the list of 36 allowed services
(Table 36), and append a new modifier we will create (modifier AB). We
were persuaded by comments from interested parties to use the modifier
approach, which allows us to better identify which services are
actually furnished (as opposed to the bundled GAUDX code) and reduces
burden for audiologists, who already are familiar with the relevant CPT
codes. In the last sentence of Sec. 410.32(a)(4), we are replacing the
proposed term ``code'' with the term ``modifier'' so that the final
sentence of Sec. 410.32(a)(4) will now state that audiology services
furnished without an order from the treating physician or NPP are
billed using a modifier CMS designates for this purpose.
The AB modifier will be used together with the 36 CPT codes on
Table 36 (which has been updated from Table 35 to reflect the corrected
CPT code numbers--92651, 92652, and 92653--as
[[Page 69663]]
discussed above), to indicate that the service/test was provided on a
single treatment day, without an order from the physician/NPP treating
the patient. We continue to believe that the patient safety, medical
necessity, and program integrity safeguards we proposed are
appropriate. Therefore, we are finalizing our proposal to limit direct
access to audiology services without the order of the treating
physician or NPP to non-acute hearing services to services listed in
Table 36, and to establish a once per 12-month frequency limitation.
These limitations on audiology services furnished without the order of
the treating physician or NPP, which were proposed for HCPCS code
GAUDX, will be reflected in the descriptor for the new AB modifier.
Additionally, to align our final policy to use the modifier instead of
HCPCS code GAUDX with the once per 12-month limitation, we are further
modifying our final policy for use of the modifier with the codes
available (please refer to Table 36). If an audiologist furnishes one
or more services on the list of available codes without the order of a
physician or NPP on a single date of service, the AB modifier must be
appended to each of the CPT codes billed for that date of service, and
all of the services will be considered payable. However, if a service
is billed with the AB modifier on one date of service and the
beneficiary returns at a later date for another service (without an
order) and that service is within the 12-month period after the prior
service is furnished (either for the same or a different service on the
list in Table 36), then the subsequent service(s) would not be
considered payable under the PFS.
Aligning our final policy to use modifier AB instead of HCPCS code
GAUDX necessitates multiple changes to our claims processing systems,
which will take some time to operationalize, possibly until mid-year
2023. Until such time, audiologists may use the AB modifier that is
available for dates of service on and after January 1, 2023 to provide
services/tests to beneficiaries who have directly accessed their
services. Audiologists who furnish these services without an order are
expected to follow our policy and safeguards built into the AB
modifier, as above and in the code descriptor below. As we noted above,
we plan to communicate to audiologists via provider education and other
guidance, including the Audiology Services web page page at https://www.cms.gov/audiology-services.
The long descriptor for Modifier AB is as follows: Audiology
service furnished personally by an audiologist without a physician/npp
order for non-acute hearing assessment unrelated to disequilibrium, or
hearing aids, or examinations for the purpose of prescribing, fitting,
or changing hearing aids; service may be performed once every 12
months, per beneficiary.
L. Medicare Parts A and B Payment for Dental Services
1. Background on Medicare Payment for Dental Services
Section 1862(a)(12) of the Act generally precludes payment under
Medicare Parts A or B for any expenses incurred for services in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth. (Collectively here,
we will refer to ``the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth'' as
``dental services.'') That section of the statute also includes an
exception to allow payment to be made under Medicare Part A for
inpatient hospital services in connection with the provision of such
dental services if the individual, because of their underlying medical
condition and clinical status or because of the severity of the dental
procedure, requires hospitalization in connection with the provision of
such services. Our regulation at 42 CFR 411.15(i) similarly excludes
payment for dental services except for inpatient hospital services in
connection with dental services when hospitalization is required
because of: (1) the individual's underlying medical condition and
clinical status; or (2) the severity of the dental procedure.
However, under our current policy, we make payment under both
Medicare Parts A and B for certain dental services in circumstances
where the services are not considered to be in connection with dental
services within the meaning of section 1862(a)(12) of the Act or our
regulation at Sec. 411.15(i). We make payment when a doctor of dental
medicine or dental surgery (hereinafter referred to as a ``dentist'')
furnishes dental services that are an integral part of the covered
primary procedure or service furnished by another physician treating
the primary medical illness. In these limited circumstances, Medicare
payment can be made for dental services such as, but not limited to,
the wiring of teeth when done in connection with a reduction of a jaw
fracture, the extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease, and/or an oral or dental examination
on an inpatient basis performed as part of a comprehensive workup prior
to renal transplant surgery. (See Medicare Benefit Policy Manual (IOM
Pub 100-02, Chapter 15, section 150); and Medicare National Coverage
Determinations Manual Chapter 1, Part 4 (IOM Pub 100-03, Chapter 1,
Part 4, section 260.6)). Medicare Administrative Contractors (MACs)
make claim-by-claim determinations as to whether a patient's
circumstances do or do not fit within the terms of the preclusion and
exception specified in section 1862(a)(12) of the Act and Sec.
411.15(i) of our regulations, and in accordance with the CMS manual
provisions.
As described in the CY 2023 PFS proposed rule (87 FR 45860, 46033
and 46034), we have received feedback from interested parties
suggesting that our interpretation of section 1862(a)(12) of the Act is
unnecessarily restrictive, which may contribute to inequitable
distribution of dental services for Medicare beneficiaries.
Additionally, a recent report from the National Institutes of Health,
``Oral Health in America Advances and Challenges,'' discusses how
unequal distribution of dental services and prohibitive costs,
particularly for older adults who are at the highest risk for poor oral
health, can lead to and further complicate the treatment of other
medical conditions (for more information, see https://directorsblog.nih.gov/2022/06/14/using-science-to-solve-oral-health-inequities/). The interested parties also suggested that there are
instances where dental services are directly related to the clinical
success of an otherwise covered medical service under Medicare Parts A
and B, and that the regulation at Sec. 411.15(i) should be amended to
reflect that Medicare payment is available in these circumstances.
Recognizing that there may be instances where medical services
necessary to diagnose and treat the individual's underlying medical
condition and clinical status may require the performance of certain
dental services, we stated that we believe that there are instances
where dental services are so integral to other medically necessary
services that they are not in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting teeth within the meaning of section 1862(a)(12) of the Act.
Rather, such dental services are inextricably linked to the clinical
success of an otherwise covered medical service, and therefore, are
instead substantially related and integral to that primary medical
service. We also stated that we believe that there are circumstances
where the dental services are in direct connection with the care,
[[Page 69664]]
treatment, filling, removal, or replacement of teeth or structures
directly supporting teeth, and are not inextricably linked to the
clinical success of a covered medical service. In these instances, we
continue to believe that Medicare payment is precluded by section
1862(a)(12) of the Act except when, due to the patient's underlying
medical condition and clinical status, or the severity of the dental
procedure, hospitalization is required; and that in those instances,
the Medicare Part A exception provided under section 1862(a)(12) of the
Act would apply.
To provide greater clarity to our current policies and respond to
issues raised by interested parties, in the CY 2023 PFS proposed rule
(87 FR 45860, 46033 through 46041) we: (1) proposed to clarify our
interpretation of section 1862(a)(12) of the Act and codify certain of
our current Medicare FFS payment policies for medically necessary
dental services; (2) proposed and sought comment on payment for other
dental services, such as dental examinations, including necessary
treatment, performed as part of a comprehensive workup prior to organ
transplant surgery, or prior to cardiac valve replacement or
valvuloplasty procedures, that are similarly inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services; (3) requested comments on other
types of clinical scenarios where the dental services may be
inextricably linked to, and substantially related and integral to the
clinical success of, other covered medical services; (4) requested
comments on the potential establishment of a process to identify for
our consideration and review submissions of additional dental services
that are inextricably linked and substantially related and integral to
the clinical success of other covered medical services; (5) requested
comment on other potentially impacted policies; and (6) requested
comment on potential future payment models for dental and oral health
care services. We sought public comments on these proposals and issues.
2. Clarifying the Interpretation of Section 1862(a)(12) of the Act and
Codifying Current Payment Policies for Certain Dental Services
a. Payment for Inpatient Hospital Dental Services
As explained above and in the CY 2023 PFS proposed rule (87 FR
45860, 46033 and 46034), under our interpretation of the statute and
our current regulation, and as reflected in our regulation and manuals,
items and services furnished in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting the teeth generally are not covered, and no payment may be
made for them under either Medicare Part A or Part B. Section
1862(a)(12) of the Act and our regulation at Sec. 411.15(i) include an
exception to allow Medicare Part A payment to be made for inpatient
hospital services in connection with the provision of dental services
if the individual, because of their underlying medical condition and
clinical status or because of the severity of the dental procedure,
requires hospitalization in connection with the provision of such
services. We stated that we believe that there are instances in which a
Medicare beneficiary may require dental services that are in direct
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth such that the
application of the Medicare Part A payment exception would apply when
hospitalization is required because of: (1) a patient's underlying
medical condition and clinical status; or (2) the severity of the
dental procedure. Under these circumstances, we would continue to apply
the exception under section 1862(a)(12) of the Act, and make payment
for inpatient hospital services. We solicited public comments on what
professional services, including, but not limited to dental services,
may occur during and prior to the patient's hospitalization or
procedure requiring hospitalization under this exception. We noted in
the proposed rule that we may consider finalizing, based on our review
of public comments, additional payment policies in this area.
b. Clarifying the Interpretation of Section 1862(a)(12) of the Act and
Codifying Current Payment Policies for Certain Dental Services
As explained above, Medicare payment can be made for inpatient
hospital services associated with dental services that fall within the
statutory exception under section 1862(a)(12) of the Act. However,
under our current policy, if a dental service and other related
services (for example, anesthesia or imaging services) are performed as
incident to and as an integral part of a covered procedure or service
performed by a dentist, the total service performed by the dentist is
covered, and payment can be made under Medicare Parts A and B as
appropriate. This policy is based on the idea that some dental services
that would ordinarily be excluded by statute from payment are
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services. When that
is the case, we stated that then we believe those dental services are
not in connection with dental services within the meaning of section
1862(a)(12) of the Act, but are instead inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services. As such, we proposed to interpret the
statute under section 1862(a)(12) of the Act to permit Medicare payment
under Parts A and B for dental services where the dental service is
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services and allow
payment to be made, regardless of whether the services are furnished in
an inpatient or outpatient setting. Under these circumstances, we
proposed that the exclusion under section 1862(a)(12) of the Act would
not apply, because the service is not in connection with the care,
treatment, filling, removal, or replacement of the teeth or structures
supporting the teeth, but instead is inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services.
As described in section II.L.1. of the proposed rule, in a limited
number of circumstances, Medicare Part B currently pays for dental
services under the PFS when a dentist furnishes a service(s) that is
integral to the covered primary procedure or service rendered when
treating the primary medical illness. Our current payment policies for
dental services are contained in manual provisions (The Medicare
Benefit Policy Manual Chapter 15 (IOM Pub 100-02, Chapter 15, section
150) and Medicare National Coverage Determinations Manual Chapter 1,
Part 4 (IOM Pub 100-03, Chapter 1, Part 4, section 260.6)) that reflect
the proposed interpretation of section 1862(a)(12) of the Act discussed
in the proposed rule.
Our payment policy contained in Medicare National Coverage
Determinations Manual Chapter 1, Part 4 (IOM Pub 100-03, Chapter 1,
Part 4, section 260.6) \112\ (herein ``the NCD Manual'') provides for
payment of an oral or dental examination performed on an inpatient
basis as part of a comprehensive workup prior to renal transplant
surgery. In the CY 2023 PFS proposed rule (87 FR 45860, 46035), we
stated that we believe Medicare
[[Page 69665]]
payment is permitted under this manual provision for such a dental or
oral examination prior to renal transplant surgery, because the
examination is inextricably linked to, and substantially related and
integral to the clinical success of, the renal transplant procedure. As
such, we stated that we believe such services are not subject to the
payment preclusion under section 1862(a)(12) of the Act. However, we
also stated that we believe that comprehensive workups prior to renal
transplant surgery, including related dental examinations, can occur in
either the inpatient and outpatient setting. As such, we proposed to
provide Medicare payment for oral or dental examinations performed as
part of a comprehensive workup prior to renal transplant surgery when
these services occur in either the inpatient or outpatient setting, and
revise our regulation at Sec. 411.15(i) accordingly.
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\112\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
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We noted that the NCD Manual states that, when performing a dental
or oral examination, a dentist is not recognized as a physician under
section 1861(r) of the Act. We stated that we believe this statement is
based on an unnecessarily narrow reading of section 1861(r) of the Act,
and is also not consistent with other manual provisions. The statutory
definition of physician includes a doctor of dental surgery or dental
medicine in section 1861(r)(2) of the Act, and a similar definition of
physician is included in our IOM Pub 100-1, Section 70.2\113\ when
dental or oral examinations, and specific treatments, are within the
State scope of practice for the dentist. As such, we proposed to amend
Sec. 411.15(i) to clarify that Medicare Part B coverage and payment
can be made for such a dental or oral examination prior to renal
transplant surgery when performed by a doctor of dental surgery or
dental medicine as defined in section 1861(r)(2) of the Act.
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\113\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS050111.
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The Medicare Benefit Policy Manual Chapter 15 (IOM Pub 100-02,
Chapter 15, section 150) (herein ``the MBP Manual'') states that if an
otherwise noncovered procedure or service is performed by a dentist as
incident to and as an integral part of a covered procedure or service
performed by the dentist, the total service performed by the dentist on
such an occasion is covered.\114\ The MBP Manual continues by providing
several specific examples where CMS would pay for dental services:
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\114\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS012673.
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The reconstruction of a ridge when it is performed as a
result of and at the same time as the surgical removal of a tumor
(other than for dental purposes).
The wiring of teeth when done in connection with the
reduction of a jaw fracture.
The extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease.
The dental splint when performed in conjunction with
treatment that is determined to be a covered medical condition.
Specifically, in the MBP Manual, we describe that the
reconstruction of a ridge performed primarily to prepare the mouth for
dentures is a noncovered procedure and therefore would not generally be
eligible for payment. However, when the reconstruction of a ridge is
performed as a result of and at the same time as the surgical removal
of a tumor (for other than dental purposes), the totality of surgical
procedures is a covered service. In the case of the procedure of ridge
reconstruction occurring in conjunction with the surgical removal of a
tumor, we believe that the dental services are inextricably linked to,
and substantially related and integral to the clinical success of, the
other covered medical services, that is, the removal of a tumor; and
therefore, Medicare Parts A and B payment could be made. Additionally,
the MBP Manual explains that Medicare makes payment for the wiring of
teeth when this is done in connection with the reduction of a jaw
fracture. Once again, we stated that we believe that the dental
services of wiring of the teeth are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services, which in this case is the reduction of
a jaw fracture, and therefore, Medicare Parts A and B payment could be
made. Likewise, the MBP Manual states that the extraction of teeth to
prepare the jaw for radiation treatment of neoplastic disease is also
currently covered. We continue to believe that in this clinical
scenario the dental services related to teeth extraction are
inextricably linked to, and substantially related and integral to the
clinical success of, the radiation treatment of neoplastic disease; and
therefore, Medicare Parts A and B payment could be made. The Manual
also describes a specific situation in which certain dental services
may be considered a covered service, depending on whether the
underlying medical condition is deemed to be covered. The Manual
explains that dental splints used to treat a dental condition are
generally excluded from coverage under section 1862(a)(12) of the Act,
but if the treatment is determined to be a covered medical condition
(that is, dislocated upper/lower jaw joints), then the splint can be
covered. We stated that we believe that dental splint services could be
covered and paid, because the dental services could be inextricably
linked to, and substantially related and integral to the clinical
success of, a covered medical service, such as treatment of a
dislocated jaw. Therefore, we proposed to clarify and modify the
regulations text at Sec. 411.15(i) to include this scenario of dental
splints used in the treatment of a covered medical condition. We sought
comments on this aspect of the proposal.
Therefore, we proposed to codify and clarify in the regulation at
Sec. 411.15(i) that payment can be made under Medicare Parts A and B
for dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services, including (1) reconstruction of a ridge when it is
performed as a result of and at the same time as the surgical removal
of a tumor; (2) the wiring or immobilization of teeth when done in
connection with the reduction of a jaw fracture; (3) the extraction of
teeth to prepare the jaw for radiation treatment of neoplastic disease;
and (4) a dental splint only when used in conjunction with covered
treatment of a medical condition. This provision would clarify existing
policy, as we are codifying existing manual provisions in regulation.
The MBP Manual states that payment can be made under Medicare Parts
A and B for a covered dental procedure regardless of where the service
is performed, noting that the hospitalization or non-hospitalization of
a patient has no direct bearing on the coverage, payment, or exclusion
of a given dental procedure in specific circumstances. As such, dental
services that are not excluded from Medicare payment under section
1862(a)(12) of the Act could be appropriately furnished in inpatient or
outpatient settings. We proposed to clarify in the regulation at Sec.
411.15(i) that payment for dental services that do not fall within the
scope of section 1862(a)(12) of the Act, and that are inextricably
linked to, and substantially related and integral to the clinical
success of, certain other covered medical services, could be made
regardless of whether the services are furnished on an inpatient or
outpatient basis. We sought comments on whether it is clinically
appropriate for these services to be furnished in inpatient or
outpatient settings.
[[Page 69666]]
The MBP Manual further states that the coverage of services such as
the administration of anesthesia, diagnostic x-rays, and other related
procedures depends upon whether the primary procedure being performed
by the dentist is itself covered. The MBP Manual explains that an x-ray
taken in connection with the reduction of a fracture of the jaw or
facial bone is covered, while a single x-ray or x-ray survey taken in
connection with the care or treatment of teeth or the periodontium is
not covered. In order to clarify and codify this current policy, we
proposed to amend our regulation at Sec. 411.15(i) to provide that
payment can be made for dental services provided in conjunction with
medical services that are inextricably linked to, and substantially
related and integral to the clinical success of, covered medical
services, such as X-rays, administration of anesthesia, and use of the
operating room.
The MBP Manual also specifies that payment can be made for services
and supplies furnished incident to other dental services for which
Medicare payment can be made, for example, services furnished incident
to the dentist's professional services by a dental technician or
registered nurse under the dentist's direct supervision. Medicare
payment policy for services furnished incident to the services of the
billing practitioner are contained in Sec. 410.26 of our regulations.
Additionally, the MBP Manual provides that when an excluded service
is the primary procedure involved, dental services are not covered,
regardless of complexity or difficulty. The MBP Manual describes an
example of the extraction of an impacted tooth as not covered, and goes
on to state that certain procedures, including an alveoplasty (the
surgical improvement of the shape and condition of the alveolar
process) and a frenectomy, are excluded from coverage when either of
these procedures is performed in connection with an excluded service,
for example, the preparation of the mouth for dentures. Additionally,
the MBP Manual states that the removal of a torus palatinus (a bony
protuberance of the hard palate) may be a covered service, but notes
that it is often provided in connection with an excluded service (that
is, the preparation of the mouth for dentures), and in that event,
Medicare does not pay for this procedure.
We did not propose to modify this policy. No payment is made for
dental services when an excluded service is the primary procedure
involved. Our interpretation of section 1862(a)(12) of the Act allows
for Medicare payment when dental services are inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services. Therefore, no payment is made
when dental services are related to medical services that are not
covered, even if the dental services are inextricably linked to, and
substantially related and integral to the clinical success of, the non-
covered services. We stated that the proposed amendment to Sec.
411.15(i) would specify that, in order for Medicare payment to be made,
the dental services must be inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services.
As proposed, the provision to clarify and codify our current
payment policy for dental services, section 1862(a)(12) of the Act does
not apply only when dental services are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services, such that the standard of care for that
medical service would be compromised or require the dental services to
be performed in conjunction with the covered medical services. When
such medically necessary dental services are furnished by a physician
or practitioner, including a dentist, Medicare Part A or B payment can
be made for the dental services and other services integral or incident
to those dental services. Specifically, such services include:
The wiring of teeth when done in connection with an
otherwise covered medical service,
The reduction of a jaw fracture (such as services
described by CPT code sets 21440-21490),
The extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease (such as services described by Current
Dental Terminology (CDT) \115\ codes D7140 and D7210 for ICD-10 C41.1
Malignant neoplasm of mandible),
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\115\ https://www.ada.org/publications/cdt.
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Dental splints only when used in conjunction with covered
treatment of a medical condition (such as dislocated upper/lower jaw
joints), or
An oral or dental examination performed as part of a
comprehensive workup prior to renal transplant surgery (such as
services described by ICD-10 Z94.0, and codes D0150, D0180, or D0160).
We proposed that Medicare Parts A and B payment for these dental
services can be made, because the services are inextricably linked to,
and substantially related and integral to the clinical success of, the
other covered medical services. We further sought comment on whether,
given current clinical advances, the descriptions of these dental
services are clinically accurate and appropriate. For example, we are
interested in whether the phrase ``wiring of the teeth'' is still
clinically accurate or if other terminology would be more appropriate.
Given that such dental services would not be subject to the
preclusion on payment under section 1862(a)(12) of the Act, Medicare
would make payment to the furnishing dentist or another physician or
practitioner for the professional dental services. As described in the
MBP Manual, payment may also be made for services and supplies
furnished incident to those dental services furnished by the dentist or
other physician or practitioner, and for other ancillary services
integral to the dental services. For example, Medicare payment could be
made for services furnished incident to the professional dental
services by auxiliary personnel, such as a dental hygienist, dental
therapist, or registered nurse who is under the direct supervision of
the furnishing dentist or other physician or practitioner, if they meet
the requirements for ``incident to'' services as described in Sec.
410.26 of our regulations. When such dental services are furnished in a
facility setting, such as an inpatient acute care hospital or hospital
outpatient department, payment for the facility or ancillary services
would be made under the applicable payment system.
In summary, we proposed to amend Sec. 411.15(i) to codify that
payment can be made under Medicare Parts A and B for dental services
that are inextricably linked to, and substantially related and integral
to the clinical success of, an otherwise covered medical service. We
further proposed to amend Sec. 411.15(i) to include examples of
services for which payment can be made under Medicare Parts A and B on
that basis. Specifically, we proposed to include as examples the
following dental services for which payment is permitted under our
current policy: (1) dental or oral examination as part of a
comprehensive workup prior to a renal organ transplant surgery; (2)
reconstruction of a dental ridge performed as a result of and at the
same time as the surgical removal of a tumor; (3) wiring or
immobilization of teeth in connection with the reduction of a jaw
fracture; (4) extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease; and (5) dental splints only when used
in conjunction with medically necessary treatment of a medical
condition. We further proposed
[[Page 69667]]
that Medicare payment would be made for these dental services
regardless of whether the services are furnished in an inpatient or
outpatient setting, and we proposed that payment can also be made for
services that are ancillary to these dental services, such as x-rays,
administration of anesthesia, use of an operating room, other facility
services.
We sought comment on all aspects of this proposal. We stated that,
if finalized, we would make conforming changes to the MBP Manual to
reflect changes or clarifications, and to remove any text that is no
longer applicable. We also noted that we would make conforming changes
to other Manual provisions or National Coverage Decision policies as
necessary.
As discussed, MACs may determine on a claim-by-claim basis whether
a patient's circumstances do or do not fit within the terms of the
preclusion or exception specified in section 1862(a)(12) of the Act and
Sec. 411.15(i). The proposed policies outlined in the proposed rule
would not prevent a MAC from making a determination that payment can be
made for dental services in other circumstances not specifically
addressed in the proposed rule and the proposed amendments to Sec.
411.15(i).
c. Update to Current Payment Policies for Dental Services
As discussed in section II.L.2 of the proposed rule, we proposed
that payment can be made under Medicare Parts A and B for dental
services such as the reconstruction of a dental ridge performed as a
result of and at the same time as the surgical removal of a tumor, the
wiring or immobilization of the teeth when done in connection with a
reduction of a jaw fracture, the extraction of teeth to prepare the jaw
for radiation treatment of neoplastic disease, dental splints only when
used in conjunction with covered treatment of a medical condition, and
an oral or dental examination performed as part of a comprehensive
workup prior to renal transplant surgery. We noted in the proposed rule
that we believe, after further review of current medical practice,
through consultations with interested parties and our medical officers,
that there are additional circumstances that are clinically similar to
these examples, and where Medicare payment for the service could be
made, because the dental services are inextricably linked to, and
substantially related and integral to the clinical success of, the
other covered medical service(s).
For example, after further review, we stated that we believe that
if a patient requiring an organ transplant has an oral infection, the
success of that transplant could be compromised if the infection is not
properly diagnosed and treated prior to the transplant surgery. Without
an oral or dental examination to identify such an infection, and the
necessary treatment, such as restorative dental services, to eradicate
it prior to the transplant procedure, the patient's ability to accept
the organ transplant could be seriously complicated or compromised.
Examples of restorative dental services to eradicate infection could
include: extractions (removal of the entire infection, such as pulling
of teeth--for example, CDT D7140, D7210), restorations (removal of the
infection from tooth/actual structure, such as fillings--for example,
CDT D2000-2999), periodontal therapy (removal of the infection that is
surrounding the tooth, such as scaling and root planing--for example,
CDT D4000-4999, more specifically D4341, D4342, D4335 and D4910), or
endodontic therapy (removal of infection from the inside of the tooth
and surrounding structures, such as root canal--for example, CDT D3000-
3999). If such an infection is not treated prior to transplant, and
immunosuppressant therapy is initiated to preserve the transplant, then
there is an increased likelihood for morbidity and mortality resulting
from spreading of the local infection to sepsis. Similarly, without a
dental or oral exam and necessary diagnosis and treatment of any
presenting infection of the mouth prior to a cardiac valve replacement
\116\ or valvuloplasty procedures, an undetected, non-eradicated oral
or dental infection could lead to bacteria seeding the valves, seeding
surrounding cardiac muscle tissues involved with the surgical site, and
conceivably leading to systemic infection or sepsis, all of which
increase the likelihood of unnecessary and preventable acute and
chronic complications for the patient. Because an oral or dental
infection can present substantial risk to the success of these
procedures, such that the standard of care would be to not proceed with
the procedure when there is a known oral or dental infection present,
we noted that we believe dental services furnished to identify,
diagnose, and treat oral or dental infections prior to organ
transplant, cardiac valve replacement, or valvuloplasty procedures are
not in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, but
instead are inextricably linked to, and substantially related and
integral to the clinical success of, these other covered medical
services. We noted that, in these circumstances, the necessary
treatment to eradicate an infection may not be the totality of
recommended dental services for a given patient. For example, if an
infected tooth is identified in a patient requiring an organ
transplant, cardiac valve replacement, or valvuloplasty procedure, the
necessary treatment would be to eradicate the infection, which could
result in the tooth being extracted. Additional dental services, such
as a dental implant or crown, may not be considered immediately
necessary to eliminate or eradicate the infection or its source prior
to surgery. Therefore, we stated that such additional services would
not be inextricably linked to, and substantially related and integral
to the clinical success of, the organ transplant, cardiac valve
replacement, or valvuloplasty services. As such, no Medicare payment
would be made for the additional services that are not immediately
necessary prior to surgery to eliminate or eradicate the infection.
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\116\ Knox, K.W., & Hunter, N. (1991). The role of oral bacteria
in the pathogenesis of infective endocarditis. Australian dental
journal, 36(4), 286-292. https://doi.org/10.1111/j.1834-7819.1991.tb00724.x.
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As discussed, we noted that we believe that there are circumstances
where the clinical success of medical or surgical services required for
a successful organ transplantation, cardiac valve replacement, and
valvuloplasty procedure may require the performance of certain dental
services. As such, we proposed to amend our regulation at Sec.
411.15(i)(3) to provide that dental services that are inextricably
linked to, and substantially related and integral to the clinical
success of, a certain covered medical service are not subject to the
exclusion under section 1862(a)(12) of the Act; and that payment can be
made under Medicare Parts A and B for such dental services. We proposed
to amend Sec. 411.15(i) to include examples of payable services under
Medicare Parts A and B, as: (1) the dental or oral examination as part
of a comprehensive workup prior to an organ transplant, cardiac valve
replacement, or valvuloplasty procedure; and (2) the necessary dental
treatments and diagnostics to eliminate the oral or dental infections
found during a dental or oral examination as part of a comprehensive
workup prior to an organ transplant, cardiac valve replacement, or
valvuloplasty procedure. We noted that we believe that clinical
practice is such that these services can occur within the inpatient
[[Page 69668]]
hospital or outpatient setting, and we further propose that Medicare
Parts A and B would make payment for these dental services, as
applicable, regardless of whether the services are furnished in an
inpatient or outpatient setting. Furthermore, we proposed that payment
under the applicable payment system could also be made for services
that are ancillary to these dental services, such as X-rays,
administration of anesthesia, and use of the operating room.
We sought comment on the proposed policy and our proposed
amendments to Sec. 411.15(i)(3) to specify that payment under Medicare
Parts A and B can be made for an oral or dental examination, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection, prior to an organ transplant, cardiac valve
replacement, or valvuloplasty procedure. We proposed to continue to
contractor price the dental services for which payment is made
currently, and for the dental services that can be made under the
proposed amendments to Sec. 411.15(i)(3) for CY 2023, or until we have
further data to establish prospective payment rates. We solicited
comment on the proposals, including the expected utilization of these
services discussed in our proposals.
i. Other Clinical Scenarios for Dental Services Integral to Other
Covered Medical Services
In addition to the examples of dental services for which payment is
made under our current policy, and dental services to avoid risk of an
oral or dental infection prior to organ transplant, cardiac valve
replacement, or valvuloplasty procedures, we stated that we believe
there may be other clinical scenarios where dental services may not be
in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, but
instead are inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services. These could include certain dental exams and medically
necessary diagnostic and treatment services prior to treatments for
head and neck cancers, such as radiation therapy with or without
chemotherapy, or the initiation of immunosuppressant therapy, such as
those used during cancer treatments, where the standard of care is such
that it is clinically advisable to eliminate the source of infection
prior to proceeding with the necessary medical care, or the standard of
care for the primary medical condition would be significantly
materially compromised if the dental services are not performed. As
with any assessment of patient health prior to initiating
immunosuppressant therapy, it may be necessary to eradicate all sites
of infection, including oral infections, prior to suppressing the
immune system, regardless of the reason for prescribing an
immunosuppressant. We also noted that some medications may have an
immunosuppressant effect, even though they are not prescribed
principally to suppress the immune system. We stated that we believe,
in these circumstances, eradicating oral or dental infection prior to
beginning a medication that has been found to have a suppressant effect
on that part of the immune system required to eradicate infectious
agents could be necessary to the clinical success of the medication
therapy.
Similarly, in joint replacement surgery (such as total hip and knee
arthroplasty surgery) we stated that we believe there may be risks to
the outcome of the procedure if an oral infection is not treated. There
is evidence that some joint replacement patients have significant
dental pathology found before their surgery.\117\ Given the incidence
of dental pathology in joint replacement patients, there may be some
joint replacement patients who would experience a clinically
significant benefit from a pre-operative dental exam and medically
necessary treatment of oral pathology(ies). As in transplant surgery,
patients having joint replacement surgery are at risk for surgical site
infection, and there may be an increased risk for those patients with
significant dental pathology. The presence of an overlooked oral
infection may increase the risk for acute and chronic surgical site
infection.118 119
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\117\ https://www.aaos.org/aaosnow/2011/feb/clinical/clinical2/.
\118\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4919067/.
\119\ https://www.nebh.org/blog/why-its-a-good-idea-to-see-a-dentist-before-your-joint-replacement/ replacement/.
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We acknowledged there is other clinical evidence that does not
support the need for a dental exam and necessary treatment prior to
total joint replacement surgery, specifically total hip and knee
arthroplasty.120 121 Rather, there is evidence that further
study is needed to determine whether pre-operative dental exams and
treatments are necessary and clinically beneficial.\122\ Therefore, we
sought public comment providing systematic clinical evidence as to
whether there is an inextricable link between dental service(s) and
joint replacement surgery such that the dental services are
substantially related and integral to the clinical success of the
surgical procedures. We noted that if we receive compelling clinical
evidence, we may finalize in this final rule additional clinical
scenarios, such as dental services prior to joint replacement surgery
(for example, total hip and knee arthroplasty surgery), where payment
could be made under Medicare Part A or Part B. We sought comment on
whether there is a significant quality-of-care detriment if certain
dental services are not provided prior to joint replacement surgery
(such as total hip and knee arthroplasty surgery), and if so, we
requested a description of that systematic evidence. Specifically, we
requested medical evidence that the provision of certain dental
services leads to improved healing, improved quality of surgery, and
reduced likelihood of readmission and/or surgical revisions, because an
infection has interfered with the integration of the implant and
interfered with the implant to the skeletal structure. We stated that
evidence needed to be clinically meaningful and represent a material
difference that results in some level of persistence in the clinical
success of the procedure to support that pre-operative dental services
are similarly inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services, and therefore, in connection with, and substantially related
and integral to that primary covered medical service. We stated that if
commenters were able to provide us with compelling evidence to support
that a dental exam and necessary treatment prior to joint replacement
procedures such as total hip and knee arthroplasty surgery would result
in clinically significant improvements in quality and safety outcomes,
for example, fewer revisions, fewer readmissions, more rapid healing,
quicker discharge, quicker rehabilitation for the patient, then we
would consider whether such dental services may be inextricably linked
to, and substantially related and integral to the clinical success of,
the joint replacement surgery.
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\120\ Barrere S., Reina N., Peters OA, Rapp L., Vergnes JN,
Maret D. Dental assessment prior to orthopedic surgery: A systematic
review. Orthop Traumatol Surg Res. 2019 Jun;105(4):761-772. doi:
10.1016/j.otsr.2019.02.024. Epub 2019 May 3. PMID: 31060914.
\121\ Young, H., Hirsh, J., Hammerberg, E.M., & Price, C.S.
(2014). Dental disease and periprosthetic joint infection. The
Journal of bone and joint surgery. American volume, 96(2), 162-168.
https://doi.org/10.2106/JBJS.L.01379.
\122\ https://www.sciencedirect.com/science/article/pii/S1877056819301318.
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We also noted that we believe there may be other clinical scenarios
[[Page 69669]]
involving dental services that we have not yet considered, where
certain dental services may be similarly inextricably linked to, and
substantially related and integral to the clinical success of, certain
otherwise covered medical service such that the exclusion under section
1862(a)12) of the Act would not apply. For example, we proposed to
codify current policy that Medicare payment can be made for the wiring
of teeth when done in connection with the reduction of a jaw fracture.
We requested comment on whether there are other dental services
associated with stabilizing and/or repairing the jaw after accidental
injury or trauma and similarly that similarly would not be subject to
the exclusion under section 1862(a)(12) of the Act, and for which we
should consider providing Medicare payment.
We solicited comment on our current approach to payment for dental
services that we have already identified under our current and proposed
policies as inextricably linked to, and substantially related and
integral to the clinical success of, certain covered services, as well
as those services we may yet identify, and other operational topics we
should consider further. We acknowledged that there may be other
clinical circumstances we have not yet identified where dental services
may not be in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, and
instead are similarly inextricably linked to, and substantially related
and integral to the clinical success of, certain other covered medical
services. There may be other clinical scenarios involving physiologic
or anatomic conditions in which dental services could be a medically
critical precondition to the clinical success of other services, such
as certain surgical procedures or cancer treatments. For these reasons,
we solicited comment on whether there are other clinical scenarios for
medical or surgical services where the standard of care is such that
the performance of certain dental services (for example, an exam, and
certain diagnostic and treatment services) is considered to be a
critical clinical precondition to proceeding with the primary medical
procedure and/or treatment, and therefore, may be similarly
inextricably linked to, and substantially related and integral to the
clinical success of, a certain covered service, and therefore, not
subject to the exclusion under section 1862(a)(12) of the Act. We
discussed in the proposed rule that if we were to finalize the proposed
policies as discussed under sections II.L.2.a. and II.L.2.b. of the
proposed rule, we may consider finalizing, based on our review of
public comments, these additional examples of dental services that may
not be subject to the payment exclusion under section 1862(a)(12) of
the Act because they are similarly inextricably linked to, and
substantially related and integral to the clinical success of, covered
medical services. We also noted that if we were to finalize such
additional examples of dental services, we would list those services as
examples under the regulation at Sec. 411.15(i)(3), as discussed in
section II.L.2.c. of the proposed rule. Lastly, as discussed above, we
stated that we recognize that the dental services we have identified
for which Medicare payment could be made under our proposed policies
would occur either prior to, or contemporaneously with, the covered
medical service. We also solicited comments on whether, on the same
basis, there are clinical circumstances under which Medicare payment
could be made for dental services furnished after the covered medical
procedure or treatment.
ii. Establishment of a Process To Consider Additional Clinical
Scenarios for Future Updates
As discussed, we stated that we believe that there may be clinical
scenarios where dental services are not in connection with the care,
treatment, filling, removal, or replacement of teeth or structures
directly supporting teeth, and instead are inextricably linked to, and
substantially related and integral to the clinical success of, certain
covered medical services. We also stated that we believe there may be
additional clinical scenarios we have not yet identified under which
Medicare payment could be made for certain dental services on this
basis. To ensure we are appropriately considering other potential
clinical scenarios that may involve such dental services, we discussed
that we believe it may be appropriate to establish a process whereby
interested parties can share recommendations for our consideration,
review, and analysis for potential inclusion on the list of dental
services for which payment can be made under Sec. 411.15(i)(3) through
future rulemaking. If an interested party believes that there is a
clinical scenario in which certain dental services are similarly
inextricably linked to, and substantially related and integral to the
clinical success of, certain covered medical services, we invited
interested parties to submit information about the clinical scenario
and the medical evidence to support that the standard of care for the
medical service is such that one would not proceed with the medical
procedure or service without performing the dental services, because
the covered medical services would or could be significantly and
materially compromised, or where dental services are a clinical
prerequisite to proceeding with the primary medical procedure and/or
treatment. We described that the interested party should explain why
the particular dental services should not be subject to the general
preclusion on payment for dental services under section 1862(a)(12) of
the Act, because they are inextricably linked to, and substantially
related and integral to the clinical success of, covered medical
services, and provide the medical evidence to support that conclusion.
To ensure that a thorough review can occur, we encouraged
interested parties to include relevant medical literature, clinical
guidelines or generally accepted standards of care, and other
supporting documentation to support our review and consideration of the
clinical scenario involving dental services. To facilitate our
consideration of interested parties' recommendations within an annual
rulemaking cycle, we requested that interested parties submit this
information by February 10th of that year at
[email protected]. Submissions received outside
of the public comment period for a PFS proposed rule would be
considered for possible inclusion in future notice and comment
rulemaking cycles. Recommendations received by February, 10th of a
calendar year would be reviewed for consideration and potential
inclusion within the PFS proposed rule for the subsequent calendar
year. For example, information received by February 10, 2024, would be
reviewed for consideration and potential inclusion within the CY 2025
PFS proposed rule. We encouraged interested parties to engage with us
and provide medical evidence to support their recommendations for
additional clinical scenarios where dental services may not fall within
the scope of the payment preclusion under section 1862(a)(12) of the
Act.
As discussed previously, we stated that we may consider finalizing
a change, after reviewing public comments, in the CY 2023 PFS final
rule to revise the list of examples of dental services for which
Medicare payment can be made. Furthermore, we solicited feedback on:
(1) whether there are additional clinical circumstances we should
consider where dental services are inextricably linked to, and
substantially related and integral to the clinical success of, covered
medical
[[Page 69670]]
services; and (2) the establishment of a process to review additional
clinical scenarios identified by the public, which we may consider
finalizing, after review of public comments received, in this final
rule.
iii. Request for Comment on Dental Services Integral to Covered Medical
Services Which Can Result in Improved Patient Outcomes
As described in section II.L.2 of the proposed rule, we stated that
we believe there are clinical scenarios where the standard of care is
such that there is an immediate need for certain dental services as the
necessary clinical prerequisite to an otherwise covered medical
service. We stated that we believe there may be other clinical
scenarios, however, where the ongoing disease management of the patient
receiving the medically necessary procedure may have an improved
outcome or see a clinical benefit from the performance of dental
services, but that the dental service may not be inextricably linked
to, or substantially related and integral to the clinical success of,
the otherwise covered medical service.
For example, we believe there may be certain circumstances where
the clinical benefit of medical care or treatment of a diabetic patient
could be improved if certain dental services are furnished. We
solicited public feedback on whether certain dental services (for
example, a dental exam, necessary treatment of a dental condition such
as the extraction of an infected and mobile tooth) should be considered
so integral to the standard of care for an otherwise covered medical
service that the preclusion on Medicare payment under section
1862(a)(12) of the Act does not apply.
Additionally, we solicited comments on whether the success of a
given surgery is dependent upon eradication of dental or oral
infection. As noted in section II.L.2.c. of the proposed rule, we
stated that we believe surgeries dealing with organ transplants,
cardiac valve replacement, or valvuloplasty procedures may require a
dental exam and treatment prior to the surgery because the services to
identify and eradicate dental or oral infection are inextricably linked
to, and substantially related and integral to the success of, these
otherwise covered medical services. However, we solicited feedback on
whether there are other types of surgery for which certain dental
services would meet this threshold. We invited public comment on
whether there are other clinical scenarios involving acute or chronic
conditions that would have an improved patient outcome if dental
services are furnished, and if so, whether we should consider these
services as inextricably linked to, and substantially related and
integral to the clinical success of, certain covered medical services.
3. Request for Comment on Other Potentially Impacted Policies
As discussed in section II.L.2.a-b of the proposed rule, we
proposed to codify and clarify our current payment policies for dental
services. We recognized that under these policies there may be
instances where multiple health care providers may need to coordinate
the performance of certain medical and dental services based on the
patients' chronic conditions and/or serious illnesses. We noted that we
continue to consider improvements to our payment policies for care
management services as health care delivery models evolve. As such, we
sought comment on whether our current policies for care management
services make clear that time spent by physicians or non-physician
practitioners coordinating care with dentists regarding the performance
and outcomes of services as proposed under section II.L.2 of the
proposed rule, may be counted for purposes of applicable care
management codes. We also solicited feedback on whether existing care
management codes adequately describe and account for time spent
coordinating with dentists and their clinical staff. We sought comments
regarding the impact of changes in how health care is delivered, and
whether an increased integration and coordination of care among health
care providers should also be taken into account in considering dental
services that may be inextricably linked to, and substantially related
and integral to the clinical success of, a primary medical service.
Additionally, we sought comment as to whether, and to what extent, the
proposed policies as described in section II.L.2 of the proposed rule
would address any inequitable distribution of dental services for
Medicare beneficiaries.
Finally, we recognized that many Medicare beneficiaries have
separate or supplemental dental coverage, such as through a Medigap
plan or other plan offering. We noted that if we were to finalize in
the CY 2023 PFS final rule our proposed policies as described further
in section II.L.2 of the proposed rule, we sought comment on how
current coordination of dental benefits operates, and where
improvements could be provided. Additionally, we sought comment on what
aspects of coordinating benefits among supplemental dental providers we
should consider if we were to finalize the proposed policies as
specified under section II.L.2 of the proposed rule.
4. Request for Comment on Potential Future Payment Models for Dental
and Oral Health Care Services
Our authority under section 1115A(d)(1) of the Act provides broad
authority for the Secretary to waive such requirements of title XVIII
of the Act, which pertain to Medicare, as may be necessary solely for
purposes of carrying out section 1115A of the Act with respect to
testing models described in section 1115A(b) of the Act.
In 2014, the Health Care Innovation Awards (HCIA) Round 2, a
limited time grant initiative, included awards with the goal to improve
the health of populations through activities focused on engaging
beneficiaries, prevention, wellness, and comprehensive care that
extended beyond the clinical service delivery setting. Several
participants used their HCIA Round 2 funds to test models of clinical
care that included payment for dental and oral care services. For
further information regarding the success of these awards as applied to
dental and oral care services please review the HCIA Round 2 Final
Awardee Evaluation Report (2014-2018).\123\
---------------------------------------------------------------------------
\123\ https://innovation.cms.gov/data-and-reports/2020/hcia2-fg-finalevalrpt.
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We sought comment on additional ways to integrate the payment for
dental and oral health care services within existing and future payment
models using the Innovation Center's waiver authority in existing or
future service delivery models, including models focused on equity,
care coordination, total cost of care and specific disease condition.
Summary of Finalized Policies
As described further in the following sections, we are finalizing
effective for CY 2023 (1) a clarification our interpretation of section
1862(a)(12) of the Act and codification of certain of our current
Medicare FFS payment policies for medically necessary dental services;
(2) Medicare Parts A and B payment for dental services, such as dental
examinations, including necessary treatment, performed as part of a
comprehensive workup prior to organ transplant surgery, or prior to
cardiac valve replacement or valvuloplasty procedures effective CY
2023; (3) For CY 2024, we are finalizing Medicare Parts A and B payment
for dental services, such as dental
[[Page 69671]]
examinations, including necessary treatments, performed as part of a
comprehensive workup prior to the treatment for head and neck cancers,
which we indicated we may consider finalizing based on comments
received on the proposed rule; and (4) Effective CY 2023, the
establishment of a process to identify for our consideration and review
submissions of additional dental services that are inextricably linked
and substantially related and integral to the clinical success of other
covered medical services, which we indicated we may consider finalizing
in this final rule.
We are also finalizing amendments to our regulation at Sec.
411.15(i) to provide that dental services that are inextricably linked
to, and substantially related and integral to the clinical success of,
a certain covered medical service(s) are not subject to the exclusion
under section 1862(a)(12) of the Act; and that payment can be made
under Medicare Parts A and B, under the applicable payment system, for
such dental services that occur within the inpatient hospital and
outpatient setting, as clinically appropriate. We are also finalizing,
with modifications, an amendment to Sec. 411.15(i) to include examples
of services that are not subject to the exclusion under section
1862(a)(12) of the Act and for which payment can be made under Medicare
Parts A and B.
The policies we are finalizing take into account commenters'
feedback and information provided in clinical literature, such as peer
reviewed publications or clinical guidelines supported by clinical
evidence, supporting the inextricable link between dental services and
certain covered medical services. First, commenters supported our
interpretation of section 1862(a)(12) of the Act that there may be
instances where medical services necessary to diagnose and treat the
individual's underlying medical condition and clinical status may
require the performance of certain dental services. Second, many
commenters provided recommendations that CMS collaborate with
interested parties to allow for more time to explore the link between
medical and dental services, refine the policy, and respond to many of
the operational and implementation questions raised. We believe that
the process we are finalizing, as described in section II.L.2.c.ii, to
engage with interested parties and review their recommendations
regarding the inextricable link between dental services and certain
covered medical services will serve the need expressed by commenters
for continued engagement on these issues. We are also finalizing for CY
2024, Medicare payment under Parts A and B for dental services prior to
treatment for head and neck cancers, as an additional example of dental
services that are inextricably linked to certain covered medical
services than was presented in the proposed rule. This will allow us to
continue to further consider definitional issues over the coming year.
Additionally, we intend to continue to engage in discussions with the
public on a wide spectrum of issues relating to Medicare payment for
certain dental services that do not fall within the preclusion or
exclusion under section 1862(a)(12) of the Act and related topics.
Furthermore, we remain open to adjusting our finalized policy through
future rulemaking and/or additional guidance as necessary. We
appreciate the thoughtful questions raised by commenters and are
committed to continued engagement.
We are not finalizing, at this time, payment for dental services
prior to the initiation of immunosuppressant therapy, joint replacement
surgeries, or other surgical procedures, which we had indicated in the
CY 2023 PFS proposed rule that we may finalize in this final rule. As
further described below, we agree with the feedback received from many
commenters that additional time is necessary to consider the
inextricable link between dental services and these covered medical
services, and with commenters' requests to develop definitions to guide
decision making. We are committed to continuing to explore the
potential inextricable relationship between dental services and these
covered medical services through the process we proposed, as described
under section II.L.2.c.ii of this final rule, and are finalizing
beginning for CY 2023.
Comments and Responses to the Policies Discussed in the Proposed Rule
In this section, we summarize and respond to public comments on the
policies that we either proposed within the CY 2023 PFS proposed rule
(87 FR 45860, 46033 through 46040) or indicated that we may consider
finalizing within the CY 2023 PFS final rule. Commenters included
individuals, patient advocacy organizations, hospitals and hospital
associations, medical and dental associations representing several
different specialties and specialty societies, and health insurance
companies, among others. We note that some commenters requested that we
consider Medicare coverage policies that were outside the scope of the
policies discussed in the CY 2023 PFS proposed rule. We thank the
commenters and note that we will take these comments into consideration
for the future.
We note that many commenters responded to our request for
information under section II.L.2.c.iii. of this rule to express the
view that payment of dental services could improve patient outcomes and
quality of life and reduce Medicare expenditures overall by avoiding
the need to cover medical complications arising from untreated dental
conditions. Many commenters encouraged CMS to apply its authority to
pay for dental services associated with certain covered medical
services to as broad of a range of clinical scenarios as possible,
including, but not limited to, payment for routine dental care for
patients with (or at risk of developing) medical conditions such as
diabetes, cardiovascular disease, some lung diseases, or physical and
cognitive impairments that impact individuals' ability to perform
activities of daily living (including tooth brushing). Commenters also
encouraged us to consider the provision of dental care in relation to
treatments such as bisphosphonate therapy, substance use disorder
treatment, prescription of certain psychiatric medications, or any
surgery that may result in hospitalization. We thank commenters for
both the personal and clinical information submitted regarding the
importance between dental and oral health, and various medical
conditions and certain medical services. We are still reviewing the
wide array of suggestions, clinical information to elucidate the
connection between dental health and clinical outcomes of many of the
medical services, and other information provided in response to this
request for information. Given these factors, we want to continue to
engage with interested parties and consider this material through the
public process as finalized under section II.L.2.c.ii. of this final
rule or potentially in future rulemaking. Additionally, we encourage
additional public discussions and engagement on a wide range of issues
relating to Medicare payment for certain dental services that do not
fall within the exclusion under section 1862(a)(12) of the Act.
Finally, we thank commenters for their thoughtful feedback on the
requests for information on other potentially impacted policies
(section II.L.3. of this final rule) and potential future payment
models for dental and oral health care services (section II.L.4. of
this final rule). We did not indicate in the CY 2023 PFS proposed rule
that
[[Page 69672]]
we may finalize policies in these areas in the CY 2023 PFS final rule.
We continue to review this feedback and will consider these comments on
other potentially impacted payment policies within the public process
we are finalizing, as described under section II.L.2.c.ii. of this
final rule, and in potential future rulemaking or guidance, as
necessary. We also look forward to ongoing discussions with the public
on issues relating to the provisions described in this rule as well as
dental services that do not fall within the exclusion under section
1862(a)(12) of the Act.
Payment for Inpatient Hospital Dental Services and Request for Comment
Comment: Commenters generally expressed support for our
interpretation of the statute and our current regulation to allow
Medicare payment for inpatient hospital services in connection with the
provision of dental services if the individual, because of their
underlying medical condition and clinical status or because of the
severity of the dental procedure, requires hospitalization in
connection with the provision of such services. Some commenters
recommended that CMS undertake a Medicare demonstration for
beneficiaries with underlying medical conditions who require integral
dental services as a condition of their covered primary Medicare Part A
service to determine the financial and operational efficiencies.
Other commenters requested that CMS provide further clarity around
the type of dental services, medical conditions and services, and
patient clinical statuses that would allow for Medicare payment in this
manner. Commenters also requested that CMS further define whether the
types of underlying medical conditions include hospitalizations for
mental health or substance use disorders.
Response: We appreciate the commenters' support for our proposal to
clarify and codify our current policy to allow Medicare payment to be
made for inpatient hospital services in connection with the provision
of dental services, if the individual, because of their underlying
medical condition and clinical status or because of the severity of the
dental procedure, requires hospitalization in connection with the
provision of such services. We appreciate the requests made by
commenters for additional guidance to promote consistent application of
the policy. We also believe that the codification and clarification of
our current policy will assist in fostering consistent national
application of this policy. We intend to provide additional guidance to
CMS Medicare Administrative Contractors (MACs) and the public as needed
to facilitate further consistent application of this policy.
Clarifying the Interpretation of Section 1862(a)(12) of the Act and
Codifying Current Payment Policies for Certain Dental Services
Comment: Many commenters supported our proposal to interpret
section 1862(a)(12) of the Act to permit Medicare payment under Parts A
and B for dental services, where the dental service is inextricably
linked to, and substantially related and integral to the clinical
success of, certain other covered medical services. These commenters
supported our proposal to allow payment to be made because they agreed
that the service is not in connection with the care, treatment,
filling, removal, or replacement of the teeth or structures supporting
the teeth, but instead is inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services. The majority of commenters also supported our
proposal to clarify in regulation that payment for dental services that
do not fall within the scope of section 1862(a)(12) of the Act because
they are inextricably linked to, and substantially related and integral
to the clinical success of, certain other covered medical services,
could be made regardless of whether the services are furnished on an
inpatient or outpatient basis. These commenters encouraged CMS to apply
this policy in all clinical circumstances where appropriate. Some
commenters suggested that such outpatient dental services might be
provided through mobile clinics, via teledentistry, and in congregate
care settings such as nursing facilities, assisted living facilities,
etc.
One commenter questioned whether current hospital billing
requirements would influence whether patients needing dental services
will be admitted on an inpatient basis or treated as on an outpatient
basis, and whether that would affect how much beneficiaries pay for
these services.
Other commenters suggested that our proposal was focused too
narrowly, and suggested broader interpretations of 1862(a)(12). One
commenter suggested that oral care services (such as examinations;
biopsies; radiological studies; other tests; and treatments of growths
and lesions, benign or malignant, of the cheeks, lips, and tongue) are
distinct from, and therefore not excluded from Medicare payment as
dental services in connection with the care, treatment, filling,
removal, or replacement of teeth or structures directly supporting
teeth. Similarly, another commenter suggested that the Medicare statute
excludes coverage and payment only for those dental services performed
primarily for the purpose of treatment of the teeth or structures
directly supporting the teeth, and therefore all other dental services
performed to support another Medicare-covered procedure would be
eligible for payment.
Response: We appreciate commenters' support for our proposal to
permit Medicare payment under Parts A and B for dental services, where
the dental service is inextricably linked to, and substantially related
and integral to the clinical success of, certain other covered medical
services; and to allow payment to be made regardless of whether the
services are furnished in an inpatient or outpatient setting. As such,
we are finalizing our proposal to codify and clarify in the regulation
at Sec. 411.15(i) that payment can be made under Medicare Parts A and
B for dental services that are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services; and that payment will be allowed for
services furnished in inpatient and outpatient settings (where
clinically appropriate) with payment being made for covered services
under the applicable payment system. We appreciate the concerns raised
by commenters regarding our interpretation of section 1862(a)(12) of
the Act. However, we believe that section 1862(a)(12) allows for
payment in this manner because such dental services are not in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth within the meaning of
section 1862(a)(12) of the Act. Instead, we believe they are
inextricably linked to the clinical success of an otherwise covered
medical service, and therefore, are substantially related and integral
to that primary medical service. We appreciate commenters' request for
guidance on this policy and will work to provide additional guidance,
as needed, to promote consistent application of this policy. We expect
such guidance may also reinforce and clarify that medical care
involving the mouth, not in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting teeth, is not subject to exclusion under section 1862(a)(12)
of the Act, that CMS MACs may make claim-by-claim determinations, as
necessary.
[[Page 69673]]
Comment: Some commenters recommended that we limit the scope of
Medicare payments for oral examinations prior to certain covered
medical services. These commenters stated that Medicare should continue
to make payment for oral examinations under Medicare Part A if
performed by a dentist on a hospital's staff; however, Medicare Part B
should only make payment for oral examinations performed by a
physician, excluding dentists. These commenters requested that CMS not
clarify in regulation that the statutory definition of physician under
section 1861(r)(2) of the Act applies in these circumstances, and
instead requested that CMS maintain, as stated in the NCD Manual (IOM
Pub 100-03, Chapter 1, Part 4, section 260.6), that when performing a
dental or oral examination, a dentist is not recognized as a physician
under section 1861(r) of the Act. These commenters stated that
physicians should be the leaders of the patient care team and that
diagnosis of the medical issue, and subsequent care plan, should be
determined only by the medical professional, not the dentist. Other
commenters asked whether medical professionals could perform the dental
exams in accordance with current policy. These commenters further
requested clarification as to whether we would apply equivalent
physician administrative (such as electronic health record reporting
and merit-based incentive payments), enrollment, and compliance
requirements to dentists as are applied to other physician
professionals under Medicare Part B.
Response: We appreciate commenters' questions regarding our
proposal to provide Medicare payment for oral or dental examinations
performed as part of a comprehensive workup prior to certain covered
medical services, and acknowledge their request to narrow the scope of
the proposal. However, we continue to believe that the current language
in the NCD manual is based on an unnecessarily narrow reading of
section 1861(r) of the Act, and is not consistent with other manual
provisions. We believe the statutory definition of physician under
section 1861(r) of the Act is clear in its inclusion of a doctor of
dental surgery or of dental medicine, and a similar definition of
physician is included in our Medicare General Information, Eligibility,
and Entitlement Manual (IOM Pub 100-1, Chapter 5, section 70.2) when
dental or oral examinations, and specific treatments, are within the
State scope of practice for the dentist.
We thank commenters for their request for clarification of the
medical professionals' (physician or non-physician practitioner) role
within the performance of dental services that are inextricably linked
to the clinical success of certain covered medical services. We agree
that involvement and integration between medical and dental
professionals is an important component of the delivery of these
medical services, and is fundamental to our policy permitting payment
for certain dental services under Medicare Parts A and B. Further, we
appreciate the commenters' point, and also believe that physician and
non-physician practitioner engagement in the patient's care team is
important. As such, Medicare Parts A and B payment for dental services
not in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth within the
meaning of section 1862(a)(12) of the Act can occur only when dental
and medical services are integrated and when the dental services are
inextricably linked to certain covered medical services. Without both
integration between the medical and dental professional, and the
inextricable link between the dental and covered medical services such
that the dental services are integral to the clinical success of the
medical services, Medicare payment for the services would be precluded
under Medicare Part B and therefore section 1862(a)(12) of the Act. We
note that dental services that are precluded from payment under Part B
under the statutory payment exclusion in section 1862(a)(12) of the Act
may be eligible to be covered and paid by supplemental dental plans.
We believe integration between medical and dental professionals can
occur when these professionals coordinate care. This level of
coordination can occur in various forms such as, but not limited, to a
referral or exchange of information between the medical professional
(physician or non-physician practitioner) and the dentist. This
coordination should occur between a dentist and another medical
professional (physician or other non-physician practitioner) regardless
of whether both individuals are affiliated with or employed by the same
entity. We note that to be eligible to bill and receive direct payment
for professional services under Medicare Part B, the medical
professional and dentist would need to be enrolled in Medicare and meet
all other requirements for billing under the PFS. (Alternatively, a
dentist not enrolled in Medicare could perform services incident-to the
professional services of a Medicare enrolled physician. In that case,
the services would need to meet the requirements for incident-to
services under Sec. 410.26, including the appropriate level of
supervision. Payment would be made to the enrolled physician who would
bill for the services.) Furthermore, the state scope of practice for
the medical and dental professional must support the professional
performing the specific dental service(s). If there is no exchange of
information between the medical professional (physician or other non-
physician practitioner) and the dental professional, then we do not
believe there can be an inextricable link between the dental and
covered medical service for purposes of Medicare payment for the dental
services within the meaning of section 1862(a)(12) of the Act. This is
because the medical and dental professionals would not have the
necessary information to decide that the dental service is inextricably
linked to a covered medical service, and therefore, not subject to a
statutory payment exclusion under section 1862(a)(12) of the Act.
In regard to commenters' request for clarification as to whether
equivalent administrative, enrollment, and compliance requirements
would apply to dentists as are applied to other physicians,
practitioners, and healthcare professionals under Medicare Part B, we
note that dentists are included in the statutory definition of
physician at section 1861(r)(2) of the Act, and would generally be
considered and treated as a physician for purposes of enrollment,
compliance, and other administrative programs including the Merit-Based
Incentive Payment Systems (MIPS) (for more information about MIPS
eligibility please see: https://qpp.cms.gov/mips/how-eligibility-is-determined), which includes requirements related to electronic health
record (EHR) usage for physicians, and is applicable to eligible
professionals as defined in section 1848(k)(3)(B) of the Act. Because
``a physician'' is specified as an eligible professional under this
definition, and a doctor of dental surgery or dental medicine is
included in the definition of physician in section 1861(r) of the Act,
the MIPS reporting requirements would apply to dentists who are
determined to MIPS eligible clinicians.
We appreciate the concerns raised by commenters and will work to
provide additional guidance to answer enrollment, billing, compliance,
and other administrative questions for dentists as needed.
Comment: Commenters generally supported our proposal to codify
examples of dental services for which payment is permitted under our
current
[[Page 69674]]
policy: (1) dental or oral examination as part of a comprehensive
workup prior to a renal organ transplant surgery; (2) reconstruction of
a dental ridge performed as a result of and at the same time as the
surgical removal of a tumor; (3) wiring or immobilization of teeth in
connection with the reduction of a jaw fracture; (4) extraction of
teeth to prepare the jaw for radiation treatment of neoplastic disease;
and (5) dental splints only when used in conjunction with medically
necessary treatment of a medical condition. One commenter suggested
that the term ``wiring of the teeth'' be instead identified as
``stabilization of teeth'' to align with current medical terminology.
Another commenter noted that ``wiring'' and ``splinting'' are commonly
used and accepted terms, and that they are sometimes used
interchangeably, along with ``stabilization.'' The same commenter
requested clarification as to the rationale for including, ``dental
splints only when used in conjunction with covered treatment of a
medical condition such as dislocated jaw joints'' in proposed Sec.
411.15(i)(3)(i)(E) as well as ``wiring or immobilization of teeth in
connection with the reduction of a jaw fracture'' in proposed Sec.
411.15(i)(3)(i)(C) and suggested that the two related paragraphs be
combined.
Response: We appreciate commenters' support for our proposal to
codify examples of dental services for which payment is permitted under
our current policy. We thank commenters for suggesting updates in
medical terminology. We agree that the dental services examples
provided under current policy: (1) dental or oral examination as part
of a comprehensive workup prior to a renal organ transplant surgery;
(2) reconstruction of a dental ridge performed as a result of and at
the same time as the surgical removal of a tumor; (3) wiring or
immobilization of teeth in connection with the reduction of a jaw
fracture; (4) extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease; and (5) dental splints only when used
in conjunction with medically necessary treatment of a medical
condition, are examples of dental services that are inextricably linked
to, and substantially related and integral to the clinical success of,
certain other covered medical services, and therefore, continue to
believe that Medicare Parts A and B payment could be made for them.
As such, we are finalizing our proposal to amend Sec. 411.15(i) to
clarify that: (1) dental or oral examination as part of a comprehensive
workup prior to a renal organ transplant surgery (and as discussed in
detail below, we are expanding this to include all organ transplant
surgeries); (2) reconstruction of a dental ridge performed as a result
of and at the same time as the surgical removal of a tumor; and (3)
extraction of teeth to prepare the jaw for radiation treatment of
neoplastic disease, are examples of dental services that are
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services, and
therefore, and continue to believe that Medicare Parts A and B payment
could be made for them.
We were persuaded by the information provided by commenters
regarding the medical terminology we use at Sec. 411.15(i)(3)(C), the
suggestion to replace ``wiring or immobilization of the teeth'' with
``stabilization,'' and also the suggestion to combine two related
paragraphs, Sec. Sec. 411.15(i)(3)(C) and 411.415(i)(3)(E). In
response to comments, we are finalizing a revision to Sec. 411.15(i)
to merge the two related paragraphs into one paragraph at Sec.
411.15(i)(3)(C). The revised paragraph will refer to, ``The
stabilization or immobilization of teeth in connection with the
reduction of a jaw fracture and dental splints only when used in
conjunction with covered treatment of a covered medical condition, such
as dislocated jaw joints.''
Comment: Several commenters expressed support for our proposal to
provide that payment can be made for ancillary services and supplies
furnished incident to covered dental services, including but not
limited to x-rays, administration of anesthesia, and use of the
operating room. Several commenters recommended removal of any
requirements for direct supervision of auxiliary personnel, such as for
services performed by dental hygienists, for ancillary services and
supplies furnished incident to covered dental services, because they
stated the physical presence of the dentist could limit access to
services. These commenters stated that requiring direct supervision of
dental hygienists would also be in conflict with some state's scope of
practice for these auxiliary personnel. Other commenters requested that
certified registered nurse anesthetists (CRNAs) continue to be
recognized as anesthesia professionals able to administer anesthesia in
these circumstances and receive Medicare payment.
Response: We appreciate commenters' support for our proposal to
provide that Medicare payment can be made for ancillary services and
other supplies furnished incident to covered dental services, such
ancillary services including but not limited to x-rays, administration
of anesthesia, and use of the operating room. We note that we did not
propose to modify our current policies with respect to the scope of
professional services, or the administration of anesthesia services, by
CRNAs.
In order for physicians and other practitioners, including
dentists, to receive Medicare Part B payment for services that are
performed by auxiliary personnel incident to their professional
services, the services generally must be performed under the direct
supervision of the physician or practitioner. This is one of the
requirements specified in our regulation at Sec. 410.26 for ``incident
to'' services, such as services performed by dental hygienists and
billed by the dentist incident to their professional services. We note
that the definition of direct supervision does not require the
physician or dentist to be physically present within the room during
the performance of the dental services. We did not propose to modify
our regulatory requirements under Sec. 410.26 for services furnished
incident to physicians' services. Therefore, those regulatory
requirements continue to apply. We will consider the commenters'
recommendations for adjusting the supervision requirements of auxiliary
personnel, including dental hygienists, performing covered dental
services incident to dental services of a physician for potential
future rulemaking.
Update to Current Payment Policies for Dental Services
Comment: Many commenters supported the proposed updates to include
payment for medically necessary dental services related to additional
conditions (prior to organ transplant, cardiac valve replacement, or
valvuloplasty procedures), stating that dental services in these
circumstances are inextricably linked to the proposed medical services,
are medically necessary, and providing payment for them will foster and
improve patient outcomes related to these medical conditions.
Response: We appreciate the commenters' support and agree that the
payment policy updates we proposed represent examples of dental
services that are inextricably linked to, and substantially related and
integral to the clinical success of, covered medical services. As
discussed, these examples include payment for dental services prior to
organ transplant, cardiac valve replacement, or valvuloplasty
procedures. As such, we are finalizing
[[Page 69675]]
our proposal that Medicare Part A and Part B payment can be made for
dental or oral examinations, including necessary treatment, performed
as part of a comprehensive workup prior to organ transplant surgery, or
prior to cardiac valve replacement or valvuloplasty procedures, that
are inextricably linked to, and substantially related and integral to
the clinical success of, these covered medical services.
Comment: Many commenters expressed support for the proposed update
for payment for medically necessary dental services related and
integral to the clinical success of organ transplants, cardiac valve
replacement or valvuloplasty procedures, as the commenters believe that
these revisions would serve to promote health equity and increase
access to medically necessary services for vulnerable members of the
Medicare population. The commenters asserted that underserved
populations generally do not have access to the necessary oral health
services required for successful outcomes related to organ
transplantation and cardiac valve replacement or valvuloplasty
procedures.
Response: We appreciate the commenters' support regarding the
potential health equity impact of the proposed updates to the current
policy for payment under Medicare Parts A and B for dental services
that are inextricably linked to, and substantially related and integral
to the clinical success of, covered medical services to now include
organ transplant, cardiac valve replacement, or valvuloplasty
procedures. We further appreciate the feedback that Medicare payment
for dental examinations, including necessary treatment, performed as
part of a comprehensive workup prior to organ transplant surgery, or
prior to cardiac valve replacement or valvuloplasty procedures could
help advance health equity for people who are medically underserved.
Comment: Many commenters expressed support for the proposal to
include Medicare Parts A and B payment for dental examination, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection, prior to an organ transplant. Commenters
indicated that it is standard practice for candidates for organ
transplants to require a dental assessment and/or screening for, and
treatment of, decay and infections including periodontal disease before
transplant surgery, as these conditions potentially compromise the
outcomes of surgery including organ rejection. Commenters noted a wide
variation of terms and clinical scenarios where certain dental services
may be necessary for certain patients surrounding a transplantation
procedure, and requested CMS further delineate specific circumstances
where payment may be made under Medicare Parts A and B.
Commenters stressed the importance of remedial oral or dental care
in advance of transplantation to reduce dental and oral infection and
stated that the resolution or stabilization of dental problems prior to
transplant procedures lowers the risk for infection and sepsis post-
transplant. Several of these commenters provided citations from opinion
pieces to support their perspectives. Some commenters noted that,
according to the National Institute of Dental and Craniofacial
Research, ``Whenever possible, all active dental disease should be
aggressively treated before transplantation, since post-operative
immunosuppression decreases a patient's ability to resist systemic
infection.'' We note that the authors further stated that, ``there was
an association between dental focus and hospital readmission/stay.
However, our methods do not provide conclusive proof of causality.
Hospitalization due to acute dental infection was rare.'' \124\
---------------------------------------------------------------------------
\124\ National Institute of Dental and Craniofacial Research.
April 2011. Dental Management of the Organ Transplant Patient.
https://www.in.gov/health/files/OrganTransplantProf.pdf.
---------------------------------------------------------------------------
Commenters also asserted that inflammation combined with required
immune suppression for transplant procedures can yield poor outcomes
post-transplantation and that high rates of poor oral health, including
periodontal disease and xerostomia, are risk factors for compromising
successful transplant outcomes. Moreover, a few commenters noted that
patients are generally required to demonstrate good oral hygiene to
even be considered active on the organ transplant waiting list.
Commenters also stated that they believe dental services that are
substantially related and integral to the clinical success of
transplants need to be provided to candidates before any such
procedure, regardless of whether transplantation ultimately occurs.
Commenters noted that the elimination of oral or dental infection is
necessary prior to surgery, even if the procedure does not take place.
Commenters also noted that medically necessary services may be required
during the transplantation procedure, as some oral issues may not be
identified until the procedure is underway.
Moreover, commenters expressed concerns that some patients who may
be awaiting transplantation services could receive dental services and
then undergo the transplantation procedure only to experience organ
rejection, other non-ideal outcomes, or ultimately not receive
transplantation procedure due to extenuating circumstances. The
commenters were concerned that while the dental services are
substantially related and integral to the clinical success of the
planned or furnished covered transplantation services, in the event the
transplant procedure is ultimately not successful due to rejection or
the procedure does not occur for various medical reasons, Medicare
could deny payment for the dental care that is substantially related
and integral to the organ transplant because the transplant surgery was
not completed or unsuccessful.
Commenters explained that life-threatening infections related to
the weakened immune systems of older adults (immunosenescence) and
transplant-related immunosuppression can be serious complications of
transplantation after the transplantation occurs. These commenters also
stated that transplant patients typically take multiple medications
involving long-term use of immunosuppressive drugs, as well as multiple
medications for co-morbidities like diabetes and cardiovascular
disease, and that dental services may be required in addressing these
post-transplantation conditions.
Several commenters requested that CMS provide payment under
Medicare Parts A and Part B for medically necessary diagnostic and
treatment services after an organ transplant, rather than only before
or during the transplant procedure because they stated that dental
services both before and after the transplantation procedure itself
influence the outcome of the transplant. A commenter stated that
screening for and treatment of oral inflammation and infections must
begin pre-transplantation and continue as appropriate post-
transplantation, for a duration of approximately 3 to 6 months, in
order to prevent sepsis and organ rejection until immunosuppression is
resolved. Other commenters supported Medicare payment for dental
services that occur post-transplant by asserting the importance of
post-transplant oral care to clinical outcomes. Lastly, these
commenters requested that CMS reconsider the statement asserting that
no payment would be made for services that are not immediately
necessary prior to surgery to eliminate or eradicate infection.
[[Page 69676]]
Response: We appreciate the commenters' thoughtful and evidence-
based feedback regarding the link between oral or dental examinations,
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection, and organ transplants.
We agree with commenters that there is clinical evidence to support
that the medically necessary dental care may advance the clinical
success of organ transplants. We appreciate the clinical studies
referenced to support the link between dental services prior to organ
transplantation and improved health outcomes for certain patients.
Therefore, we believe that payment can be made under Medicare Parts A
and B for dental services such as dental examinations, including
necessary treatment, performed as part of a comprehensive workup prior
to organ transplant surgery and medically necessary diagnostic and
treatment services immediately necessary to eliminate or eradicate the
infection or its source that are provided before transplantation
because such services are inextricably linked to, and substantially
related and integral to the clinical success of, the organ transplant
procedure.
We also agree that medically necessary dental diagnostic and
treatment services may be immediately necessary to eliminate or
eradicate an infection or its source contemporaneously with the organ
transplant. We understand that it may not be feasible to provide
certain dental or oral services in advance of the transplant procedure
and that the services may instead occur during the surgery itself.
Examples of dental services to eradicate infection could include:
extractions (removal of the entire infection, such as pulling of
teeth--for example, CDT D7140, D7210), restorations (removal of the
infection from tooth/actual structure, such as filling procedures--for
example, CDT D2000-2999), periodontal therapy (removal of the infection
that is surrounding the tooth, such as scaling and root planing--for
example, CDT D4000-4999, more specifically D4341, D4342, D4335 and
D4910), or endodontic therapy (removal of infection from the inside of
the tooth and surrounding structures, such as root canal--for example,
CDT D3000-3999).
Additionally, we note that when dental services, such as dental
examinations, including necessary treatment, are performed as part of a
comprehensive workup prior to organ transplant surgery, and medically
necessary diagnostic and treatment services immediately necessary to
eliminate or eradicate the infection or its source, prior to, or
contemporaneously with, the organ transplant occur, and, ultimately,
the transplantation procedure does not yield ideal clinical outcomes
including organ rejection etc., payment may still be made under
Medicare Part A and Part B for the dental services provided. The dental
services are inextricably linked to, and substantially related and
integral to the clinical success of the transplantation procedure, and
achievement of ideal clinical outcomes (for example, no occurrence of
organ rejection) is not a requirement for the payment of these
medically necessary services.
Furthermore, we appreciate the commenters' feedback regarding those
individuals who are awaiting organ transplantation and the commenters'
request that Medicare provide payment for medically necessary dental
services prior to transplantation, with the understanding that the
transplantation procedure may not ultimately occur, and that payment
should still be made under Medicare Part A and Part B for those
medically necessary dental services.
In a case where an individual is awaiting organ transplantation, we
believe that it is appropriate for Medicare to provide payment for,
including but not limited to, an oral or dental examination, and
medically necessary diagnostic and treatment for only those services
that are considered immediately necessary to eliminate or eradicate the
infection or its source prior to the organ transplant. As previously
discussed in this final rule, when a service is in connection with the
care, treatment, filling, removal, or replacement of the teeth or
structures supporting the teeth, but not inextricably linked to, and
substantially related and integral to the clinical success of, the
covered medical services, then payment may be made but only in specific
circumstances as discussed in section II.L.2.a of this rule. We do not
currently believe that our interpretation of section 1862(a)(12) of the
Act would allow payment for dental services not inextricably linked to,
and substantially related and integral to the clinical success of
anticipated covered medical services. Therefore, payment would not be
made in those circumstances.
We appreciate the commenters' feedback regarding Medicare payment
for medically necessary dental services after the transplantation
procedure occurs. We thank commenters for the evidence they provided to
connect the importance of dental care received after the organ
transplant on the success of that transplant procedure. We received
significant input from commenters in this area and want to thoroughly
review the evidence provided. We plan to continue to review this
evidence and engage with interested parties to issue additional
guidance or future rulemaking, as determined necessary.
With regard to commenters' questions on the types of clinical
scenarios where dental services may be necessary prior to
transplantation procedures, we reiterate that MACs have the flexibility
to determine on a claim-by-claim basis whether a patient's
circumstances do or do not fit within the terms of the preclusion or
exception specified in section 1862(a)(12) of the Act and Sec.
411.15(i). We will provide additional guidance to the MACs in order to
make these determinations and further note that the finalized policies
outlined in this section of this final rule would not prevent a MAC
from making the type of determination that payment can be made for
dental services in other circumstances not specifically addressed
within this final rule and the finalized amendments to Sec. 411.15(i).
In light of commenters' feedback, effective for CY 2023, we are
finalizing that payment can be made under Medicare Part A and Part B
for dental services for, including but not limited to, an oral or
dental examination, and medically necessary diagnostic and treatment
services that are considered immediately necessary to eliminate or
eradicate the infection or its source prior to, or contemporaneously
with, the organ transplant and when those dental services are
determined to be inextricably linked to, and integral to the clinical
success of, the transplant procedure. We plan to continue reviewing
evidence submitted by commenters and may refine or explain this policy
further in future guidance or rulemaking.
We encourage the public to use the nomination process as finalized
in section II.L.2.c.ii. of this final rule to identify additional
clinical scenarios under which Medicare payment could be made for
certain dental services that are similarly inextricably linked to, and
substantially related and integral to the clinical success of, certain
covered medical services. We invite interested parties to submit
information about clinical scenarios and related medical evidence to
support that the standard of care for the medical service is such that
one would not proceed with the medical procedure or service without
performing the dental services, because the covered medical services
would or could be significantly and materially
[[Page 69677]]
compromised, such that clinical outcomes of the medical service could
be compromised absent the provision of the inextricably-linked dental
services.
Comment: Several commenters noted that while they acknowledge the
connection between dental services and potential improved health
outcomes in the cases of the proposed organ transplant, cardiac valve
replacement, and/or valvuloplasty procedure scenarios, they urged CMS
to delay any updates and use a methodical approach to adding further
services as examples of clinical scenarios where Medicare payment could
be made for certain dental services. Several commenters requested that
CMS postpone finalizing the addition of dental exams and necessary
treatments prior to organ transplants, heart valve replacements and
valvuloplasty procedures until the establishment of a formal review
process that could more thoroughly assess the clinical inextricable
link between dental services and certain covered medical services
before finalizing any additional examples of payable services.
One commenter asserted that CMS had provided insufficient
scientific justification for the addition of the organ transplant,
cardiac valve replacement, or valvuloplasty procedure scenarios for the
purposes of Medicare Parts A and B payment for dental services and
therefore did not support the finalization of these additional
scenarios. Additionally, a few commenters asserted that MACs already
have the ability to make case-by-case determinations for dental
services inextricably tied to Medicare Part A procedures, and
therefore, the addition of the proposed categories were not necessary.
Other commenters stated that CMS lacked the statutory authority to
finalize payment for these types of dental services.
Response: We appreciate the commenters' request that we conduct a
thorough review of the clinical evidence related to the proposals. As
discussed, we believe that the clinical evidence is clear that in cases
of organ transplant, cardiac valve replacement, and valvuloplasty
procedures, certain dental services are substantially related and
integral to the clinical success of these scenarios because the success
of the procedure would be compromised without eradicating the dental or
oral infection prior to the initiation of such medical service.
Therefore, we are amending Sec. 411.15(i) to include these clinical
scenarios as examples under which Medicare payment under Part A and
Part B would not be excluded.
Additionally, as described further below, we are finalizing for CY
2024 the inclusion of dental services prior to the treatment for head
and neck cancers as a clinical scenario under which Medicare payment
under Part A and Part B would not be excluded. We are finalizing this
policy for CY 2024 to allow us additional time with the clinical data
and to conduct additional analysis to consider whether greater
specificity may be needed when implementing this policy and the
applicability of certain terms with the medical services involved in
this type of treatment. We reiterate that MACs have the flexibility to
determine on a claim-by-claim basis whether a patient's circumstances
do or do not fit within the terms of the preclusion or exception
specified in section 1862(a)(12) of the Act and Sec. 411.15(i). We
further note that the finalized policies outlined in this section of
this final rule would not prevent a MAC from making the type of
determination that payment can be made for dental services in other
circumstances not specifically addressed within this final rule and the
finalized amendments to Sec. 411.15(i).
We appreciate the request that we continue to review whether there
is an inextricable link between dental and medical services in general
and we will continue to evaluate and review the clinical considerations
submitted by commenters. We may refine or explain this policy further
through future guidance or rulemaking. We also note that we are
finalizing a process to review public recommendations for clinical
scenarios where there may be an inextricable link between certain
dental services and covered medical services, and encourage commenters
to engage with us through the process we are finalizing in this final
rule.
With regard to the commenter who stated we did not have statutory
authority to finalize a policy in this area, we continue to recognize
that there may be instances where medical services necessary to
diagnose and treat the individual's underlying medical condition and
clinical status may require the performance of certain dental services.
Furthermore, we believe that there are instances where dental services
are so integral to other medically necessary services that they are not
in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth within the
meaning of section 1862(a)(12) of the Act. Rather, we continue to
believe, based on the review of comments, such dental services are
inextricably linked to the clinical success of an otherwise covered
medical service, and therefore, are instead substantially related and
integral to that primary medical service.
Comment: Several commenters requested clarification regarding the
definition of organ transplant as it applies to Medicare payment for
dental services that are substantially related and integral to the
clinical success of certain covered medical services. Specifically,
they requested that the definition include not only organ transplants,
but also hematopoietic stem cell and other transplants.
Commenters stated that dental examination and stabilization,
specifically resolution of concerns related to oral health, are
considered a standard of care in hematopoietic stem cell transplants
(HSCT) since any patients who are on immunosuppressant therapies while
receiving chemotherapy and radiation receive a clinical benefit from
dental or oral stabilization care pre-transplant and continued care
post-transplant,\125\ which the commenters assert represents the
majority of the HSCT patient population.
---------------------------------------------------------------------------
\125\ 2 Elad, S., Raber-Durlacher, J.E., Brennan, M.T. et al.,
Basic oral care for hematology-oncology patients and hematopoietic
stem cell transplantation recipients: a position paper from the
joint task force of the Multinational Association of Supportive Care
in Cancer/International Society of Oral Oncology (MASCC/ISOO) and
the European Society for Blood and Marrow Transplantation (EBMT).
Support Care Cancer 23, 223-236 (2015). doi.org/10.1007/s00520-014-2378-x.
---------------------------------------------------------------------------
Some of these commenters also noted that bone marrow
transplantation may also require dental services that are inextricably
linked to, and substantially related and integral to the clinical
success of these covered medical services, as commenters asserted that
dental and oral services serve to improve clinical outcomes for these
types of transplants. Additionally, commenters stated that dental
services prior to CAR-T cell therapies may also benefit the patient
receive the medical service.
Response: We appreciate the commenters' feedback regarding the
scope of organ transplant as it applies to Medicare Parts A and B
payment for dental services that are inextricably linked to, and
substantially related and integral to the clinical success of certain
covered medical services. We agree with the evidence commenters
provided regarding the inextricable link between dental services and
hematopoietic stem cell and bone marrow transplantation as consistent
with the other organ transplants, particularly with regard to the risk
of infection for patients requiring all of these organ transplants.
[[Page 69678]]
In response to comments, we are clarifying that Medicare payment
may be made under Parts A and B for dental or oral services prior to
organ transplants, which for the purposes of this policy includes
scenarios where the patient receives an organ transplant, including a
bone marrow or hematopoietic stem cell transplant. We also recognize
that term ``organ transplant'' may not be considered to include bone
marrow or hematopoietic stem cell transplants in all contexts, and note
that Medicare payment policies for organ procurement organizations or
other payment policies may be applied differently for the purposes of
paying for bone marrow and stem cell transplantations.
Comment: Many commenters supported our proposal to provide Medicare
payment for a dental or oral examination as part of a comprehensive
workup and the necessary dental treatments and diagnostics to eliminate
oral or dental infections prior to cardiac valve replacement or
valvuloplasty procedures. Commenters indicated that poor dental health
has proven to be highly associated with chronic disease and higher
cardiovascular risks and that oral infections can undermine recovery
from cardiac valve replacement or valvuloplasty procedures. Commenters
also stated that dental infections and poor oral health increase the
risk of infection in a newly implanted heart valve, and that patients
may have primary bacterial endocarditis or secondary prosthetic valve
endocarditis to neglected dental health and chronic dental abscesses.
The commenters further stated that these life-threatening situations
could be prevented with the provision of medically necessary oral or
dental services prior to and, as necessary, during a cardiac valve
replacement or valvuloplasty procedure.
Response: We appreciate commenters' support regarding these
proposed updates to the existing policy for payment under Medicare
Parts A and B for dental services that are inextricably linked to, and
substantially related and integral to the clinical success of certain
covered medical services, and provided prior to and/or
contemporaneously with, those covered medical services, such as cardiac
valve replacement and valvuloplasty procedures. We agree that the
evidence supports that dental examinations, including necessary
treatment, performed as part of a comprehensive workup prior to and/or
contemporaneously with cardiac valve replacement or valvuloplasty
procedures, are inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services. Specifically, we note that after a valve replacement, the
valve is at risk of being a seeding source for future endocarditis.
Endocarditis can carry high risk for mortality for these patients, so
eliminating an infection prior to or contemporaneously with the
procedure would be important for preventing future endocarditis seeding
at the new valve.
For these reasons, we are finalizing our proposal that Medicare
Part A and Part B payment can be made for certain dental services, such
as dental or oral examinations, including necessary treatment,
performed as part of a comprehensive workup prior to, and/or
contemporaneously with, cardiac valve replacement or valvuloplasty
procedures, that are inextricably linked to, and substantially related
and integral to the clinical success of, the procedures.
Comment: Several commenters suggested that CMS provide additional
guidance that would aid in processing claims for dental services that
are inextricably linked to the Medicare-covered medical service.
Commenters suggested we provide additional guidance about what types of
specific dental treatments would be billable if provided under our
finalized policy prior to, or contemporaneously with, Medicare-covered
organ transplant, heart valve replacement, and valvuloplasty
procedures. Some commenters requested CMS issue specific procedure and
diagnosis codes associated with this policy. Other commenters
recommended specific professional services codes, procedure codes and
diagnosis codes for CMS to reference. Many commenters requested this
information to allow a consistent application of the policy and for
clinical decision-making purposes. A few commenters requested that CMS
require the use of a modifier to identify dental services and claims
that are inextricably linked to, and substantially related and integral
to the clinical success of, certain covered medical services. Others
requested that CMS implement prior authorization policies so that
healthcare professionals have prior approval of the inextricable
linkage between the dental and medical services. However, some
commenters argued that the use of modifiers or prior authorization
could be overly burdensome to providers.
Response: We appreciate the commenters' request for additional
guidance regarding how to identify what services may be payable, such
as the use of modifiers or the prior authorization process, and how to
ensure that the claims themselves can be successfully processed.
Additionally, we note that if clinically necessary, Medicare could
make payment for dental services occurring over multiple visits. We
recognize that it may not be clinically appropriate to receive the
totality of dental services, which are necessary to immediately
eradicate an infection, that are inextricably linked to the covered
medical services, within one visit. As such, Medicare could make
payment, for example, for the required dental services immediately
necessary to eradicate the infection if such services require multiple
dental services and it is clinically advisable for those services to
occur over multiple visits prior medical services such as an organ
transplant, cardiac valve replacement, or valvuloplasty procedures.
We will continue to consider commenters' request for additional
specific considerations and scenarios, and may issue additional
guidance or further address our policies in this area in future
rulemaking. Furthermore, we will provide guidance to the MACs to assist
them in determining this inextricable link between dental and medical
services so that they can continue to make determinations on a claim-
by-claim basis for patient and clinical circumstances do or do not fall
within the examples of services listed under Sec. 411.15(i), or within
the preclusion or exception specified in section 1862(a)(12) of the Act
and Sec. 411.15(i).
Additionally, we are continuing to explore commenters' suggestions
that we use claim modifiers or prior authorization policies.
Comment: Multiple commenters supported the proposal that certain
dental services that are substantially related and integral to the
clinical success of organ transplant, cardiac valve replacement, or
valvuloplasty procedure can occur within the inpatient hospital or
outpatient settings and agreed that Medicare Parts A and B payment
should be made for associated dental services, regardless of whether
the services are furnished in an inpatient or outpatient setting.
Response: We appreciate the commenters' support regarding the
settings in which payment can be made for dental services. We agree
that payment can be made for dental services that are inextricably
linked, and substantially related and integral to the clinical success
of, certain covered medical services can be furnished in multiple
settings. As such, we are finalizing that Medicare Parts A and B
payment can be made for such covered
[[Page 69679]]
dental services, as applicable, regardless of whether the services are
furnished in an inpatient or outpatient setting, as clinically
appropriate; and that payment under the applicable payment system. We
will also make updates to appropriate Medicare payment data files to
ensure that appropriate payments can be made under the applicable
payment system. We note that this policy is consistent with the payment
policy as specified within our existing manual guidance (See Medicare
Benefit Policy Manual (IOM Pub 100-02, Chapter 15, section 150).)
Comment: Several commenters supported our proposal that payment
under the applicable payment system could also be made for services
that are ancillary to dental services for which Medicare payment can be
made, such as x-rays, administration of anesthesia, and use of the
operating room.
Response: We appreciate the commenters' support and agree that
payment can be made for ancillary services or supplies associated with
the provision of covered, medically necessary dental services. As such,
we are finalizing our proposal that payment under the applicable
payment system could also be made for services that are ancillary to
these dental services, such as x-rays, administration of anesthesia,
and use of the operating room.
Comment: Several commenters requested additional information
regarding the operational aspects of both the proposal to codify and
clarify existing policy and the proposal to update dental services that
are inextricably linked to, and substantially related and integral to
the clinical success of, the covered medical services. Specifically,
commenters raised concerns about issues, including: (1) what claims
form dentists would use to submit claims for dental services; (2) what
procedure code set and what diagnostic codes would be reflected on the
claims; (3) if National Coverage Determinations (NCDs) will be issued
to ensure consistent claim payment across the country; (4)
clarification on any frequency limits, documentation requirements, and
authorization processes; and (5) Medicare enrollment processes for
dentists and any efforts CMS may make to ensure network adequacy.
Other commenters suggested that CMS establish a demonstration to
initially test the operational feasibility of a Medicare payment policy
of this magnitude. These commenters suggested, that by using a
demonstration format for payment in this manner, we could continue to
refine the policy and operational aspects of the policy with input from
interested parties prior to implementing nationally.
Response: We appreciate the commenters' thoughtful feedback and
questions. We note first that under our current policy (which is being
codified in this final rule), dental services with an inextricable
linked to certain Medicare-covered medical services can, and have been,
paid under Medicare Parts A and B. At this time, dentists, as
appropriate, should continue to enroll in Medicare according to the
current process. Dentists and other qualified practitioners who furnish
dental services that are eligible for payment under Parts A and B
(because they are inextricably linked to another Medicare-covered
medical service) should continue to submit claims using current
processes, and can consult with their MACs for specific claims
submission questions.
However, we also recognize that with the codification and
clarification of our policies regarding dental services that are
inextricably linked to Medicare-covered medical services (including
prior to organ transplant, cardiac valve replacement, and
valvuloplasty), the volume of dental service claims being submitted may
increase. We appreciate the commenters' thoughtful feedback and
questions regarding the operational aspects of this proposal, and we
agree that these are necessary areas to address. We acknowledge the
need to address and clarify certain operational issues, and we are
working to address these issues, including claims processing questions
raised by the commenters. We anticipate resolving many of the
additional operational issues raised by commenters potentially as soon
as CY 2024, including efforts to adopt the dental claim form. We will
also make updates to appropriate Medicare payment data files to ensure
that covered dental services can be billed and paid (in a manner
described below) based on the applicable payment system for services
furnished. We will continue to work with our MACs and encourage
continued feedback from interested parties to help identify concerns or
questions regarding submission and processing of dental claims. We also
plan to provide guidance and engage in further rulemaking, as
necessary, as operational strategies and plans are refined and
implemented. We will also monitor service utilization to identify any
concerns about consistency of claims processing and adequacy of access
across the country. We appreciate the questions raised by commenters
and plan to take them into consideration as we continue to refine
operational issues relating to this policy, and make any necessary
refinements.
Comment: Several commenters supported our proposal to continue to
contractor price dental services that are substantially related and
integral to the clinical success of certain covered medical services
for CY 2023, or until such time that CMS has data to establish
prospective payment rates. Conversely, several commenters objected to
MAC-specified payment, as the commenters expressed concern regarding
potential for incongruent payment amounts based on MAC region and also
expressed apprehension regarding potential health equity impacts if
payments were not aligned across geographies. Commenters made
recommendations regarding the creation of a framework that ensures
applicable payment policies across MAC regions and also requested
annual updates for these payments. Other commenters requested that CMS
encourage the use of specific public data sources in setting payment
rates for dental services, and in order to account for geographic
variations in the costs of providing dental and oral services.
Response: We appreciate the commenters' feedback regarding our
proposal to contractor price dental services that are inextricably
linked to, and substantially related and integral to the clinical
success of, certain covered medical services, including organ
transplant, cardiac valve replacement, or valvuloplasty procedures. We
continue to believe that MACs are appropriately situated to establish
contractor prices for these services given that the MACs currently
establish contractor pricing for the dental services for which payment
is currently made. As it is for dental services currently payable under
Medicare Parts A and B, we believe that it is appropriate to continue
contractor pricing for dental services for which payment is made in the
additional clinical scenario examples we are finalizing in this final
rule, until we have additional pricing data that could enable national
pricing. As such, we are finalizing our proposal to continue to
contractor price these services based on the applicable payment system
for services furnished. However, we agree with the suggestions made by
commenters that there may be publicly available data sources that could
aid MACs in determining these payment rates. We plan to issue
operational guidance to the MACs for these final policies and will note
the potential usefulness of these data sources when establishing
payment rates for these applicable dental services.
[[Page 69680]]
Comment: A few commenters expressed concerns regarding the
financial impact of possible payment under Medicare Parts A and B for
dental services substantially related and integral to the clinical
success of certain covered medical services, including organ
transplant, cardiac valve replacement, or valvuloplasty procedures. The
commenters stated that these services are high-volume procedures and
expressed concerns that paying for these dental services through the
PFS would negatively impact the budget neutrality adjustments to the
conversion factor, and would negatively impact payments for other
physicians' services. These commenters urged CMS to consider the
implications on the PFS payment system prior to finalizing any expanded
policy in this area, or until financial impact was better understood
and available for interested parties' review and comment.
Response: We appreciate the commenters' feedback regarding possible
financial impacts for payments made under Medicare Part A and Part B
for dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, certain covered
medical services. Also, we proposed to clarify our interpretation of
section 1862(a)(12) of the Act and codify certain aspects of our
current Medicare PFS payment policies for dental services. We also
proposed and sought comment on payment for other dental services, such
as dental exams and potential necessary treatments prior to organ
transplants, cardiac valve replacements and valvuloplasty. Because we
proposed to codify and update existing policy, these proposals would
not impact budget neutrality under the PFS, or require adjustments to
the PFS conversion factor. Additionally, while we recognize that the
impact of access to these services to individual beneficiaries may be
very significant, we still do not anticipate significant impact in the
context of overall spending and utilization under the Physician Fee
Schedule. We intend to closely study the trends in utilization and
payment for these services and make refinements to the payment policy
as needed in future rulemaking.
Other Clinical Scenarios for Dental Services Integral to Other Covered
Medical Services
Comment: Many commenters supported our suggestions that dental care
may be inextricably linked to the clinical success of, treatments for
head and neck cancer, immunosuppressive therapy, or joint replacement.
Commenters also noted general support for coverage of dental care in
both inpatient and outpatient settings, and coverage of ancillary
services such as x-rays and anesthesia, needed to perform any covered
dental care. Many commenters supplied data and studies that spoke to
the prevalence of chronic conditions or health disparities among
different populations, as well as information supporting the benefits
of good dental health. However, only a few commenters provided clinical
evidence with their comments to explicitly support the link between
dental services and the clinical success of these specific medical
services.
Many commenters noted that without clear definitions or narrowly
tailored guidance, identifying dental services that are inextricably
linked to, and substantially related and integral to the clinical
success of, a certain covered medical service may prove challenging.
Several commenters noted that this standard could be interpreted overly
broadly since, as many commenters noted, there is a great deal of
evidence suggesting that dental health is generally an important
component of overall health. Alternatively, a few commenters were
concerned that this standard could be interpreted too narrowly, such as
by assuming that a dental service must always be performed
contemporaneously with another covered procedure to be considered
``integral'' to that procedure. These commenters collectively worried
that beneficiaries, practitioners, and MACs may be confused about what
dental services can be covered, which would lead to inconsistent
payment of claims and potential unanticipated financial burdens on
beneficiaries or practitioners.
Response: We thank the commenters for these insights and agree that
these are critical issues to consider as we review recommendations and
clinical evidence relating to Medicare payment for dental services.
However, we note that while many commenters expressed support for the
inextricable link between dental services and medical services such as
immunosuppressive therapy, or joint replacement, we do not currently
believe we have sufficient clinical evidence to fully evaluate whether
certain dental services are inextricably linked to, and substantially
related to the clinical success of, medical services such as the
initiation of immunosuppressant therapy, or joint replacement
surgeries, and need more time to review. We will continue to review the
information submitted by commenters during the rulemaking cycle, and we
encourage the public to provide additional information, including
through the finalized process under section II.L.2.c.ii. of this rule.
Comment: Many commenters agreed with our analysis that dental
services prior to head and neck cancer treatments are integral to the
clinical success of those treatments. One commenter recommended that we
specify that by ``head and neck cancer,'' we are referring to treatment
for patients with cancer related to the ``mid-neck through skull.''
Many commenters provided links to resources that they believed provided
clinical evidence to support the link between dental care and the
clinical success of, or standard of care for patients receiving
treatment for head and neck cancer. Commenters also provided numerous
examples of the consequences that can occur if cancer treatment is
undertaken in a patient with poor dental health, and shared personal
experiences to note the interrelationship between dental health and
cancer treatment, including the physical and financial impacts of the
extensive damage that can be caused by poor dental health during and
after cancer treatments.
Commenters also submitted specific information showing that
radiation therapy used to treat head and neck cancer can cause a number
of oral conditions, including radiation caries, problems with the
salivary glands, mucositis, candidiasis, dysgeusia, xerostomia (dry
mouth), and osteoradionecrosis (bone cell death) of the jaw. Several
commenters noted that osteoradionecrosis, if not prevented, is
difficult to treat and can necessitate surgery that may disfigure and
functionally impair the patient's face and jaw. Several commenters also
provided data illustrating that conditions such as mucositis or
osteonecrosis may require multiple hospitalizations and other costly
treatment.
Commenters suggested that if dental infections are not addressed
prior to radiation treatment, the treatment may be less effective, or
the patient may be prone to other infections. One commenter stated that
treating dental infections prior to the start of radiation can reduce
some of the tissue damage in the mouth that can result from the
radiation. Several commenters shared studies to support the assertion
that dental care prior to radiation treatment is integral to the
clinical success of head and neck cancer treatment and survivorship
(although one commenter noted that the reasons why dental care prior to
radiation therapy improves survival rates is not entirely clear).
Several commenters observed that
[[Page 69681]]
Medicare already covers extractions of teeth prior to radiation
treatment for neoplastic disease, and regarded dental exams as a close
analog to this preparatory care.
Commenters also provided information showing that chemotherapy
drugs used for treatment of head and neck cancers can have many side
effects, including sores and lesions in the mouth and throat tissues,
difficulty swallowing, bleeding in the mouth, and tooth decay.
Additionally, commenters stated that because chemotherapy reduces the
body's ability to fight opportunistic infections, patients who begin
chemotherapy with untreated infections (including infections in the
oral cavity) are at risk of developing a number of complications,
ranging from fungal or viral infections of the mouth and throat to
systemic infections or fatal sepsis. Commenters observed that
complications arising from untreated infections could cause treatment
interruptions which could compromise the success of the treatment and
the patient's outcomes. One commenter observed that the need for
removing oral infection prior to starting chemotherapy is analogous to
the rationale for providing oral care prior to renal transplant, and
thus (like dental exam prior to renal transplant) should be considered
substantially related and inextricably linked to the clinical success
of the treatment. Commenters recommended that patients receiving
chemotherapy for head or neck cancer receive a dental exam and
stabilization, if applicable. Several commenters noted that providing
an oral exam prior to starting chemotherapy is the standard of care in
many cancer centers.
Response: We thank the commenters for the information. We
appreciate the individual examples and the clinical information
commenters shared illustrating connections between head and neck cancer
treatments and dental care. We will continue to refer to the relevant
conditions by the common term ``head and neck cancer,'' but appreciate
the suggested clarification offered by one of the commenters and will
consider further refining what is meant by ``head and neck cancers,''
beyond the treatment such as radiation therapy with or without
chemotherapy, as part of our ongoing operationalization work.
As discussed in sections II.L.1. and II.L2. of this rule, we are
finalizing the codification of existing Medicare payment policy provide
that payment can be made under Medicare Parts A and B for extractions
of teeth to prepare the jaw for radiation treatment of neoplastic
disease. We agree with commenters that providing dental exams and
necessary treatments to eradicate infection and/or otherwise prepare
the oral cavity for the treatment of head and neck cancer presents an
analogous clinical circumstance for which we currently provide payment.
We note that the presentation of an analogous clinical circumstance is
not the sole basis on which we plan to add head and neck cancer
treatments to our list of examples in Sec. 411.15(i) of dental
services that are inextricably linked to Medicare-covered medical
services. However, we find that the analogous clinical circumstance
between head and neck cancer treatment and radiation treatment in the
jaw, in addition to clinical evidence showing an inextricable link
between dental services and the success of head and neck cancer
treatment (discussed below) is compelling.
We find clinical evidence supplied by commenters linking dental
care and the clinical outcomes of cancer treatments for head and neck
cancers persuasive. We looked particularly to a systematic review and
meta-analysis cited by commenters that was supportive of the
inextricable link between dental care and successful treatment of head
and neck cancer, showing a significantly higher survival rate in those
who receive recommended dental care prior to and during treatment of
their cancer.\126\ We also received references from several commenters
to a literature review that concluded that good oral hygiene (including
topical fluoride treatments) is critical for patients being treated
with radiation for head and neck cancer, due to the lowered biological
potential for healing of the periodontium (alveolar bone, periodontal
ligament, cementum) after radiotherapy.\127\ We believe that this
information is sufficient to support the basic assertion that removing
infections in the oral cavity (in addition to potentially removing
teeth) is necessary to prepare patients for treatment and is
inextricably linked to, and substantially related and integral to the
clinical success of radiation treatment (with or without chemotherapy)
for cancers of the head and neck. As such, we are finalizing a policy
for CY 2024 that Medicare Parts A and B payment may be made for dental
or oral examination performed as part of a comprehensive workup in
either the inpatient or outpatient setting (as well as medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection), prior to or contemporaneously with Medicare-covered
treatments for head and neck cancer.
---------------------------------------------------------------------------
\126\ Refer to Haynes, D., Vanison, C., Gillespie, M.,
Laryngoscope 2022 Jan;132(1):45-52. doi: 10.1002/lary.29494. Epub
2021 Feb 26. The Impact of Dental Care in Head and Neck Cancer
Outcomes: A Systematic Review and Meta-Analysis.
\127\ Refer to Acharya, A. Geist, S.-M.R.Y., Powell, V. &
Torres-Urquidy, M.H. (2019). Chapter 3: An environmental scan of the
various oral-systemic contact points. In Acharya, A. Powell, V.,
Torres-Urquidy, M.H., Posteraro, R.H., & Thyvalikakath, T.P. (Eds.),
Integration of medical and dental care and patient data (2nd ed.,
pp.35-46), citing to Vissink A, Burlage FR, Spijkervet FK, et al.
Prevention and treatment of the consequences of head and neck
radiotherapy. Crit Rev Oral Biol Med. 2003;14(3):213-25.
---------------------------------------------------------------------------
We believe there are several aspects of this policy that may
require additional refinement or clarification. As noted in an earlier
response, we are cognizant of concerns that, absent clear guidelines
and definitions, beneficiaries, practitioners, and MACs may need
additional information prior to providing payment under Medicare Parts
A and B, and without it could lead to inconsistent application of the
policy. In particular, we believe it is important to determine whether
any additional guidance is necessary to identify conditions considered
``head and neck cancer'' and qualifying covered medical services
considered within the treatments for these cancers beyond just
radiation (with or without chemotherapy). ``Head and neck cancer'' is a
commonly-used term that describes a number of specific conditions; the
treatments for these cancers are delivered through multiple modalities.
We would also like to review and consider specifically if ``head and
neck cancers'' implies any neoplasm, whether primary or metastatic,
located in the head and neck, regardless of where the cancer
originated. We would like to review and consider whether further
definitions and guidance are necessary. Additionally, given that some
patients might undergo medical services under multiple rounds of
treatment, we plan to review how this is applied when payment may be
made for dental services provided prior to or contemporaneously with
covered medical services.
We believe finalizing this policy for CY 2024 will acknowledge our
agreement with commenters that the clinical scenario of dental services
associated with head and neck cancers is one where Medicare Part A and
Part B payment could be made in accordance with our interpretation of
section 1862(a)(12), and also allow us to continue to engage with
interested parties to further develop and refine the policy as
necessary in the interim. We reiterate that we are open to additional
refinements or clarifications to our definitions of head and neck
cancer treatment, which we would develop and
[[Page 69682]]
discuss through future rulemaking or through additional guidance as
needed or necessary. We also note that the finalized policies outlined
in this section of this final rule (including the policy we are
finalizing here for CY 2024) would not prevent a MAC from making
determinations on a claim-by-claim basis for dental services furnished
in other circumstances not specifically addressed within this final
rule and the finalized amendments to Sec. 411.15(i).
We also encourage interested parties to submit additional
information through the process that we are finalizing under section
II.L.2.c.ii. of this rule that could inform further refinements or
clarifications to this policy.
Comment: Several commenters recommended that we pay for additional
types of dental services, such as preventive, diagnostic (including
imaging), periodontal, caries removal, and extractions in both hospital
inpatient and outpatient settings. Commenters recommended dental
services including exam, extraction, scaling, and root planing as
needed prior to and in some cases during cancer treatment.
Additionally, several commenters recommended fluoride treatment for
patients receiving radiation therapy for head and neck cancer to help
strengthen the teeth. Several commenters provided lists of specific
dental codes that should be payable.
Response: We thank the commenters for the specific suggestions. As
noted above, we are finalizing a policy for CY 2024 that Medicare Parts
A and B payment may be made for dental or oral examination performed as
part of a comprehensive workup in either the inpatient or outpatient
setting (as well as medically necessary diagnostic and treatment
services to eliminate an oral or dental infection), prior to Medicare-
covered treatments for head and neck cancer. We will make conforming
edits to Sec. 411.15(i)(3) for CY 2024 to add to our list of examples
of dental services that may be paid under Medicare Parts A and B dental
or oral examination performed as part of a comprehensive workup in
either the inpatient or outpatient setting (as well as medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection), prior to Medicare-covered treatments for head and
neck cancer. We will continue to make refinements to the policy as
necessary, which we would discuss through future rulemaking or through
additional guidance as needed.
We note again that the finalized policies outlined in this section
of this final rule would not prevent a MAC from making a determination
that payment can be made for dental services in other circumstances not
specifically addressed within this final rule and the finalized
amendments to Sec. 411.15(i). Under the PFS, we will continue to
contractor price the dental services for which payment can be made in
accordance with our regulation at Sec. 411.15(i)(3) as inextricably
linked to, and integral to the clinical success of, covered medical
services. This includes dental services for which payment may be made
under our current payment policy, which we are codifying and
clarifying, those for which payment can be made under the finalized
amendments to Sec. 411.15(i)(3), and other dental services for which
MACs may determine payment can be made. We note that we will continue
to contractor price covered dental services prior to head and neck
cancer treatments, consistent with our current policy, until we have
further data to establish prospective payment rates. We will also
update associated payment files so that these services can be billed
appropriately under the applicable payment system for services
furnished in either the inpatient or outpatient setting.
Comment: Some commenters recommended that patients treated for head
and neck cancer receive follow-up or ongoing dental care after
treatment, noting that patients continue to be at risk for many or all
of the conditions discussed above (including dental caries,
osteonecrosis, and so forth) even after treatment is concluded. Some
commenters noted that there is a period after treatment when patients
remain immunosuppressed, and recommended that follow-up care be
provided until the immunosuppression ends and, as applicable, when all
dental infections are resolved. Several other commenters also described
scenarios in which teeth may become impacted or brittle after radiation
treatment and require eventual extraction after the radiation therapy
has concluded. Other commenters noted that it is not always possible to
perform restorative surgeries at the same time as the cancer treatment
and requested that we pay for restorative dental services performed on
a later date.
Response: As discussed, we are finalizing for CY 2024 that payment
can be made under Medicare Parts A and B for dental services furnished
prior to or contemporaneously with head and neck cancer treatment in
order to prepare the patient's oral cavity for treatment; we will
continue to review feedback provide by commenters regarding potential
follow-up dental services necessary for patients receiving head or neck
cancer treatments to consider whether dental services provided after
the medical service are inextricably linked to, and substantially
related and integral to the clinical success of, other covered medical
services for head and neck cancer.
Comment: Some commenters also suggested that we clarify whether
Medicare payment would extend to surgical procedures to fix physical
damage caused by cancer treatments; commenters observed that surgical
reconstructions can be essential to restoring capacity to eat, drink,
and swallow to maintain nutrition and overall health. Commenters noted
that we already pay for procedures like ridge repair when they are
performed simultaneously with tumor removal. One commenter provided a
list of recommended services for which Medicare Parts A and B should
payment for patients who have had portions of bone removed as a result
of cancer treatment. Another commenter also suggested we define
specific dental services allowed for patients who had gum removal due
to mouth cancer.
Response: We thank the commenters for their suggestions. The
commenters provided a number of scenarios, with varying level of
detail, and we cannot, at this time, make categorical statements about
whether the scenarios presented by commenters would be payable under
Medicare Parts A and B. Some scenarios that commenters provided may be
contemplating might fall within our statutory exclusion of dental
services at section 1862(a)(12) of the Act, which prohibits Medicare
payment for the care, treatment, filling, removal, or replacement of
teeth or structures directly supporting teeth. However, others
depending on the specific circumstances may fall within our policy for
dental services performed prior to or contemporaneously with Medicare-
covered treatment for head and neck cancer. We note that the policies
finalized in this section do not prevent a MAC from making appropriate
determinations, on a claim-by-claim basis, as to whether a patient's
clinical scenario fits within the terms of the exceptions specified in
section 1862(a)(12) of the Act and Sec. 411.15(i).
Comment: Commenters also noted that patients with other types of
cancer would benefit from coverage of dental examinations prior to or
after cancer treatment. Many commenters recommended that we expand
payment of dental care to all cancer patients. Commenters noted that
the increased risk of infections and sepsis among cancer patients can
constitute major health setbacks that are costly to treat
[[Page 69683]]
and can compromise the success of the cancer treatment.
Response: We thank the commenters for the additional information.
We will continue to review and evaluate information that supports the
relationship between dental care and covered treatments (including
treatments related to conditions not localized in the head, neck, or
oral cavity). Please refer to the discussion in L.2.c.ii. relating to
our finalized policy to create a process to review recommendations for
other scenarios in which dental care may be inextricably linked, and
substantially related and integral to the clinical success of, covered
medical services.
Comment: We received many comments in response to our request for
information about the relationship between dental care and
immunosuppressant treatments. Commenters shared personal experiences of
dental challenges arising from immunosuppression. Commenters also noted
that some individuals without dental coverage often cannot afford
dental treatment and may be left with an impaired ability to eat,
speak, or swallow. Many of these commenters discussed how general
dental health, or routine dental care, impacts a patient's overall
health.
Commenters recommended Medicare pay for dental care for patients
taking immunosuppressants for a variety of auto-immune conditions. We
also received many comments recommending that we pay for dental
services for patients on immune checkpoint inhibitors, patients on
immunosuppressants as part of a cancer treatment, or who have
experienced immunosuppression as a result of cancer treatments, and
patients taking immunosuppressants following a transplant surgery.
Several commenters stated that evidence suggests that screening for and
treatment of oral inflammation and infections, including decay
(extractions, fillings), gingivitis, and periodontitis (scaling and
root planing), should begin pre-transplantation and continue as
appropriate post-transplantation, after 3-6 months, to prevent sepsis
and organ rejection until immunosuppression is resolved.
These commenters noted that immunocompromised patients are at
increased risk of serious infection that can lead to severe conditions.
Some commenters noted that individuals with blood cancers, such as
leukemia and lymphoma, or other types of cancers may be prone to
infections. Other commenters noted that older adults naturally have
lowered immune systems, which can compound the effects of a weakened
immune system and that patients on immunosuppressive therapies with
secondary health conditions can also be especially susceptible to
dental infections. Some commenters provided clinical evidence that they
indicated supported the need for Medicare payment, while others did not
include references. Additionally, several commenters stated that
additional time was needed for interested parties to consider the
inextricable link between dental services and medical services for
immunocompromised patients. Others ask clarifying questions and how
immunocompromised could be defined and which types of therapies could
meet the definition. Others asked how CMS planned to define an
immunocompromised patient, while additional commenters asked whether
certain clinical scenarios or therapies with immunosuppressive side
effects would meet the definition of ``immunocompromised'' for the
purposes of this policy. Lastly, some commenters provided clinical
scenarios where they stated cause a patient to be susceptible to
infection, and therefore, are immunocompromised.
Response: We thank the commenters for both the personal and
clinical information regarding the interrelationship between various
immunocompromised and immunosuppressed conditions and dental health.
Some commenters provided clinical evidence related to dental services
for people who are immunocompromised or who are receiving therapies
that cause immunosuppression, others provided opinion pieces, no
supporting clinical literature, or literature to support that general
dental health benefits a patient's overall health.
We appreciate the many thoughtful questions and comments raised by
commenters surrounding how to define immunosuppression or an
immunocompromised patient. As discussed, we continue to consider these
questions and the clinical literature provided by commenters to
determine whether other clinical scenarios, such as the initiation of
immunosuppressive therapies, where Medicare payment should not be
excluded for dental services under section 1862(a)(12) of the Act
because the services are inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services. We agree with commenters that people who are
immunocompromised may be prone to serious infection. We also believe
that information provided by commenters further supports the idea that,
broadly, dental health is an important component of good overall
health. However, we reiterate that dental services in connection with
the care, treatment, filling, removal, or replacement of teeth, or
structures directly supporting the teeth are statutorily excluded from
payment under Medicare Parts A and B unless a specific exception
applies.
We agree with commenters that beneficiaries undergoing treatment
for bone cancers could be immunocompromised and also prone to
infection. We note that treatment protocols for some of these patients
could include bone marrow transplants, and, as described previously, we
are finalizing that Medicare Parts A and B payment can be made for
dental services prior to and contemporaneously with organ transplants,
including bone marrow transplants.
Some commenters requested that CMS take additional time to review
the clinical literature and to engage with CMS to a payment policy in
this area further. Given the clarifying questions raised by commenters
and the need to future review the clinical literature to determine
whether there is an inextricable link between dental services and the
medical services treating conditions for immunocompromised patients, we
agree with commenters and believe we need additional time to consider
definitions surrounding immunosuppressant therapy (such as distinctions
between therapies prescribed specifically for their immunosuppressive
effect and therapies that are prescribed to treat a different condition
but have a side effect of immunosuppression). We look forward to
reviewing clinical evidence that will help us to identify among these
clinical scenarios where dental services are inextricably linked with
specific clinical outcomes of a medical services of people with
immunosuppression. Such review may allow us to propose relevant
policies in next year's notice and comment rulemaking.
As discussed, we are open to continued engagement with interested
parties through the process that we will be creating under our final
policy as described in section II.L.2.c.ii. of this rule, and to
considering future refinements to our policy through potential guidance
or future rulemaking as needed. These specific questions are ones that
we will explore and contemplate further in CY 2024 rulemaking and
through the finalized process to review recommendations for future
rulemaking. We encourage parties
[[Page 69684]]
interested in this specific policy to engage with us through the
process as described in section II.L.2.c.ii. of this rule.
Specifically, we would encourage interested parties to submit medical
evidence to support the inextricable link between dental services and
the medical services involved in treating immunosuppressed patients
(for example, empiric evidence to support a strong association between
dental services prior to the initiation immunosuppressive therapies and
reduced infection) by providing any of the following: (1) relevant
peer-reviewed medical literature and research/studies regarding the
medical scenarios requiring medically necessary dental care; (2)
evidence of clinical guidelines or generally accepted standards of care
for the suggested clinical scenario (we would prefer the clinical
guidelines to have undergone clinical rigor in their development); (3)
other supporting documentation to justify the inclusion of the proposed
medical clinical scenario requiring dental services; and/or (4)
suggestions for definitions, and supporting rationales for those
definitions, surrounding this policy for further consideration.
Comment: Some commenters supported the idea that dental care prior
to joint replacement surgery or joint arthroplasty could be beneficial.
One commenter observed that as hip and knee replacements are among the
most common joint replacement surgeries, providing dental care to
patients prior to hip and knee surgeries would benefit a large number
of joint replacement recipients. Commenters offered some research
studies showing that dental care prior to a joint replacement was
associated with a reduction of infection at the surgical site. Some
commenters also noted that dental care prior to any type of surgery may
have a positive impact with only some commenters providing supporting
evidence. Other commenters noted that additional time was necessary to
review whether there was an inextricable linkage between dental
services and joint replacement surgeries. Others also commented that
clinical evidence is lacking to support the causation between dental
services and the success of joint replacement surgeries. Some
commenters providing clinical evidence to support that the clinical
evidence for antibiotic use prior to joint replacement surgery was
inconclusive.
Response: We thank the commenters for the information regarding the
possible relationship between joint replacement surgery and dental
health. Several commenters discussed the benefits that good dental
health has on general outcomes for joint replacement surgeries rather
than the inextricable linkage between dental services and the
arthroplasty procedure. Although some commenters were supportive, we
are unable to determine from the studies and other evidence we received
whether there is an inextricable link to the clinical success of joint
replacement surgery and dental care. It is important for us to
delineate between evidence suggesting that dental services are integral
to the clinical success of the covered medical services and evidence
suggesting a possible improvement in outcomes for a medical condition.
We also encourage interested parties to submit additional information
through the process that we are finalizing under section II.L.2.c.ii.
of this rule that could inform further refinements or clarifications.
Specifically, we would encourage interested parties to submit medical
evidence to support the inextricable link between dental services and
the medical services involved in joint replacement surgeries (for
example, empiric evidence to support a causal inference of dental
services being necessary before joint replacement surgeries to prevent
infection) by providing any of the following: (1) relevant peer-
reviewed medical literature and research/studies regarding the medical
scenarios requiring medically necessary dental care; (2) evidence of
clinical guidelines or generally accepted standards of care for the
suggested clinical scenario (we would prefer the clinical guidelines to
have undergone clinical rigor in their development); (3) other
supporting documentation to justify the inclusion of the proposed
medical clinical scenario requiring dental services; and/or (4)
suggestions for definitions, and supporting rationales for those
definitions, surrounding this policy for further consideration.
Comment: We received general support for permitting payment for
dental care that might be associated with traumatic injury of the jaw.
One commenter also provided a list of congenital maxillofacial
conditions that require surgical repair.
Response: We thank commenters for their support. We note that we
are finalizing our proposal to codify and clarify current payment
policies related to services such as, but not limited to, the
stabilization of teeth when done in connection with a reduction of a
jaw fracture and certain dental services associated with a dislocated
jaw unit regardless of whether the services are associated with
accidental injury. We note that these services would not be subject to
the exclusion under section 1862(a)(12) of the Act, and would be
eligible for Medicare payment. We are uncertain if the recommendations
we received from commenters are referring to services that are already
covered by the exception under section 1862(a)(12) of the Act or if the
commenters were describing services the commenters believed to be
currently excluded from payment under Medicare Parts A and B. We
encourage these commenters to discuss with us further whether they were
referring to dental services prior to maxillofacial surgeries or just
the maxillofacial surgeries themselves. We also encourage interested
parties to submit additional information through the process that we
are finalizing under section II.L.2.c.ii. of this rule that could
inform further refinements or clarifications.
Establishment of a Process To Consider Additional Clinical Scenarios
for Future Updates
Comment: The majority of commenters supported the creation of a
process for considering whether there are additional examples clinical
scenarios where dental services may be inextricably linked to, and
substantially related and integral to the clinical success of, other
covered medical services. These commenters stated that such a process
would allow for further clinical evaluation and analysis of the
inextricable link between certain medical and dental services. These
commenters also stated that clear definitions of the link between
medical and dental services would be beneficial, as such a process
would also allow for a thorough exploration of the threshold of this
connection, and further definition of immediately necessary, integral
dental treatments. Commenters stated that the evaluation of the
efficacy other medically necessary dental treatments for covered
medical services should rely on comprehensive clinical reports to
confirm the intrinsic relationship of the dental services to a certain
medical outcome. These commenters urged CMS to engage with interested
parties through the creation of an advisory panel or formal process.
Response: We appreciate the commenters' support regarding the
establishment of a process for the consideration of additional examples
of clinical scenarios that we should consider for future updates to our
regulation at Sec. 411.15(i)(3) to identify dental services that may
be inextricably linked to, and substantially related and integral to
the clinical success of, other covered medical services. We believe
such a process will allow for review,
[[Page 69685]]
evaluation, and modification to the list of those dental services for
which payment is not excluded under the statute at section 1862(a)(12)
of the Act and can be made under Medicare Parts A and B. We agree with
commenters that the establishment of a process would also allow for a
thorough review of clinical evidence, allow CMS to modernize policies
with evolving medical advances, and engage with interested parties.
Comment: Several commenters provided recommendations regarding
possible features for a potential process for consideration of
additional clinical scenarios. Commenters asserted that the annual
notice and comment rulemaking process for the PFS serves as an
appropriate mechanism for CMS to consistently revisit the process for
and identification of covered medical conditions and associated dental
services that are substantially related and integral to the clinical
success of the proposed covered medical services.
Several commenters stated that the clinical examination of proposed
additional scenarios should be transparent and open to the public, with
the agency providing notification regarding any dental, medical, or
other groups that submit such suggested procedures.
A few commenters requested that CMS institute a process to allow
medical and dental experts to serve on an advisory panel that would
hear and evaluate relevant evidence and research on which covered
medical services require dental services that are substantially related
and integral to the clinical success of the covered medical services.
The commenters contended that thorough clinical consideration should
occur for each proposal before any additional scenarios are considered
payable.
A few commenters also requested that CMS require the presentation
and review of research, as well as clinical evidence to justify the
link between a proposed, covered Medicare Parts A or B medical service
and dental services that are inextricably linked to, substantially
related and integral to the clinical success of certain covered medical
services. Commenters suggested that the requirements for submission
should include clinical evidence that demonstrates that dental services
are effective in addressing the proposed medical scenario, treatment
timelines for each medical diagnosis and correlated dental care for the
stage(s) of the disease, and other considerations for communication or
coordination amongst the care team.
Several commenters requested that CMS expressly solicit proposals
regarding the ancillary services (such as anesthesia or x-rays)
associated with the proposed Medicare Part A or Part B procedures and
that those proposals also be shared publicly for public comment and
possible inclusion.
Response: We appreciate commenters' suggestions regarding the
review process for the addition of possible clinical scenarios. We
agree with the commenters that the process should be consistent and
that supporting materials for proposed clinical scenarios should be
evidence-based, all of which should be partnered with the opportunity
for interested party feedback regarding possible future updates to the
policies for Medicare Parts A and B payment for dental services. We
seek to engage with interested parties and collaborate with respect to
identifying those medical services that include dental services that
are inextricably linked to, and substantially related and integral to
the clinical success of the covered medical service. Additionally, we
agree that ancillary or related services should be considered when
evaluating a medical scenario for inclusion in this policy.
We appreciate the commenters' recommendation that CMS establish and
then leverage an expert advisory panel for the review of clinical
scenarios for future updates. We also agree with commenters that
thoughtful engagement with interested parties is important to further
clarifying the link between dental services and certain covered medical
services. We therefore believe that it is important to create a process
that can be implemented in a time-sensitive fashion, which would
facilitate and expedite the identification of medical services that are
potentially inextricably linked to corresponding dental services
because such dental services are substantially related and integral to
the clinical success of that covered medical service.
We agree with commenters that public feedback is important,
especially when considering Medicare payment for critical treatments
that may benefit the clinical outcomes for certain covered medical
services for Medicare beneficiaries. We believe that discussing the
recommendations we are considering further in the course of our annual
rulemaking will allow the public to comment and submit further medical
evidence to assist us in evaluating whether the standard of care for
that medical service is such that one would not proceed with the
medical procedure or service without performing the dental service(s),
because the covered medical services would or could be significantly
and materially compromised, such that clinical outcomes could be
compromised absent the provision of the inextricably-linked dental
services, or where dental services are a clinical prerequisite to
proceeding with the primary medical procedure and/or treatment. This
would also allow the public to comment on whether the particular dental
services should or should not be subject to the general preclusion on
payment for dental services under section 1862(a)(12) of the Act,
because they are or are not inextricably linked to, and substantially
related and integral to the clinical success of, covered medical
services; and provide the medical evidence to support their position.
We have an existing process within the framework of annual PFS
rulemaking, which we believe we should continue to leverage to allow
for this level of public engagement. We believe that this would be an
efficient approach and would provide an immediately achievable avenue
for submissions from the public, and review and analysis by CMS and the
public.
Therefore, we are finalizing an annual process for the review of
public nominations. We will use the PFS annual rulemaking process to
determine whether certain dental services should be considered not
subject to the general preclusion on payment for dental services under
section 1862(a)(12) of the Act because they are inextricably linked to,
and substantially related and integral to the clinical success of,
other covered medical services. This process serves to facilitate the
codification and clarification of our existing policy as described in
section II.L. of this final rule, as a nomination process that will
allow us to evaluate additional examples under which payment could be
made under Medicare Part A and Part B for dental services.
The establishment of an advisory panel would require significant
time and procedural effort per statute and regulation.\128\ \129\ At
this time, we will not be implementing an advisory panel, but
appreciate this recommendation.
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\128\ https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/statutes-and-related-legislation.
\129\ https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/faca-final-rule-2001.
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The public is encouraged to engage with us regularly to submit
clinical scenarios for consideration. In order for public
recommendations to be potentially considered within the annual PFS
rulemaking cycle, interested parties should submit evidence and
nominations for consideration by
[[Page 69686]]
February 10th of each calendar year. This date is consistent with the
date used for submission of other information to CMS for consideration
in the upcoming rulemaking process, such as nominations for misvalued
codes, additions to the telehealth services list, and submission of
invoices for pricing direct PE supply and equipment items. We will
evaluate the supporting documentation and decide whether the medical
services should be further considered as not subject to the general
preclusion on payment for dental services under section 1862(a)(12) of
the Act during that calendar year's rule-making cycle. For example,
information received by February 10, 2023, would be reviewed for
consideration and potential inclusion within the CY 2024 PFS proposed
rule. Submissions received after February 10th will still be reviewed,
but may be considered in subsequent rulemaking instead of that calendar
year's rulemaking cycle.
We note that we may identify additional clinical scenarios for
review based on our review of public submissions or identified through
our own internal research and if so, would make those clinical
scenarios available for public review through the annual PFS rulemaking
cycle.
We agree with commenters that clinical evidence should be
thoughtfully considered and evaluated by interested parties. As such,
we encourage stakeholders who believe they have identified dental
services that are inextricably linked to, and substantially related and
integral to the clinical success of, other covered medical services to
nominate these scenarios, supported by documentation, through the
public process. Commenters are also welcome to submit additional
information regarding some of the clinical scenarios presented, but not
included in a finalized policy, in this final rule, including
immunosuppressant therapies, joint replacement surgeries, and
management of chronic conditions such as diabetes, and other surgical
procedures. We also encourage interested parties to submit to us
suggestions for further clarification of current policy, such as but
not limited to, recommendations on implementation, payment, and
provider enrollment.
We agree with commenters that we should thoroughly consider the
clinical evidence to review whether there is an inextricable link
between certain dental and medical services. As such, accompanying
documentation should be provided to support or refute the link between
certain medical and dental services. Specifically, this medical
evidence should support that the provision of certain dental services
leads to improved healing, improved quality of surgery, and the reduced
likelihood of readmission and/or surgical revisions, because an
infection has interfered with the integration of the implant and
interfered with the implant to the skeletal structure. We expect
evidence to be clinically meaningful and demonstrate that the dental
services result in a material difference in terms of the clinical
outcomes and success of the procedure such that the dental services are
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services, and
therefore not subject to the statutory payment preclusion in section
1862(a)(12) of the Act. The clinical evidence should be compelling to
support that certain dental services would result in clinically
significant improvements in quality and safety outcomes, for example,
fewer revisions, fewer readmissions, more rapid healing, quicker
discharge, quicker rehabilitation for the patient.
This evidence should include at least one of the following: (1)
relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care; (2) evidence of clinical guidelines or generally accepted
standards of care for the suggested clinical scenario; (3) other
ancillary services that may be integral to the covered medical
services; and/or (4) other supporting documentation to justify the
inclusion of the proposed medical clinical scenario requiring dental
services.
Interested parties are encouraged to submit their recommendations
by February 10th of a calendar year via email at
[email protected] for consideration and
potential inclusion within the PFS proposed rule for the subsequent
calendar year. Interested parties should include the words `dental
recommendations for CY 2XXX review' in the subject line of their
submission email to facilitate processing (CY 2XXX should refer to the
rulemaking cycle for the year). We note that we may also consider
proposals submitted as public comments during the comment period
following the publication of the PFS proposed rule.
Final Action: After consideration of the comments received, and for
the reasons previously discussed, we are finalizing our proposals,
effective CY 2023, to: (1) clarify our interpretation of section
1862(a)(12) of the Act and codify certain of current Medicare FFS
payment policies for medically necessary dental services; and (2) our
proposal that payment may be made for other dental services, such as
dental or oral examinations, including necessary treatment, performed
as part of a comprehensive workup prior to organ transplantations
(including hematopoietic stem cell and bone marrow transplantations),
or prior to cardiac valve replacement or valvuloplasty procedures, that
are similarly inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services. We are also finalizing for CY 2024 that Medicare Parts A and
B payment may be made for dental services, such as dental or oral
examinations, including necessary treatment, performed as part of a
comprehensive workup prior to treatment for head and neck cancers, for
which we stated we may consider finalizing in this final rule, because
those services are similarly inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services. We are not finalizing, at this time, that payment may
be made under Medicare Parts A and B for dental services prior to the
initiation of immunosuppressant therapy, joint replacement procedures
or other surgical procedures, for which we stated we may consider
finalizing in this final rule. We remain committed to exploring the
inextricable link between dental and medical services associated with
immunosuppressant therapy, joint replacement surgeries and other
surgical procedures, and we will continue to review the clinical
evidence to determine whether the services are inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services and would welcome continued
engagement from the public. We will address additional clinical
scenarios involving dental services, such as services inextricably
linked and integral to particular kinds of treatments for
immunocompromised patients, in 2024 rulemaking.
Effective CY 2023, we are finalizing the establishment of a process
to identify for our consideration and review submissions of additional
dental services that are inextricably linked and substantially related
and integral to the clinical success of other covered medical services.
We note that we stated in this proposed rule that we may consider
finalizing such process in this final rule after a review of the
commenters received. Specifically, we
[[Page 69687]]
are finalizing an annual process for the review of public nominations
of dental services that the public is recommending not be considered
subject to the general preclusion on payment for dental services under
section 1862(a)(12) of the Act. Interested parties should submit
evidence and nominations via email at
[email protected], and should include the words
dental recommendations for CY 2XXX review' in the subject line of their
submission email to facilitate processing (CY 2XXX should refer to the
rulemaking cycle for the year), by February 10th of each calendar year
in order for these recommendations to be potentially considered within
the annual PFS rulemaking cycle. Recommendations may also make
suggestions for clarifications for this policy generally, such as but
not limited to, recommendations on implementation, payment, and
provider enrollment.
We expect accompanying documentation to be provided. The medical
evidence should support or refute whether the provision of certain
dental services is inextricably linked to, and substantially related
and integral to the clinical success of, certain other covered medical
services. This evidence should include any of the following: (1)
relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care; (2) evidence of clinical guidelines or generally accepted
standards of care for the suggested clinical scenario; (3) other
ancillary services that may be integral to the covered medical
services; and/or (4) other supporting documentation to justify the
inclusion of the proposed medical clinical scenario requiring dental
services.
We are finalizing our proposed amendments to the regulations at
Sec. 411.15(i). First, we are finalizing our proposed amendments,
without modifications, to our existing regulations at Sec.
411.15(i)(1) and (2) that dental services are not covered in connection
with the care, treatment, filling, removal, or replacement of teeth, or
structures directly supporting the teeth, with the exception for dental
services for inpatient hospital services in connection with such dental
procedures when hospitalization is required because of--
The individual's underlying medical condition and clinical
status; or
The severity of the dental procedures.
Second, we are finalizing, with modifications, to the regulations
at Sec. 411.15(i), to include examples of services for which payment
can be made under Medicare Parts A and B on that basis. Specifically,
we are amending Sec. 411.15(i)(3)(i), to allow for payment under
Medicare Part A and Part B for dental services, furnished in an
inpatient or outpatient setting, that are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services, including, but not limited to: (1) the
dental or oral examination as part of a comprehensive workup prior to a
Medicare covered organ transplant, cardiac valve replacement, or
valvuloplasty procedure; (2) the necessary dental treatments and
diagnostics to eliminate the oral or dental infections found during a
dental or oral examination as part of a comprehensive workup prior to,
and contemporaneously with, the organ transplant, cardiac valve
replacement, or valvuloplasty procedure; (3) reconstruction of a ridge
when it is performed as a result of, and at the same time as, the
surgical removal of a tumor; (4) the stabilization or immobilization of
teeth in connection with the reduction of a jaw fracture and dental
splints only when used in conjunction with covered treatment of a
covered medical condition such as dislocated jaw joints; and (5) the
extraction of teeth to prepare the jaw for radiation treatment of
neoplastic disease; and We will make conforming changes to the MBP
Manual to reflect these changes or clarifications, and to remove any
text that is no longer applicable.
We will make amendments to Sec. 411.15(i)(3)(i)(A) for CY 2024 to
specify that payment under Medicare Parts A and B can be made for an
oral or dental examination, and medically necessary diagnostic and
treatment services to eliminate an oral or dental infection, prior to,
or contemporaneously with, treatment for head and neck cancers. These
amendments to Sec. 411.15(i)(3)(i)(A) would conform with the policy
finalized in this rule for CY 2024, as clarified by any further
rulemaking, and add to the regulation as an example of dental services
for which payment can be made under Medicare Parts A and B dental
services furnished prior to and contemporaneously with the treatment
for head and neck cancers.
We are also finalizing our proposal, without modification, to amend
our regulation at Sec. 411.15(i)(3)(i) to provide that payment can be
made for dental services provided in conjunction with medical services
that are inextricably linked to, and substantially related and integral
to the clinical success of, covered medical services, such as X-rays,
administration of anesthesia, and use of the operating room.
Additionally, we are finalizing with modification the removal the word
``other'' from the description of ``ancillary services and other
supplies furnished incident to covered dental services'' to improve
clarity and to avoid suggesting that ``services'' are ``supplies.''
This modification does not modify the proposed or final policy.
Medicare will make payment under Parts A and B for these dental
services that are determined to be inextricably linked to the clinical
success of an otherwise covered medical service, and therefore, are
instead substantially related and integral to that primary medical
service, prior to or contemporaneously with certain covered medical
services. No payment is made for dental services when an excluded
service is the primary procedure involved. We continue to contractor
price the dental services for which payment is made currently, and for
the dental services that can be made under the amendments to Sec.
411.15(i)(3) for CY 2023 and CY 2024, and until we have further data.
We will update the applicable payment files so that services may be
furnished and paid under the applicable payment system.
We will make payment when a doctor of dental medicine or dental
surgery (referred to as a dentist) furnishes dental services that are
an integral part of the covered primary procedure or service furnished
by another physician, or non-physician practitioner, treating the
primary medical illness. If there is no exchange of information, or
integration, between the medical professional (physician or other non-
physician practitioner) in regard to the primary medical service and
the dentist in regard to the dental services, then there would not be
an inextricable link between the dental and covered medical service
within the meaning of our regulation at Sec. 411.15(i)(3). As such,
the services would be in connection with the care, treatment, filling,
removal, or replacement of teeth or structures directly supporting
teeth within the meaning of section 1862(a)(12) of the Act. Without
both integration between the Medicare enrolled medical and dental
professional, and the inextricable link between the dental and covered
medical services, dental services fall outside of the Medicare Part B
benefit as they would be in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting teeth within the meaning of section 1862(a)(12) of the
[[Page 69688]]
Act; though they may be covered by types of supplemental health or
dental coverage.
Payment may also be made for services and supplies furnished
incident to those dental services furnished by the dentist or other
physician or practitioner, and for other ancillary services integral to
the dental services. Medicare payment could be made for services
furnished incident to the professional medical or dental services by
auxiliary personnel, such as a dental hygienist, dental therapist, or
registered nurse who is under the direct supervision of the furnishing
dentist or other physician or practitioner, if they meet the
requirements for ``incident to'' services as described in Sec. 410.26
of our regulations.
The finalized policies outlined in this section of this final rule
would not prevent a MAC from making a determination that payment can be
made for dental services in other circumstances not specifically
addressed as examples within this final rule and the finalized
amendments to Sec. 411.15(i). MACs may continue to determine on a
claim-by-claim basis whether a patient's clinical circumstances do or
do not fit within the terms of the preclusion or exception specified in
section 1862(a)(12) of the Act and Sec. 411.15(i).
Lastly, we may provide additional guidance or future rulemaking
regarding these policies as determined appropriate or necessary. We
encourage continued engagement through the process as finalized under
section II.L.2.c.ii. of this final rule so that we may consider
revisions to this policy potentially in the future.
M. Rebasing and Revising the Medicare Economic Index (MEI)
1. Background
The Medicare Economic Index (MEI) is authorized under section
1842(b)(3) of the Act, which relates to the reasonable charge-based
payment methodology that was in place for physicians' services prior to
the PFS implementation. That section states that prevailing charge
levels beginning after June 30, 1973, may not exceed the level from the
previous year except to the extent that the Secretary finds, on the
basis of appropriate economic index data, that such higher level is
justified by year-to-year economic changes. CMS began calculating the
MEI for this purpose on July 1, 1975 and continues to do so today for
several statutory and other purposes. The MEI reflects the weighted-
average annual price change for various inputs involved in furnishing
physicians' services.
The MEI is a fixed-weight input price index comprised of two broad
categories: (1) Physicians' own time (compensation); and (2)
physicians' practice expense (PE). Additionally, it includes an
adjustment for the change in economy-wide, private nonfarm business
total factor productivity (previously referred to as multifactor
productivity).\130\ The U.S. Department of Labor's Bureau of Labor
Statistics (BLS) publishes the official measures of productivity for
the U.S. economy. We note that previously the productivity measure
referenced in section 1886(b)(3)(B)(xi)(II) of the Act was published by
BLS as private nonfarm business multifactor productivity. Beginning
with the November 18, 2021 release of productivity data, BLS replaced
the term multifactor productivity (MFP) with total factor productivity
(TFP). BLS noted that this is a change in terminology only and will not
affect the data or methodology.
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\130\ https://www.bls.gov/news.release/prod5.nr0.htm.
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The current form of the MEI was described in the November 25, 1992
Federal Register (57 FR 55896) and was based in part on the
recommendations of a Congressionally-mandated meeting of experts held
in March 1987. Since that time, the MEI has been updated or revised on
five instances. First, the MEI was rebased in 1998 (63 FR 58845), which
moved the cost structure of the index from 1992 data to 1996 data.
Second, the methodology for the productivity adjustment was revised in
the CY 2003 PFS final rule with comment period (67 FR 80019) to reflect
the percentage change in the 10-year moving average of economy-wide
private nonfarm business total factor (multifactor) productivity.
Third, the MEI was rebased in the CY 2004 PFS final rule with comment
period (68 FR 63239), which moved the cost structure of the index from
1996 data to 2000 data. Fourth, the MEI was rebased in 2011 (75 FR
73262), which moved the cost structure of the index from 2000 data to
2006 data. Subsequently, in the CY 2014 PFS final rule with comment
period (78 FR 74264), the MEI cost share weights were revised based on
recommendations from the MEI technical advisory panel (MEI-TAP). From
May 2012 through September 2012, the MEI Technical Advisory Panel
conducted a technical review of the MEI, including analyses of the
inputs, input weights, price-measurement proxies, and productivity
adjustment. Details regarding the Panel's work and documents such as
transcripts, meeting summaries, presentations, and the final report
with recommendations to the Secretary of Health and Human Services are
available at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEITAP and in the CY 2014 PFS proposed rule (78 FR 43311) which
provides details related to how the MEI TAP panel recommendations were
implemented into the revised 2006-based MEI. The current 2006-based MEI
relies on data collected from the American Medical Association (AMA)
for self-employed physicians from the Physician Practice Information
Survey (PPIS). The AMA has not fielded another survey since that 2006
data collection effort and so the MEI has continued to be based on
2006-based costs. In its August 28, 2012 report, the MEI-TAP expressed
concern regarding the representativeness and availability of data to
support the MEI and provided two recommendations regarding the data
sources to update the MEI in the future. Recommendation 2.1 stated that
CMS should research whether using self-employed physician data for the
MEI cost weights continues to be the most appropriate approach given
the trend toward larger, physician-owned practices, as well as the
movement from physician-owned practices toward hospital-owned
practices. Recommendation 2.2 stated that CMS should scan for and
research additional data sources that may allow for more frequent
updates to the MEI's cost categories and their respective weights.\131\
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\131\ The MEI-TAP's final report, including all findings and
recommendations, are available at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEITAP.
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Updates to the PFS conversion factor (CF) were previously
calculated based on a prescribed statutory formula that used a
combination of the MEI and a ``sustainable growth rate''; for details
about this formula, we refer readers to the CY 2015 PFS final rule with
comment period (79 FR 67741 through 67742). Section 101 of the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 115-05,
April 16, 2015) repealed the previous statutory update formula and
specified the update adjustment factors for calendar years 2015 and
beyond. Therefore, effective beginning with CY 2015, the MEI was no
longer used in calculating the annual update to the PFS CF. The annual
growth in the MEI continues to be used to update the following: the
Medicare telehealth originating site facility fee under section
1834(m)(2)(B)(i) of the Act, the KX
[[Page 69689]]
Modifier Thresholds (formerly the therapy caps) under section
1833(g)(2) of the Act, targeted medical review (MR) threshold amounts
(beginning in 2029) under section 1833(g)(7)(B)(ii) of the Act, Rural
Health Clinic Payment Limits under section 1833(f)(2) of the Act, and
the annual update to the non-drug portion of the Opioid Treatment
Program payment as finalized in the CY 2020 PFS final rule (84 FR 62668
and 62669).
While the MEI annual percentage change increase is not directly
used in determining the update to the PFS CF, the MEI cost weights have
historically been used to update the GPCI cost share weights to weigh
the four components of the practice expense GPCI (employee
compensation, office rent, purchased services, and medical equipment,
supplies, and other miscellaneous expenses), as discussed in detail in
section II.G. of the final rule, and to recalibrate the relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs, as discussed in section II.B.
and VI. of the final rule. The most recent recalibration was done for
the CY 2014 RVUs when the MEI was last updated. As described in the CY
2014 PFS final rule (78 FR 74236 through 74237, and 74241), in steps 3
and 10, we adjusted the aggregate pool of PE costs in proportion to the
change in the PE share in the revised MEI cost share weights. These
adjustments were consistent with our longstanding practice to make
adjustments to match the RVUs for the PFS components with the MEI cost
share weights for the components, including the adjustments described
in the CY 1999 PFS final rule (63 FR 58829), CY 2004 PFS final rule (68
FR 63246 and 63247), and CY 2011 PFS final rule (75 FR 73275).
Therefore, as discussed in the CY 2023 PFS proposed rule (87 FR
460462), we believe that the MEI cost weights need to be updated to
reflect more current market conditions faced by physicians in
furnishing physicians' services, but note that we are finalizing to
delay the implementation of the rebased and revised MEI cost weights
for both CY 2023 PFS ratesetting and the finalized CY 2023 GPCIs. We
explained that we believe that doing so will allow interested parties
the opportunity to review and comment on the proposed rebased and
revised MEI cost share weights discussed in section II.M. of the
proposed rule and their potential impacts before we use such rebased
and revised MEI cost share weights for purposes of proportioning the
work, PE, and MP RVU pools in PFS ratesetting and updating the GPCIs.
We refer readers to our discussion about using the proposed rebased and
revised MEI cost share weights for purposes of proportioning the work,
PE, and MP RVU pools in PFS ratesetting and to update the GPCIs for CY
2023 in sections II.B. and VI. of this final rule. In those sections,
we discuss our considerations for updating the MEI cost share weights
for the RVUs and the GPCIs and the potential redistributive impact that
making such a change would have on PFS payments. We solicited comments
on the proposed delay and potential use of the proposed updated MEI
cost weights in future years to recalibrate the RVU shares and to
update the GPCI cost share weights, which were last realigned to the
revised MEI weights in the CY 2014 PFS final rule (78 FR 74380 through
74391).
This section of the final rule provides an overview of the
methodology for updating the MEI cost share weights and the results of
the rebasing and revising of the MEI for purposes of estimating annual
input price inflation for physician services, used for purposes of
updating payments outside of the PFS ratesetting. We note that specific
comments relating to the delayed implementation of the MEI in PFS
ratesetting and CY 2023 GPCIs are discussed in sections II.B. and VI.
of this final rule.
The terms ``rebasing'' and ``revising,'' while often used
interchangeably, actually denote different activities. Rebasing refers
to moving the base year for the structure of costs of an input price
index while revising relates to other types of changes such as using
different data sources, cost categories, or price proxies in the input
price index. Effective with this CY 2023 PFS rulemaking cycle, we
proposed to rebase and revise the MEI based on a methodology that uses
publicly available data sources for input costs that represent all
types of physician practice ownership; that is, not limited to only
self-employed physicians. We detailed the proposals regarding the
derivation of the cost categories and associated cost share weights,
selection of the price proxies in the MEI, and the results of the
proposed 2017-based MEI as compared to the current 2006-based MEI in
the proposed rule as well as below.
2. Developing the Cost Weights for Use in the MEI
The 2006-based MEI was last rebased in the CY 2011 PFS final rule
with comment period (75 FR 73262 through 73275) and subsequently
revised in the CY 2014 PFS final rule with comment period (78 FR 74264
through 74278). The proposed 2017-based MEI cost weights are derived
predominantly from the annual expense data from the U.S. Census
Bureau's Services Annual Survey (SAS, https://www.census.gov/programs-surveys/sas.html). Other data sources that were considered and analyzed
as potential sources of expense data for Physician Offices included the
BEA Benchmark Input-Output data, the Internal Revenue Services (IRS)
Statistics of Income data for sole proprietors, and the Medical Group
Management Association (MGMA) cost and revenue data. While each of
these data sources provided information on physician input price
expenses, we found the SAS data to be the most technically appropriate
data source available based on various factors including public
availability, level of detail of expense categories, and sample
representativeness of the universe. The SAS data are publicly available
data that provide annual receipts estimates for the service industries.
Collected data include sources of revenue and expenses by type for
selected industries and selected industry-specific items. Specifically,
we proposed to use the 2017 SAS data from Table 5, Estimated Selected
Expenses for Employer Firms for NAICS 6211 (Office of Physicians). The
survey data collection in 2018 and 2019 were scaled back and therefore,
data by expense category was limited for those years in comparison to
the 2017 data. For example, the SAS expense data for lease and rental
payments, professional and technical services, repair and maintenance
services, and detailed utility costs were unavailable in 2018 and 2019.
The 2020 data included a return to the more comprehensive collection of
expense data; however, the presence of the PHE for COVID-19 raised
questions regarding the representativeness and stability of the data
given impacts on the utilization of physicians' services and associated
expenses. Therefore, we proposed to use the 2017 SAS data for the
proposed 2017-based MEI because it was the most recently available and
complete data available at the time of rulemaking.
We proposed to supplement the 2017 SAS expense data by using
several data sources for further disaggregation of compensation costs
and all other residual costs, including the 2017 Bureau of Labor
Statistics (BLS) Occupational Employment and Wage Statistics (OEWS),
the 2012 Bureau of Economic Analysis (BEA) Benchmark Input-Output data
(I/O), the 2006 AMA PPIS, and the 2020 AMA Physician
[[Page 69690]]
Practice Benchmark Survey. Table 37 lists the set of mutually exclusive
and exhaustive cost categories and weights for the proposed 2017-based
MEI compared to the 2006-based MEI.
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Total costs equal the sum of the costs for Physician Compensation
and Practice Expenses. The development of the cost weights for each
cost category in the proposed 2017-based MEI is described, in detail,
as follows.
a. Physician's Compensation
The component of the MEI that reflects physician work is
represented by the estimated portion of compensation expenses
attributable to physicians. The proposed 2017 cost weight associated
with the physician's work (otherwise referred to as the Physician
Compensation cost weight) is based on the estimated share of 2017 SAS
expenses for total compensation associated with physician compensation.
Since the compensation expense in the SAS data is only reported as an
aggregate for all employees, we proposed to split the compensation
expenses between physicians (including non-physician practitioners that
can bill independently such as nurse practitioners (NPs), physician
assistants (PAs), and other clinical personnel) and all other workers
using the following process.
Step 1: Total compensation costs are calculated by summing the
reported expenses in the SAS for gross annual payroll, employer costs
for fringe benefits (including health insurance, defined benefit, and
defined contribution plans, payroll taxes, employer-paid insurance
premiums, and all other benefits), and temporary staff and leased
employees as reported in the 2017 SAS data for NAICS 6211 (Office of
Physicians).
Step 2: Determine the ratio of physician (including non-physician
practitioners that can bill independently such as NPs, PAs, and other
clinical personnel) wage costs to total wage costs. This ratio is
calculated using data from the Bureau of Labor Statistics (BLS)
Occupational Employment and Wage Statistics (OEWS) May 2017 National
Industry-Specific Occupational Employment and Wage Estimates for
Offices of Physicians (NAICS 6211). This data reports the number of
employees by occupational category based on the Standard Occupational
Classification System (SOC) and the mean hourly wage for each
occupation. For each occupation, we multiplied the
[[Page 69691]]
number of employees by the mean hourly wage to estimate the total mean
hourly wage expense. The sum of expenses for each occupation category
represents total mean hourly wage expenses for all occupations in NAICS
6211. Then to derive the total mean hourly wage expenses for physicians
(including non-physician practitioners that can bill independently such
as NPs, PAs, and other clinical personnel) we proposed to sum the
expenses for the following occupations: Physicians and Surgeons (29-
1060); Chiropractor (29-1011); Optometrist (29-1041); Podiatrist (29-
1081); Physical Therapist (29-1123); Dieticians & Nutritionists (29-
1031); Physician Assistants (29-1071); Nurse Practitioners (29-1171);
and All Other Diagnosing & Treating Occupations (29-11XX)), which
includes compensation costs for Registered Nurses (29-1141). The ratio
of physician total mean hourly wage costs to total mean hourly wage
costs is 63.2 percent.
Step 3: We proposed to multiply the total compensation expenses
from Step 1 by the ratio determined in Step 2 to derive estimated
Employed Physician Compensation Expenses, which in 2017 were estimated
to account for 42.4 percent of total costs.
Next, since the expenses estimated above reflect only employed
physician compensation, we proposed to add an estimate of compensation
costs to account for physician practice owners that are not classified
as employees but instead would be included in the net income of the
practice. The net income physician compensation costs are estimated by
the following methodology. This amount is determined in three steps:
Step 1: We proposed to subtract total expenses from total revenue
as reported in the 2017 SAS data for NAICS 6211.
Step 2: We estimated the share of owners versus employees of
physician practices for 2017 based on the average share of ``owners''
for 2016 and 2018 as reported in Exhibit 1 of the 2020 AMA Physician
Practice Benchmark Survey. This estimated share for 2017 is 46.5
percent.
Step 3: We multiplied the share determined in step 2 by the amount
determined in step 1, which represents the estimated expenses for net
income for owners of physician practices and is 4.845 percent of total
costs in 2017.
The proposed aggregate 2017-based Physician Compensation cost
weight is the sum of the Employed Physician Compensation cost weight
(42.416 percent) and Estimated Net Income for Physician Practice Owners
cost weight (4.845 percent), or 47.261 percent. By comparison, the
2006-based Physician Compensation cost weight was 50.866 percent and
reflects the net income for self-employed physicians and the expenses
for non-physician clinical staff that can bill Medicare independently.
The proposed 2017-based MEI cost weight for Physician Compensation is
3.6 percentage points lower than the 2006-based MEI cost weight. This
difference is due to two key factors: (1) any changes that occurred in
the cost to provide physician services between 2006 and 2017, and (2)
the SAS data reflects relative costs for all physician ownership
practices while the 2006 AMA PPIS data reflected relative costs only
for self-employed physician practices.
We proposed to split the Physician Compensation cost weight into
two cost categories: Physician Wages and Salaries, and Physician
Benefits. The proposed Physician Wages and Salaries cost weight is
calculated by multiplying the total Physician Compensation weight by
the ratio of the gross payroll to the sum of gross payroll and
employer's cost for fringe benefits in the 2017 SAS data, which is 83
percent. The proposed Physician Benefits cost weight is calculated by
multiplying the total physician compensation weight by the ratio of the
employee benefits to the sum of gross payroll and employer's cost for
fringe benefits in the 2017 SAS data, which is 17 percent. As a result,
the proposed Physician Wages and Salaries cost weight is 39.226 percent
and the proposed Physician Benefits cost weight is 8.034 percent in the
2017-based MEI.
b. Practice Expenses
The Practice Expenses cost weight reflects all remaining operating
costs other than physician compensation. We proposed to determine the
remaining Practice Expense cost weights in the 2017-based MEI using the
2017 SAS Expense data for NAICS 6211 expressed as a percentage of total
costs. The explanations for the derivation of the individual cost
weights under Practice Expenses are detailed below.
(1) Non-Physician Compensation
We proposed to estimate the cost weight for Non-physician
Compensation using the 2017 SAS data for these expenses. As mentioned
previously, since the compensation expenses in the SAS data are only
reported as an aggregate for all employees, we proposed to multiply the
2017 SAS total compensation expenses for NAICS 6211 by 36.8 percent,
which is the residual of the 63.2-percent share determined for
physicians (including non-physician practitioners that can bill
independently such as NPs, PAs, and other clinical personnel).
Then, we proposed to multiply the total compensation expenses by
the ratio of non-physician compensation expenses to total compensation
expenses. This results in the proposed Non-physician Compensation cost
weight of 24.716 percent in the proposed 2017-based MEI.
Next, we proposed to split the Non-physician Compensation cost
weight into two cost categories: Non-physician Wages and Salaries, and
Non-physician Benefits. The Non-physician Wages and Salaries cost
weight is calculated by multiplying the total Non-physician
Compensation cost weight by the ratio of the gross payroll to the sum
of gross payroll and employer's expense for fringe benefits in the 2017
SAS data, which is 83 percent. The Non-physician Benefits cost weight
is calculated by multiplying the total Non-physician Compensation
weight by the ratio of the employee benefits to the sum of gross
payroll and employer's expenses for fringe benefits in the 2017 SAS
data, which is 17 percent. As a result, the proposed Non-physician
Wages and Salaries cost weight is 20.514 percent in the proposed 2017-
based MEI and the proposed Non-physician Benefits cost weight is 4.202
percent. For comparison purposes, the 2006-based MEI cost weights are
11.885 percent and 4.668 percent, respectively. We also proposed to
disaggregate the Non-physician Wages and Salaries cost weight into two
categories: (1) Health-related, non-physician; and (2) Non-health, non-
physician Wages and Salaries.
Of the 36.8 percent of total SAS compensation costs associated with
non-physicians, 14.7 percentage points are determined to be associated
with Health-related, non-physician Wages and Salaries. This percentage
reflects the ratio of mean hourly wages to total mean hourly wages from
the 2017 OEWS data for the following occupations: Health Technologists
and Technicians (29-2000); Other Healthcare Practitioners and Technical
(29-9000); and Healthcare Support (31-0000). Applying this share (about
40 percent) to the non-physician wages cost weight results in a
proposed weight of 8.208 percent for the health-related, non-physician
Wages and Salaries cost weight for the proposed 2017-based MEI.
The remaining share of non-physician compensation costs are
associated with Non-health, non-physician Wages and Salaries (22.1
percentage points of the 36.8 percent). This percentage reflects the
ratio of mean hourly wages to total
[[Page 69692]]
mean hourly wages from the 2017 OEWS data for the following
occupations: Management (11-0000); Business and Financial Operations
(13-0000); Computer and Mathematical (15-0000); Architecture and
Engineering (17-0000); Life, Physical, and Social Science (19-0000);
Community and Social Service (21-0000); Legal (23-0000); Education,
Training, and Library (25-0000); Arts, Design, Entertainment, Sports,
and Media (27-0000); Protective Service (33-0000); Food Preparation and
Serving Related (35-0000); Building and Grounds Cleaning and
Maintenance (37-0000); Personal Care and Service (39-0000); Sales and
Related (41-0000); Office and Administrative Support (43-0000);
Construction and Extraction (47-0000); Installation, Maintenance, and
Repair (49-0000); Production (51-0000); and Transportation and Material
Moving (53-0000). Applying this share (about 60 percent) to the non-
physician wages cost weight results in a proposed weight of 12.306
percent for the non-health, non-physician Wages and Salaries cost
weight for the proposed 2017-based MEI.
Next, since the non-health, non-physician wages represent various
types of occupations that may experience different wage inflation
pressures, we proposed to disaggregate the non-health, non-physician
Wages and Salaries cost weight of 12.306 percent into four occupational
subcategories. To arrive at a distribution for these separate
occupational categories (Professional & Related (P&R) workers,
Managers, Clerical workers, and Service workers), we determined an
estimate of annual earnings for each using the Standard Occupational
Classification (SOC) system. The professional and related wages &
salaries consist of the following occupational categories: Business and
Financial Operations (13-0000); Computer and Mathematical (15-0000);
Architecture and Engineering (17-0000); and Life, Physical, and Social
Science (19-0000). The Clerical wages & salaries consist of the
occupational category Office & Administrative Support (43-0000). The
Services wages & salaries consist of the following occupational
categories: Community and Social Service (21-0000); Arts, Design,
Entertainment, Sports, and Media (25-0000); Protective Service (33-
0000); Food Preparation and Serving Related (35-0000); Building and
Grounds Cleaning and Maintenance (37-0000); Personal Care and Service
(39-0000); Sales and Related (41-0000); Construction and Extraction
(47-0000); Installation, Maintenance, and Repair (49-0000); Production
(51-0000); and Transportation and Material Moving (53-0000).
The non-health, non-physician Wages and Salaries cost weight of
12.306 percent is multiplied by the relative share of each category to
arrive at the detailed distribution. The occupational distribution in
the proposed 2017-based MEI, as well as the distribution for the 2006-
based MEI, is presented in Table 38.
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(2) Other Practice Expenses
We proposed that the remaining aggregate Other Practice Expenses
would be derived using the 2017 NAICS 6211 SAS expense data and
calculated as the sum of the expenses for the detailed categories
expressed as a percentage of total expenses. The aggregate Other
Practice Expenses include all SAS expenses other than gross annual
payroll, fringe benefits, and temporary staff and leased employee
expenses. Additionally, we proposed to remove the estimated expenses
for drugs and separately billable supplies (which are paid outside of
the PFS system) from total expenses in order to be consistent with the
PFS. The Other Practice Expenses share of total costs in the proposed
2017-based MEI is 28.023 percent compared to a cost weight of 32.582
percent in the 2006-based MEI.
We further proposed to use the 2017 SAS data for NAICS 6211 to
disaggregate the Other Practice Expenses into the following ten cost
categories: Utilities; All Other Products; Telephone; Administrative
Support & Waste Services; All Other Services; Professional, Scientific,
and Technical; Fixed Capital; Moveable Capital; Professional Liability
Insurance; and Medical Supplies. Table 39 shows the 10 detailed cost
weights for the Other Practice Expenses for the 2017-based MEI, which
is 6 fewer categories than the 2006-based MEI. The major differences
are: (1) we proposed to have one cost category for All Other Products
in the proposed 2017-based MEI instead of having separate cost
categories for Chemicals, Paper, Rubber and Plastics, and Other
Miscellaneous Products as done for the 2006-based MEI, (2) we proposed
to eliminate the separate cost category for Postage as the cost weight
was small (less than 0.2 percentage point) and include the expenses for
postage in the proposed All Other Products cost weight, and (3) we
proposed to eliminate the cost category for Medical Equipment as the
cost weight for the Moveable Capital in the proposed 2017-based MEI
includes the expenses for all types of machinery and equipment,
including medical equipment; we do not have a data source available to
split the expenses between Medical Equipment and All Other Equipment in
the SAS or I-O data.
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As previously mentioned, we proposed to make one adjustment to the
medical supplies expenses as reported on the SAS data to exclude
estimated expenses associated with drugs and separately billable
supplies. We proposed to make this adjustment in order to exclude the
expenses that are paid outside of the PFS and to be consistent with the
expenses that were also excluded in the 2006-based MEI. Finally, we
proposed to use the BEA 2012--Benchmark I/O data aged to 2017 to
determine the split between All Other Products and All Other Services
that are captured in the residual ``all other expenses'' line in the
2017 SAS data. The BEA 2012--Benchmark I/O data can be accessed at
https://www.bea.gov/industry/input-output-accounts-data#supplemental-estimate-tables. We noted that this method of splitting residual
expenses is similar to the methodology used in the 2006-based MEI where
the 2002 Benchmark I/O data was aged to 2006 to further disaggregate
the residual expense from the AMA PPIS.
The following is a description of the types of expenses included in
each of the detailed categories under Other Practice Expenses:
(a) Utilities
The proposed weight for Utilities was calculated using the 2017 SAS
expense data expressed as a percentage of total expenses. Utilities
expenses are calculated as the sum of the expenses from SAS for: (1)
purchased electricity, (2) purchased fuels (except motor fuels), and
(3) water, sewer, refuse removal, and other utility payments. The SAS
survey questionnaire defines the purchased electricity expenses as
costs paid for electricity. The SAS survey questionnaire defines the
purchased fuels (except motor fuels) as the costs for fuel for heating,
power, or generating electricity (for example, natural gas, propane,
oil, coal). The SAS survey questionnaire defines the water, sewer,
refuse removal, and other utility payments as the costs for hazardous
waste removal. If the utility payments for any of these expenses are
included with lease and rental payments then they are captured in the
SAS question for lease and rental payments for land, building,
structures, storage spaces, or offices. The proposed cost weight for
Utilities in the 2017-based MEI is 0.366 percent.
(b) Telephone Services
The Telephone cost weight in the proposed 2017-based MEI includes
2017 SAS expenses reported for purchased communication services. The
SAS survey questionnaire defines purchased communication services as
telephone, cellular, and fax services; computer-related communications
(for example, internet, connectivity, online), and other wired and
wireless communication services. The proposed cost weight for Telephone
Services is 0.471 percent.
(c) All Other Products
The proposed cost weight for All Other Products for the proposed
2017-based MEI was calculated in two steps. First, all other operating
expenses are calculated as a percentage of total expenses from the 2017
SAS, which was 9.158 percent. The SAS survey questionnaire defines the
All Other operating expenses as operating expenses not reported or
captured by any other survey expense question or specifically excluded
in the general instructions. These expenses specifically excluded in
the general instructions are: transfers made within the company,
capitalized expenses, interest, bad debt, impairment, and income tax.
Second, All Other Products expenses are calculated as the estimated
percentage of expenses from SAS for all other operating expenses using
Benchmark I/O data. In order to split the aggregate all other operating
expenses, which reflects both products and services, we proposed to
rely on the 2012 Benchmark I/O data for NAICS 6211, Offices of
Physicians aged to 2017 for the NAICS categories that align with
expenses in the SAS all other operating expenses. The process for doing
this is explained step by step as follows:
Step 1: We crosswalked the NAICS categories in the 2012 Benchmark
I/O data to the expense questions in the 2017 SAS data. This process
allowed for all Benchmark I/O costs to be grouped into similar buckets
as the SAS Expenses as closely as possible.
[[Page 69694]]
Step 2: We aged the 2012 Benchmark I/O costs to 2017 for each of
the following major buckets of expenses: Physician Compensation, Non-
Physician Compensation, Capital-related expenses (fixed and moveable),
PLI, Professional Services, Other Products, Other Services, Utilities,
and Medical Supplies using the growth of the various price proxies used
for these cost categories in the 2006-based MEI.
Step 3: The share of each of the aged 2012 I/O expenses were
calculated as a percentage of the total aged 2012 I/O expenses. The
aged 2012 I/O categories of other products and other services were
estimated to account for about 9.6 percent of total costs. This share
is similar to the SAS residual cost share weight of 9.158 percent.
The following Table 40 shows the Benchmark I/O NAICS categories
that were crosswalked to the SAS all other operating expenses for all
other product expenses.
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Step 4: The share of expenses for the aged 2012 Benchmark I/O all
other products to the aged total all other operating expenses in the
Benchmark I/O were calculated. This resulted in products accounting for
22.4 percent
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and services accounting for 77.6 percent of the I/O expenses classified
as all other costs. We then multiplied the SAS all other operating
expenses (9.158 percent) by 22.4 percent to estimate expenses for the
all other products.
Step 5: Lastly, we divided the estimated all other products SAS
expenses by the total SAS expenses and the resulting proposed 2017-
based MEI cost weight for All Other Products is 2.055 percent.
(d) Administrative Support and Waste Services
The proposed weight for Administrative Support and Waste for the
proposed 2017-based MEI is based on a portion of the 2017 SAS all other
operating expenses (Residual). Similar to the methodology to calculate
the All Other Products cost weight we follow a similar process for the
Administrative Support & Waste Services cost weight and the All Other
Services cost weight discussed in the next section. First, we estimated
the total SAS residual expenses associated with other services by
multiplying the SAS all other operating expenses by 77.6 percent, or a
cost weight of 7.103 percent accounting for the SAS residual expenses
associated with services rather than products.
Next, we carved out a portion of these all other services expenses
that we identified as Administrative Support and Waste Services from
the I/O categories as shown in Table 41. These categories accounted for
about 26 percent of All other operating expenses. Finally, we divided
the estimated Administrative Support and Waste Services expenses by the
Total SAS Expenses and the resulting proposed 2017-based MEI cost
weight for Administrative Support and Waste Services is 2.341 percent.
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(e) All Other Services
The proposed weight for All Other Services for the proposed 2017-
based MEI was determined in two steps. First, as was done for other
products, we identified I/O categories (as shown in Table 42)
associated with other services that would crosswalk to the 2017 SAS
data for all other operating expenses. Next, we carved out a portion of
these all other services expenses that were not assigned to
Administrative Support and Waste Services from the I/O categories, the
categories assigned to all other services are shown in Table 35. Using
this information, we determined that All Other Services accounted for
52 percent of the SAS expenses for other operating expenses, or a
weight of 4.762 percent.
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Second, we also proposed to include the expenses directly reported
on the SAS survey for purchased repairs and maintenance to machinery
and equipment in the other services category. The SAS survey
questionnaire defines these expenses to include expensed repair and
maintenance services to machinery, vehicles, equipment, and computer
hardware. These expenses accounted for 0.461 percent of total expenses,
and when added to the 4.762 percent calculated above, results in a
proposed 2017-based MEI cost weight for All Other Services of 5.223
percent.
(f) Professional, Scientific, and Technical Services
The Professional, Scientific and Technical Services cost weight
includes the sum of the 2017 SAS expenses for three categories: (1)
data processing and other purchased computer services, (2) purchased
advertising and promotional services, and (3) purchased professional
and technical services. The SAS survey questionnaire defines data
processing and other purchased computer services to include expenses
for web hosting, computer facilities management services, computer
input preparation, data storage, computer time rental, optical scanning
services, and other computer-related advice and services (including
training). The SAS survey questionnaire defines purchased advertising
and promotional services to include marketing and public relations
services. The SAS survey questionnaire defines purchased professional
and technical services to include management consulting, accounting,
auditing, bookkeeping, legal, actuarial, payroll processing,
architectural, engineering, and other professional services. The cost
weight for Professional, Scientific, and Technical Services is 6.350
percent in the proposed 2017-based MEI.
(g) Fixed Capital
The Fixed Capital cost weight includes the sum of the 2017 SAS
expenses for four categories: (1) purchased repairs and maintenance to
buildings, structures, and offices, (2) lease and rental payments for
land, buildings, structures, store spaces, and offices, (3) an
estimated portion of depreciation and amortization charges, and (4)
governmental taxes and license fees. The SAS survey questionnaire
defines purchased repairs and maintenance to buildings, structures, and
offices as repair and maintenance to integral parts of buildings (for
example, elevators, heating systems). The SAS survey questionnaire
defines lease and rental payments for land, buildings, structures,
store spaces, and offices to include the rental or lease expenses paid
for these items including any penalties incurred for broken leases. The
SAS survey questionnaire defines depreciation and amortization charges
to include depreciation charges taken against tangible assets owned and
used by this firm, tangible assets owned and used by this firm within
leaseholds, tangible assets obtained through capital lease agreements,
and amortization charges against intangible assets (patents,
copyrights). We proposed to include the share of the depreciation
expenses applicable to only the
[[Page 69698]]
structures by multiplying the total depreciation expenses by the share
of total lease and rental payments that were associated with land,
buildings, structures, store spaces, and offices as reported on the
SAS, which is 89 percent. The SAS survey question defines governmental
taxes and license fees as payments to government agencies for taxes and
licenses including business and property taxes. The proposed cost
weight for Fixed Capital for the proposed 2017-based MEI is 5.527
percent.
(h) Moveable Capital
The Moveable Capital cost weight includes the sum of the 2017 SAS
expenses for five categories: (1) expensed equipment, (2) expensed
purchases of other materials, parts, and supplies, (3) expensed
purchases of software, (4) an estimated portion of depreciation and
amortization charges, and (5) lease and rental payments for machinery,
equipment, and other tangible items. The SAS survey questionnaire
defines expensed equipment as expensed computer hardware and other
equipment (for example, copiers, fax machines, phones, shop and lab
equipment, CPUs, monitors). The SAS survey questionnaire defines
depreciation and amortization charges to include depreciation charges
taken against tangible assets owned and used by this firm, tangible
assets owned and used by this firm within leaseholds, tangible assets
obtained through capital lease agreements, and amortization charges
against intangible assets (patents, copyrights). We proposed to include
the share of the depreciation expenses applicable to only the machinery
and equipment by multiplying the total depreciation expenses by the
share of total lease and rental payments associated with machinery and
equipment as reported on the SAS, which is 11 percent. The SAS survey
question defines lease and rental payments for machinery, equipment,
and other tangible items as lease and rental of transportation
equipment without operators including penalties incurred for broken
lease agreements. The proposed cost weight for Moveable Capital for the
proposed 2017-based MEI is 2.221 percent.
(i) Professional Liability Insurance (PLI)
The Professional Liability Insurance (PLI) cost weight includes
2017 SAS expenses reported for professional liability insurance. The
SAS survey questionnaire defines professional liability insurance as
the premiums paid for professional liability insurance and the amounts
set aside for self-insurance. The proposed cost weight for PLI is 1.398
percent in the proposed 2017-based MEI.
(j) Medical Supplies
The Medical Supplies cost weight includes 2017 SAS expenses
reported for Medical supplies with an adjustment to remove the
estimated expenses for drugs and separately billable medical supplies.
The SAS survey questionnaire defines medical supplies as the materials
and supplies used to provide medical services to others (except for
medical equipment). Since the reported expenses in the SAS would
include the expenses for drugs and biologicals, as well as the expenses
for supplies that generally are paid separately under Medicare we
proposed to remove the expenses for these two items from the SAS
expenses reported using the following methodology:
Step 1: To remove the separately billable drug expenses, we rely on
the reported expenses for separately billable drugs from the 2006 AMA
PPIS data. We inflate the reported AMA PPIS expenses for separately
billable drugs to 2017 using the growth in Medicare Part B physician-
administered drug spending. Using this method, we inflated the 2006 AMA
PPIS expenses for separately billable drugs to 2017 by an increase
factor of 1.784 (or 78.4 percent).
Step 2: To remove the non-separately billable drug expenses, we
rely on a similar method where we start with the reported expenses for
non-separately billable drugs from the 2006 AMA PPIS data. We inflate
the reported AMA PPIS expenses for non-separately billable drugs to
2017 using the growth in the PPI for prescription drugs. Using this
method, we inflate the 2006 AMA PPIS expenses for non-separately
billable drugs to 2017 by an increase factor of 2.122 (or 112.2
percent).
Step 3: To remove the non-separately billable supply expenses, we
start with the reported expenses for non-separately billable supplies
from the 2006 AMA PPIS data. We inflate the reported AMA PPIS expenses
for non-separately billable supplies to 2017 using the growth in the
Medical supplies price proxy in the 2006-based MEI (a 50/50 blend of
the PPI--Commodity--Medical and surgical appliances and supplies and
the CPI--Medical equipment and supplies). Using this method, we inflate
the 2006 AMA PPIS expenses for non-separately billable supplies to 2017
by an increase factor of 1.048 (or 4.8 percent).
Step 4: We then calculate the share of estimated 2017 expenses for
all drugs and separately billable supplies from steps 1-3 as a
percentage of total drugs and medical supplies expenses from the 2017
SAS for NAICS 6211. This share is 80 percent.
Step 5: We multiply the SAS 2017 total medical supplies expenses by
a factor of 0.2 (or 1-0.8) in order to estimate the 2017 SAS expenses
for non-separately billable medical supplies only.
Taking the 2017 estimated expenses for non-separately billable
medical supplies as a ratio of total expenses as reported on the 2017
SAS for NAICS 6211 results in a proposed Medical Supplies cost weight
of 2.071 percent in the proposed 2017-based MEI.
The following is a summary of the public comments received on the
proposed 2017-based MEI and our responses:
Comment: Many commenters agreed that the data currently used for
the MEI is outdated and endorsed the principle of having a methodology
that allows for regular and frequent updates to the MEI in the future
to help ensure that payment rates reflect the current underlying
realities of work, practice expenses, and malpractice insurance. A few
commenters supported the proposal to update the MEI using publicly
available data sources to estimate base year expenses that reflect
current market conditions, thus they supported moving forward using the
proposed 2017-based MEI methodology. However, a majority of the
commenters urged CMS to delay any change in the MEI until the AMA's
practice cost data collection work is completed in order to compare the
weights based on the AMA and SAS data. The commenters noted that this
will allow interested parties a better ability to provide comments on
the potential impact to the PFS of refinements to physician practice
expense distributions. Some commenters stated they believe it is
important to retain consistency with the MEI measurement that has been
based on data collected from the AMA Physician Practice Information
(PPI) Survey that has been used by CMS since 1975. Some commenters
stated that if the MEI revisions are adopted, they urge that they be
phased in over a period of at least four years. Commenters noted that a
transition approach would be consistent with other significant payment
changes in the PFS including how CMS updated prices of supply and
equipment inputs and its current transition of clinical labor updates
for use in its PE methodology.
Response: As detailed in the proposed rule (87 FR 46419 through
46425), we are continuing to use the current 2006-
[[Page 69699]]
based MEI cost share weights for CY 2023 PFS ratesetting and GPCIs,
effectively delaying the implementation of the rebased and revised MEI
cost share weights for purposes of PFS ratesetting and CY 2023 GPCIs.
However, we believe that it is important to rebase and revise the MEI
to a more recent period. We look forward to reviewing future data when
that information is available to compare to the results to our proposed
methodology.
Comment: MedPAC commented that they support CMS' proposal to rebase
the MEI using data from 2017 because the MEI is currently based on data
on physicians' expenses from 2006, which raises questions about its
accuracy. However, they stated that CMS' proposed methodology for
rebasing the MEI is not transparent and relies on several disparate
data sources because no single data source contains information at the
level of detail necessary to rebase the MEI. The commenter also stated
that in the long term, CMS should strive to identify or develop a
single data source that has more comprehensive information about
physicians' input costs, such as physician compensation and
compensation for other workers. However, the commenter supported CMS
using its proposed rebased MEI in the interim, as well as waiting until
2024 to use the new MEI cost weights to update the practice expense
GPCI cost share weights and to recalibrate the total pools of physician
work, PE, and PLI RVUs.
Response: We agree that the current 2006-based MEI is outdated and
this raises questions about its accuracy for measuring input price
inflation for providing physician services. We provided detailed
explanations of which data sources were used and while we agree that
the methodology is complex as it relies on several disparate data
sources, we believe that we have proposed a methodology that relies on
the best available data for this purpose. For this final rule we have
included additional language in order to more clearly explain how we
have combined data sources to disaggregate cost data. We also would
highlight that we believe that the proposed methodology for the 2017-
based MEI relies on data that are updated on a regular basis, publicly
available, and reflective of the changing practice patterns of the
overall industry.
We appreciate the commenter's suggestion that CMS identify or
develop a single data source that has more comprehensive information
about physicians' input costs. While we share these aspirations, we are
not currently aware of any such data source. We will continue to
explore our options for a more comprehensive data source in the future,
and any changes to the MEI thereof would be proposed in future
rulemaking and subject to public comments.
Comment: One commenter stated concern that the proposed MEI
methodology would include expenses for all types of physician practice
ownership, not just self-employed physicians. They state that they
believe that using all types of physician practice ownership is another
adjustment for which specialized care will shoulder the burden.
Response: We believe that the MEI should reflect the current market
for physician practices. There have been significant changes to
physician practice ownership patterns since the MEI was originally
implemented in the 1970s, and even more recently since the MEI was last
rebased to reflect 2006 experience. Therefore, we believe that it is
technically appropriate for the MEI to reflect the current physician
practice ownership shares rather than only reflecting expenses for
self-employed physicians. We note that the share of self-employed
physicians has declined steadily over time, based on data from the AMA
Physician Practice Benchmark Survey.
Comment: Many commenters stated that the 2017 Service Annual Survey
(SAS) data for the ``Offices of Physicians'' industry was not designed
with the purpose of updating the MEI and that seven percent of the
revenue for ``Offices of Physicians'' on the 2017 SAS was from non-
patient care sources (for example, grants, investment income) and any
expenses associated with these sources cannot be excluded.
Response: While we agree that there are non-patient care sources of
revenue mixed in with the SAS revenue data, we note that the SAS
revenue data for ``Offices of Physicians'' is used only to estimate the
cost weight for owners of physician practices (or net income). Since
the MEI is comprised of relative costs, the composition of the SAS
revenue data would have a minimal impact on the proposed 2017-based MEI
cost weights. We believe this methodology for estimating the proposed
MEI cost share weights using the 2017 SAS data is a technical
improvement over the 2006-based MEI.
Comment: Many commenters expressed concerns with the proposed
method for splitting the aggregate payroll and benefits expenses from
the SAS data between physician and non-physician compensation. The
commenters stated that the proposed method relies on a series of
assumptions to determine the relative distribution of salaries between
physician and non-physician compensation and results in skewed weights
that underrepresent the portion of physician compensation relative to
non-physician compensation. Commenters had several specific concerns
with the proposed method.
First, commenters stated that both the Census Bureau's SAS and BLS
OEWS datasets only include costs for employed physicians within NAICS
6211 and excludes 36 percent of physicians who are employed in other
health care settings, such as hospitals. The commenters claim that
hospital-based physicians have a higher proportion of physician
earnings and PLI cost relative to other practice costs, as many of
these other costs are the responsibility of the hospital or other
facility.
Secondly, commenters stated that the proposed methodology for
estimating compensation for practice owners (that is, net income) to be
unreasonable. The commenters stated that the estimated share of net
income represents just 10 percent of total compensation for all
physicians and QHPs, which they claim is an unreasonable estimate since
nearly half of physicians in the United States are owners.
The third methodological concern raised was the estimated share of
employee compensation attributed to physicians and QHPs from the 2017
of 63.2 percent is incorrect because it incorrectly classified
registered nurses (RNs) in the estimated share of physician expenses
rather than classified to non-physician compensation.
Finally, MedPAC suggested that the occupational splits derived from
the OEWS data as proposed do not account for differences in the number
of hours worked by different occupational categories. The commenter
suggested that including differentials in the average hours worked by
occupation is technically appropriate and should be considered.
Response: As mentioned by commenters, the SAS expense data does not
explicitly report compensation separately for physicians/QHPs and non-
physicians, and therefore, we proposed a methodology relying on other
data sources in order to split the costs between the two categories of
workers. Though we agree with the first comment that both the SAS and
OEWS for NAICS 6211, Offices of Physicians, do not include expenses or
revenues for physicians who are employed in other healthcare settings
directly, such as hospitals, we do not believe that
[[Page 69700]]
including costs for physicians that do not incur any operating expenses
associated with running a practice would be technically appropriate. We
note that the establishments selected for NAICS 6211, Offices of
Physicians are defined as establishments of health practitioners having
the degree of M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathy)
primarily engaged in the independent practice of general or specialized
medicine (for example, anesthesiology, oncology, ophthalmology,
psychiatry) or surgery. These practitioners operate private or group
practices in their own offices (for example, centers or clinics) or in
the facilities of others, such as hospitals or HMO medical centers.
Therefore, while the SAS data would not necessarily reflect physicians
directly employed by a hospital they would reflect establishments that
operate physician offices in other settings such as hospitals or HMO
medical centers. Additionally, the current cost share weights based on
the 2006 AMA Physician Practice Information Survey (PPIS) data also
appropriately do not reflect the expenses of physicians employed
directly by other industries such as hospitals or skilled nursing
facilities. Therefore, we believe that the SAS and BLS OEWS data for
Offices of Physicians are technically appropriate data sources to use
to derive the cost share weights for the index that measures relative
input price pressures of providing physician services.
In response to commenters' second concern, the proposed methodology
for estimating the net income for practice owners from the 2017 SAS
data was developed to capture the proportion of net income from a
physician practice that would reflect physician compensation but is not
reported as payroll. The 2017 SAS data includes gross payroll expenses
for employees, which would exclude the proportion of expenses that are
compensation to proprietors or partners for unincorporated businesses.
A sole proprietorship or partnership is often an unincorporated
business owned and run by one or more individuals, with no distinction
between the business and its owner. The owners of these unincorporated
businesses are entitled to all profits and are also solely responsible
for all the business's debts, losses and liabilities. Based on this
definition, income to sole proprietors and partnerships from profits is
not captured in the SAS gross payroll data; however, employed
physicians who are not sole proprietors or unincorporated business
would be eligible for inclusion in the sample and their compensation
would be reported in the gross payroll costs. Therefore, we proposed to
include a proportion of net income for owners of physician offices that
are sole proprietors, partnerships, or unincorporated businesses to
physician compensation expenses estimated from the SAS.
As discussed in the proposed rule, in order to adjust the 2017 SAS
expense levels, we first calculated the total net income for the
industry. Within the SAS survey data for Offices of Physicians, the
difference between total revenues and expenses would reflect
compensation to the physician (net income) as well as funds that are
likely reinvested in the business or used for other purposes, such as
expansion or savings. Therefore, we proposed to allocate only a portion
of the 2017 difference between revenues and expenses to physician
compensation to account for the net income of owners of unincorporated
businesses, and we believed using the proportion of physicians that are
self-employed to be a reasonable assumption in determining this
adjustment. We note that the estimated share of net income from the SAS
data declined from 11.3 percent in 2006 to 9.2 percent in 2017. At the
same time the percentage of physicians reported as owners of a practice
rather than employees declined from 61 percent in 2006 to 46.5 percent
in 2017, according to the AMA Physician Practice Benchmark Survey data.
Given that the commenters felt that the proposed method to estimate
net income wasn't reflecting the proportion of the revenue and expense
difference that was allocated to physician compensation, we conducted
further research and considered an alternative method. The IRS
Statistics of Income (SOI) data for Offices of Physicians, by type of
ownership, provides the level of revenue/receipts and net income
separately for corporations, partnerships, and sole proprietors. The
2017 SOI data shows that net income as a share of total receipts varies
across ownership type. For example, the share of net income as a
percentage of revenue is 49.6 percent for sole proprietors, 19.5
percent for partnerships, and 6.9 percent for corporations. Since the
SAS gross revenue less expenses amount would reflect a combination of
ownership types, we believe that revising our method to account for the
differences in shares of net income, by ownership type, would be an
improvement over using the share of self-employed physicians of overall
physicians. Our revised method is based on the following steps:
Step 1: We estimated the share of total revenue for the three
ownership types as reported on the 2017 IRS SOI data. For NAICS 6211,
Offices of Physicians, corporations account for 74 percent of total
industry revenue, partnerships account for 17 percent of total industry
revenue, and sole proprietors account for 8 percent of total industry
revenue. We applied these percentages to the total revenue amount
reported in the 2017 SAS data to estimate the level of revenue for the
three ownership types.
Step 2: Using the 2017 IRS SOI data, we calculated the share of net
income as a percentage of revenue/receipts for the three ownership
types. The share of net income as a percent of revenue for corporations
is 6.9 percent, for partnerships is 19.5 percent, and for sole
proprietors in 49.6 percent.
Step 3: We multiply the share of net income as a percentage of
revenue for corporations, partnerships, and sole proprietors
(calculated in step 2) to the revenue amounts for corporations,
partnerships, and sole proprietors (calculated in step 1) to determine
the net income by ownership type for each of the three practice types.
Step 4: We add the estimated net income for partnerships and sole
proprietors (calculated in step 3) together to determine the amount of
net income from the 2017 SAS data that should be allocated to physician
compensation.
We believe this methodology addresses the commenters' concerns that
the proposed method did not consider the variation in the percentage of
costs assumed to be allocated to net income for sole proprietors and
partnerships. We do not allocate any of the net income or profit for
corporations to physician compensation as we believe that corporations
would use the annual profit to reinvest in the business or for other
business purposes. This revised method for estimating the net income
for physician compensation relies upon IRS data for sole proprietors
and partnerships in order to estimate net income that is not directly
captured by the SAS survey question. We are unaware of any other
publicly available data source available that would provide this
information.
This revised methodology results in an increase in the cost weight
for net income from the proposed 4.8 percent of total expenses to 8.2
percent of total expenses. Additionally, the revised method increases
the share of physician net income as a share of total physician
compensation from 10.3 percent to 16.7 percent of physician
compensation costs. We believe this is a better estimate for deriving
net income since it
[[Page 69701]]
takes into account the differences in the relative share of net income
by ownership type, which the proposed method did not consider.
Therefore, we are finalizing the revised method for estimating the net
income add-on expense amount based on the revised method described
above for the final 2017-based MEI.
In response to commenters' third concern regarding the error in
classification of RN compensation expenses, we agree that registered
nurses (RNs) were inadvertently classified in the estimated share of
physician expenses but would be more appropriately classified in non-
physician compensation. Within the BLS OEWS data, RNs are reported in
the SOC 29-1141. Based on commenters' concerns we reallocated the
associated expenses for RN compensation from Physician Compensation
expenses to Clinical, non-physician Compensation expenses. The revised
distribution results in a smaller share of SAS reported compensation
costs allocated to physician compensation and an increase to the share
of Clinical, non-physician compensation.
In response to the final comment related to including variation in
hours worked by occupation into the methodology for deriving the
physician and non-physician split, we agree with the suggestion that
the estimated shares for Office of Physicians occupational mix could be
refined to account for differences in the number of hours worked by
occupation. We obtained average weekly hours worked by occupation for
NAICS 6211 from the Census Bureau's Current Population Survey (CPS). We
have revised the proposed methodology for estimating the occupational
mix of total compensation shares by multiplying the mean hourly
earnings by occupation from the BLS OEWS survey by the average weekly
hours by occupation from the CPS data. This product of mean hourly wage
* average weekly hours by occupation is then multiplied by the number
of employees by occupation as reported by the BLS OEWS data. This
revised method for estimating the occupational mix shares to account
for variation in the number of hours worked by occupation relies upon
data captured by the CPS. We are unaware of any other publicly
available data source that would provide this information.
The revised distribution of the compensation weights accounting for
both a reclassification of RNs to clinical non-physician compensation
and accounting for average hours worked, by occupation, is shown in
Table 43. Accounting for the differences in the average weekly hours by
occupation increases the weight for physician compensation and
decreases the weight for clinical, non-physician compensation, and non-
health related compensation compared to the proposed 2017-based MEI.
[GRAPHIC] [TIFF OMITTED] TR18NO22.710
For the reasons detailed above, we believe that the three
methodological revisions to the proposed method based on public comment
feedback produces an improvement to the decomposition of SAS
compensation expenses between physician compensation and non-physician
compensation for purposes of the MEI.
Comment: Several commenters noted they did not agree with the
proposed method to exclude expenses for separately billable supplies
and drugs. Commenters stated that the use of growth in Medicare Part B
drug spending to age expenses forward is not entirely appropriate and
that the use of an index that is inclusive of all drugs, such as the
CPI or PPI to account for inflation would be better. Commenters also
expressed concern that the total expenses that were being compared were
estimated from different surveys and the expenses to include in each
survey could be entirely different.
Response: We disagree with commenters' concerns with the proposed
approach for estimating the portion of separately billable supply and
drug expenses. We believe that the question on the AMA PPIS survey for
drugs and medical supplies align similarly with the types of expenses
collected on the SAS survey questionnaire. The SAS survey questions for
medical supply expenses asks respondents to report the costs for
materials and supplies used in providing medical services to others
(and States not to include costs for medical equipment in this amount).
This medical supply expense would include drug costs as well as other
medical supply costs. The AMA PPIS survey collects the expenses for
drugs and medical supplies using two separate questions. The AMA
question for medical supply expenses asks respondents to report ``total
expenses for medical supplies such as sterile gloves, needles,
bandages, specimen containers, and catheters.'' The AMA question also
instructs respondents to not include expenses for medical equipment
costs with medical supplies. The question for drug expenses asks
respondents to report ``total expenses for all drugs administered in
the office (for example, local anesthetics, infusions, antibiotics,
vaccines) and instructs respondents to report the cost of the drugs,
after considering any discounts and rebates.'' Additionally, the two
questions on the AMA PPIS survey for medical supplies and drugs asks
for the dollar amount of medical supplies and drugs that were
separately billable; this information is not collected on the SAS
questionnaire. Given the data available, we believe that the proposed
method for removing all
[[Page 69702]]
drug expenses and separately billable supply expenses for the 2017-
based MEI is appropriate and is consistent with how these costs were
excluded in the 2006-based MEI. The estimated price growth in Part B
drugs and the estimated growth in the PPI for prescription drugs are
relatively similar. The proposed method excludes approximately 80
percent of medical supply expenses from the SAS data. If the separately
billable drug expenses were inflated by the PPI for prescription drugs
instead of the growth in Part B drug spending, then 81.8 percent of
expenses would be excluded rather than 80 percent. We believe that the
difference between the two methods is insignificant and believe the
proposed approach is the better one.
Comment: Many commenters stated that the decrease in the weight for
PLI costs was unrealistic. One commenter noted that a weight of 1.4
percent applied to Medicare spending on its share of these premiums and
self-insured actuarial costs would equate to an unreasonably low
premium amount that would contradict CMS's volume weighted national PLI
premium costs of $21,700. The commenters, using this logic, stated that
they believe a 4-5 percent PLI weight is more appropriate than the
proposed 1.4 percent weight.
Response: The proposed cost share weight for the 2017-based MEI,
reflecting all types of physician ownership practices is substantially
lower than the current 2006-based MEI PLI weight, which reflected the
relative cost of PLI for self-employed physicians only. The drop in the
PLI weight is the result of using both a more recent year of physician
cost data as well as also using a sample of physicians that is
inclusive of various ownership types.
Based on analysis of several data sources, the 2017 cost weight for
PLI shows that it is lower than the weight in the 2006-based MEI. For
example, the IRS Statistics of Income data for Sole Proprietors shows a
2006 PLI cost share weight of about 3.9 percent, which is relatively
close to the 2006-based MEI PLI weight of 4.3 percent based on AMA PPIS
data. Using the same data source the SOI data shows a 2017 PLI weight
of 2.1 percent. This information indicates that trends between 2006 and
2017 for self-employed, sole proprietors would by itself result in a
drop of approximately 2 percentage points.
However, as mentioned earlier, the data for the proposed 2017-based
MEI also includes corporations and physician group practices that are
not self-employed, including those that are hospital owned. These
practices tend to be larger and have higher overall expenses than sole
proprietor physician offices; additionally, group practice data
indicates the relative share of PLI expenses is even lower (for
instance, one private data source indicates a PLI weight below 1
percent in recent years).
For these reasons, we believe the proposed 2017-based cost weight
is appropriate, given the data sources available reporting these costs.
As we noted, the PLI weight in the MEI reflects the total expenses
associated with paid PLI premiums for the industry relative to the
total costs for other business expenses such as compensation, and
equipment costs. Thus, it is not comparable to a measure of an average
national premium such as the CMS national PLI premium cost of $21,700
referenced in the rule.
After consideration of the public comments, we are finalizing the
proposed 2017-based MEI cost share weights as proposed for all cost
categories in the MEI except for the compensation cost category weights
where we are revising the methodology based on public comments received
and summarized above. Specifically, we are: (1) revising the
methodology for estimating the 2017 expenses for physician net income;
(2) correcting the allocation of registered nurse (RN) compensation
costs from physician compensation to clinical, non-physician
compensation; and (3) adjusting the shares for allocating SAS
compensation costs between physician and non-physicians by factoring in
differences in average weekly hours by occupation. The following
section highlights the specific changes we are finalizing to the
proposed methodology and the resulting revised 2017-based MEI weights
relative to both the 2006-based and the proposed 2017-based MEI
weights.
The development of the revised cost weights based on public
comments is described, in detail, as follows.
a. Physician's Compensation
The component of the MEI that reflects physician work is
represented by the estimated portion of compensation expenses
attributable to physicians. The revised 2017 cost weight associated
with the physician's work (otherwise referred to as the Physician
Compensation cost weight) is based on the estimated share of 2017 SAS
expenses for total compensation associated with physician compensation.
Since the compensation expense in the SAS data is only reported as an
aggregate for all employees, we split the compensation expenses between
physicians (including non-physician practitioners that can bill
independently such as nurse practitioners (NPs), physician assistants
(PAs), and other clinical personnel) and all other workers using the
following process.
Step 1: Total compensation costs are calculated by summing the
reported expenses in the SAS for gross annual payroll, employer costs
for fringe benefits (including health insurance, defined benefit and
defined contribution plans, payroll taxes, employer paid insurance
premiums, and all other benefits), and temporary staff and leased
employees as reported in the 2017 SAS data for NAICS 6211 (Office of
Physicians).
Step 2: Determine the ratio of physician (including non-physician
practitioners that can bill independently such as NPs, PAs, and other
clinical personnel) wage costs to total wage costs. This ratio is
calculated using data from the Bureau of Labor Statistics (BLS)
Occupational Employment and Wage Statistics (OEWS) May 2017 National
Industry-Specific Occupational Employment and Wage Estimates for
Offices of Physicians (NAICS 6211). This data reports the number of
employees by occupational category based on the Standard Occupational
Classification System (SOC) and the mean hourly wage for each
occupation. We proposed to revise the calculation of expenses for each
occupation to also account for the variation in the average weekly
hours worked, which were obtained for NAICS 6211 from the Census
Bureau's Current Population Survey (CPS). Therefore, for each
occupation, we multiply the number of employees by the mean hourly wage
times the average weekly hours to estimate the total mean weekly wage
expense. The sum of weekly expenses for each occupation category
represents total mean weekly wage expenses for all occupations in NAICS
6211. Then to derive the total mean weekly wage expenses for physicians
(including non-physician practitioners that can bill independently such
as NPs, PAs, and other clinical personnel) we sum the expenses for the
following occupations: Physicians and Surgeons (29-1060); Chiropractor
(29-1011); Optometrist (29-1041); Podiatrist (29-1081); Physical
Therapist (29-1123); Dieticians & Nutritionists (29-1031); Physician
Assistants (29-1071); Nurse Practitioners (29-1171); and All Other
Diagnosing & Treating Occupations (29-11XX). We note that the proposed
methodology included the allocation of compensation costs for
Registered Nurses (29-1141) within the All Other Diagnosing & Treating
Occupations category (29-11XX). As commenters highlighted, the
compensation expenses
[[Page 69703]]
for RNs were inadvertently allocated to physician compensation.
Therefore, we are correcting this error and correctly allocating these
costs to the clinical, non-physician compensation cost category. As a
result of these revisions, the ratio of physician mean weekly wage
costs to total mean weekly wage costs falls to 60.7 percent compared to
the proposed 63.2 percent. This change is the combination of two
offsetting effects, correcting for the classification of RN expenses to
clinical, non-physician compensation lowers the physician compensation
share from 63.2 percent to 55.7 percent; then accounting for
differences in weekly hours by occupation subsequently increases the
physician compensation share from 55.7 percent to 60.7 percent.
Step 3: We multiply the total compensation expenses from Step 1 by
the revised ratio of 60.7 percent determined in Step 2 to derive the
revised Employed Physician Compensation Expenses, or 39.3 percent of
total costs.
Next, since the expenses estimated above reflect only employed
physician compensation, we proposed to add an estimate of compensation
costs to account for physician practice owners that are not classified
as employees but instead would be included in the net income of the
practice. Based on comments received we re-evaluated the proposed
methodology used to estimate the net income expenses.
The IRS Statistics of Income (SOI) data for Offices of Physicians,
by type of ownership provides the level of revenue/receipts and net
income separately for corporations, partnerships, and sole proprietors.
The 2017 SOI data shows that net income as a share of total receipts
varies across ownership type. For example, the share of net income as a
percentage of revenue is 49.6 percent for sole proprietors, 19.5
percent for partnerships, and 6.9 percent for corporations. Since the
SAS revenue less expense amount would reflect a combination of
ownership types we revised our method to account for the differences in
shares of net income, by ownership type using the following steps:
Step 1: We estimated the share of total revenue for the three
ownership types as reported on the 2017 IRS SOI data. For NAICS 6211,
Offices of Physicians, corporations account for 74 percent of total
industry revenue, partnerships account for 17 percent of total industry
revenue, and sole proprietors account for 8 percent of total industry
revenue. We applied these percentages to the total revenue amount
reported in the 2017 SAS data to estimate the level of revenue for the
three ownership types.
Step 2: Using the 2017 IRS SOI data, we calculated the share of net
income as a percentage of revenue/receipts for the three ownership
types. The share of net income as a percent of revenue for corporations
is 6.9 percent, for partnerships is 19.5 percent, and for sole
proprietors in 49.6 percent.
Step 3: We multiply the share of net income as a percentage of
revenue for corporations, partnerships, and sole proprietors
(calculated in step 2) to the revenue amounts for corporations,
partnerships, and sole proprietors (calculated in step 1) to determine
the net income by ownership type for each of the three practice types.
Step 4: We add the estimated net income for partnerships and sole
proprietors (calculated in step 3) together to determine the amount of
net income from the 2017 SAS data that should be allocated to physician
compensation. We do not allocate any of the net income or profit for
corporations to physician compensation as we believe that corporations
would use the annual profit to reinvest in the business or for other
business purposes.
This revised methodology results in an increase in the cost weight
for net income from the proposed 4.8 percent of total expenses to 8.2
percent of total expenses. The revised method increases the share of
physician net income as a share of total physician compensation from
10.3 percent to 16.7 percent of physician compensation costs.
The revised aggregate 2017-based Physician Compensation cost weight
is the sum of the Employed Physician Compensation cost weight (39.297
percent) and estimated Net Income for Physician Practice Owners cost
weight (8.226 percent), or 47.522 percent. By comparison, the 2006-
based Physician Compensation cost weight was 50.866 percent. The
revised 2017-based MEI cost weight for Physician Compensation is 0.3
percentage point higher than the proposed 2017-based MEI cost weight
and is 3.3 percentage points lower than the 2006-based MEI cost weight.
We proposed to split the Physician Compensation cost weight into
two cost categories: Physician Wages and Salaries and Physician
Benefits. We did not make any revisions to the proposed methodology for
splitting physician compensation into Physician Wages and Salaries and
Physician Benefits, therefore we split the physician compensation
weight between wages and benefits using an 83/17 split. As a result,
the Physician Wages and Salaries cost weight is 39.443 percent and the
Physician Benefits cost weight is 8.079 percent in the revised 2017-
based MEI.
b. Practice Expenses
The Practice Expenses cost weight reflects all remaining operating
costs other than physician compensation. Based on public comments
received on the proposed method, we are revising the cost weights for
the non-physician compensation categories. We are finalizing the cost
category weights for all practice expense cost categories other than
non-physician compensation cost categories as proposed. We explain the
revisions to the cost weights for the non-physician compensation
practice expense cost weights.
(1) Non-Physician Compensation
We proposed to estimate the cost weight for Non-physician
Compensation using the 2017 SAS data for these expenses. As mentioned
previously, since the compensation expenses in the SAS data are only
reported as an aggregate for all employees, we proposed to multiply the
2017 SAS total compensation expenses for NAICS 6211 by the residual of
the share determined for physicians (including non-physician
practitioners that can bill independently such as NPs, PAs, and other
clinical personnel). The revised share for non-physician compensation
is 39.307 percent. Multiplying the total compensation expenses by this
ratio results in the final Non-physician Compensation cost weight of
25.451 percent, slightly higher than the proposed 24.716 percent.
Finally, we revised the weights for disaggregating the non-
physician wages and salaries into two categories: (1) Health-related,
non-physician and (2) Non-health, non-physician Wages and Salaries.
Of the 39.3 percent of total SAS compensation costs associated with
non-physicians, 19.1 percentage points are determined to be associated
with Health-related, non-physician Wages and Salaries. This percentage
reflects the ratio of mean weekly wages to total mean weekly wages from
the 2017 OEWS data for the following occupations: Registered Nurses
(RNs) (29-1141); Health Technologists and Technicians (29-2000); Other
Healthcare Practitioners and Technical (29-9000); and Healthcare
Support (31-0000). Applying this share (about 49 percent) to the non-
physician wages cost weight results in a weight of 10.858 percent for
the health-related, non-physician Wages and Salaries cost weight for
the final 2017-based MEI.
The remaining share of non-physician compensation costs are
associated with
[[Page 69704]]
non-health, non-physician Wages and Salaries (20.2 percentage points of
the 39.3 percent). This percentage reflects the ratio of mean weekly
wages to total mean weekly wages from the 2017 OEWS data for the
following occupations: Management (11-0000); Business and Financial
Operations (13-0000); Computer and Mathematical (15-0000); Architecture
and Engineering (17-0000); Life, Physical, and Social Science (19-
0000); Community and Social Service (21-0000); Legal (23-0000);
Education, Training, and Library (25-0000); Arts, Design,
Entertainment, Sports, and Media (27-0000); Protective Service (33-
0000); Food Preparation and Serving Related (35-0000); Building and
Grounds Cleaning and Maintenance (37-0000); Personal Care and Service
(39-0000); Sales and Related (41-0000); Office and Administrative
Support (43-0000); Construction and Extraction (47-0000); Installation,
Maintenance, and Repair (49-0000); Production (51-0000); and
Transportation and Material Moving (53-0000). Applying this share
(about 51 percent) to the non-physician wages cost weight results in a
weight of 10.266 percent for the non-health, non-physician Wages and
Salaries cost weight for the final 2017-based MEI.
Next, since the non-health, non-physician wages represent various
types of occupations that may experience different wage inflation
pressures, we proposed to disaggregate the non-health, non-physician
Wages and Salaries cost weight into four occupational subcategories. To
arrive at a distribution for these separate occupational categories
(Professional & Related (P&R) workers, Managers, Clerical workers, and
Service workers), we determined an estimate of annual earnings for each
using the Standard Occupational Classification (SOC) system. While we
did not make any changes to the occupations included in each of the
categories from what was proposed, the final cost weights are revised
due to the revised non-physician wages and salary weight and the
inclusion of average weekly hours by occupation.
The non-health, non-physician Wages and Salaries cost weight of
10.858 percent is multiplied by the relative share of each category to
arrive at the detailed distribution. The occupational distribution in
the final 2017-based MEI, the proposed 2017-based MEI, and the 2006-
based MEI is presented in Table 44.
[GRAPHIC] [TIFF OMITTED] TR18NO22.073
Table 45 lists the set of mutually exclusive and exhaustive cost
categories and weights for the final 2017-based MEI, proposed 2017-
based MEI, and the 2006-based MEI. While the methodology for deriving
all other practice expenses did not change from the proposed method,
their cost share weights are slightly lower due to the increases in
total expenses that reflect the revised method for estimating physician
net income; that is, both physician compensation and total expenses
were higher based on the revised method in response to public comments.
BILLING CODE 4150-28-P
[[Page 69705]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.074
BILLING CODE 4150-28-C
3. Selection of Price Proxies for Use in the MEI
To select prices proxies for the proposed 2017-based MEI cost
categories, most of the proxy measures we considered are based on BLS
data and are grouped into one of the following four categories:
Producer Price Indices (PPIs): PPIs measure the average
change over time in the selling prices received by domestic producers
for their output. The prices included in the PPI are from the first
commercial transaction for many products and some services (https://www.bls.gov/ppi/).
Consumer Price Indices (CPIs): CPIs measure the average
change over time in the prices paid by urban consumers for a market
basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs
are only used when the purchases are similar to those of retail
consumers rather than purchases at the producer level, or if no
appropriate PPIs are available or if the particular expenditure
category is likely to contain purchases made at the final point of
sale.
Employment Cost Indices (ECIs): ECIs measure the rate of
change in employee wage rates and employer costs for employee benefits
per hour worked. These indexes are fixed-weight indexes and strictly
measure the change in wage rates and employee benefits per hour. ECIs
are superior to Average Hourly Earnings (AHE) as price proxies for
input price indexes because they are not affected by shifts in
occupation or industry mix, and because they measure pure price change
and are available by both occupational group and by industry. The
industry ECIs are based on the NAICS and the occupational ECIs are
based on the Standard Occupational Classification System (SOC). We
evaluated the price proxies using the criteria of reliability,
timeliness, availability, and relevance:
Reliability: Reliability indicates that the index is based
on valid statistical methods and has low sampling variability. Widely
accepted statistical methods ensure that the data were collected and
aggregated in a way that can be replicated. Low sampling variability is
desirable because it indicates that the sample reflects the typical
members of the population. (Sampling variability is variation that
occurs by chance because only a sample was surveyed rather than the
entire population.)
Timeliness: Timeliness implies that the proxy is published
regularly, preferably at least once a quarter. The MEI levels are
updated quarterly, and therefore, it is important for the underlying
price proxies to be up-to-date, reflecting the most recent data
available. We believe that using proxies that are published regularly
(at least quarterly, whenever possible) helps to ensure that we are
using the most recent
[[Page 69706]]
data available to update the MEI. We strive to use publications that
are disseminated frequently, because we believe that this is an optimal
way to stay abreast of the most current data available.
Availability: Availability means that the proxy is
publicly available. We prefer that our proxies are publicly available
because this will help ensure that the MEI updates are as transparent
to the public as possible. In addition, this enables the public to be
able to obtain the price proxy data on a regular basis.
Relevance means that the proxy is applicable and
representative of the cost category weight to which it is applied.
As discussed in the proposed rule, we believe the proposed PPIs,
CPIs, and ECIs selected meet these criteria. Therefore, we believe that
they continue to be the best measure of price changes for the cost
categories to which they would be applied. In this rule, we present a
detailed explanation of the price proxies that we proposed for each
cost category weight. We noted that many of the proxies that we
proposed to use for the proposed 2017-based MEI (as shown in Table 36)
are the same as those used in the 2006-based MEI except as noted below.
a. Physician Compensation
(1) Physician Wages and Salaries
We proposed to continue to use the ECI for Wages and Salaries for
Professional and Related Occupations (Private Industry) (BLS series
code CIU2020000120000I) to measure price growth of this category in the
proposed 2017-based MEI. We noted that we believe this price proxy
reflects the wage pressures faced by physicians in that it captures
wage trends in labor markets of skilled professional workers without
being directly affected by trends in physician income that may be
influenced by the ownership structure of physician practices. This
price proxy also follows the recommendation of the MEI-TAP that the
price proxy would maintain consistency with the guidance provided in
the 1972 Senate Finance Committee report titled ``Social Security
Amendments of 1972,'' which stated that the index should reflect
changes in practice expenses and ``general earnings''. This is the same
proxy used in the 2006-based MEI.
(2) Physician Benefits
We proposed to continue to use the ECI for Benefits for
Professional and Related Occupations (Private Industry) to measure
price growth of this category in the proposed 2017-based MEI. The ECI
for Benefits for Professional and Related Occupations is derived using
BLS's Total Compensation for Professional and Related Occupations (BLS
series ID CIU2010000120000I) and the relative importance of wages and
salaries within total compensation. We believe this series is
technically appropriate because it better reflects the benefit trends
for professionals requiring advanced training. This is the same proxy
used in the 2006-based MEI.
b. Practice Expense
(1) Non-Health, Non-Physician Wages and Salaries
Professional and Related: We proposed to continue using
the ECI for Wages and Salaries for Professional and Related Occupation
(Private Industry) (BLS series code CIU2020000120000I) to measure the
price growth of this cost category. This is the same proxy used in the
2006-based MEI.
Management: We proposed to continue using the ECI for
Wages and Salaries for Management, Business, and Financial (Private
Industry) (BLS series code CIU2020000110000I) to measure the price
growth of this cost category. This is the same proxy used in the 2006-
based MEI.
Clerical: We proposed to continue using the ECI for Wages
and Salaries for Office and Administrative Support (Private Industry)
(BLS series code CIU2020000220000I) to measure the price growth of this
cost category. This is the same proxy used in the 2006-based MEI.
Services: We proposed to continue using the ECI for Wages
and Salaries for Service Occupations (Private Industry) (BLS series
code CIU2020000300000I) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(2) Non-Physician, Health-Related Wages and Salaries
We proposed to continue to use the ECI for Wages and Salaries for
Hospital Workers (Private Industry) (BLS series code CIU2026220000000I)
to measure the price growth of this cost category in the proposed 2017-
based MEI. The ECI for Hospital workers has an occupational mix that
approximates that of physicians' offices. This is the same proxy used
in the 2006-based MEI.
(3) Non-Physician Benefits
We proposed to continue using a composite ECI for non-physician
employee benefits in the proposed 2017-based MEI. The weights and price
proxies for the composite benefits index are shown in Table 46, which
lists the five ECI series and corresponding weights used to construct
the proposed composite benefit index for non-physician employees in the
proposed 2017-based MEI. We noted the ECI benefits series are derived
based on BLS published data from the applicable Total Compensation ECI
and Wages & Salaries ECI as BLS does not publish the ECI Benefit
Indexes directly.
[GRAPHIC] [TIFF OMITTED] TR18NO22.075
[[Page 69707]]
(4) Other Practice Expense
(a) Utilities
We proposed to continue using the CPI for Fuel and Utilities (BLS
series code CUUR0000SAH2) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(b) All Other Products
We proposed to use the PPI--Final demand--Finished goods less foods
and energy (BLS series code WPUFD413) as the price proxy for this
category. We believe that the expenses for the products that physicians
purchase for use in providing physicians services are better reflected
by purchases at the wholesale or producer level rather than at the
consumer level and the growth in overall prices less food and energy
provides a good approximation for the inflation pressures experienced
for these expenses. The 2006-based MEI used several PPI and CPI series
to proxy the price growth for the products reflected in this category.
(c) Telephone
We proposed to continue using the CPI for Telephone Services (BLS
series code CUUR0000SEED) to measure the price growth of this cost
category in the proposed 2017-based MEI. This is the same proxy used in
the 2006-based MEI.
(d) Professional, Scientific, and Technical Services
We proposed to continue to use the ECI for Total Compensation for
Professional, Scientific, and Technical Services (Private Industry)
(BLS series code CIU2015400000000I) to measure the price growth of this
cost category in the proposed 2017-based MEI. This is the same proxy
used in the 2006-based MEI.
(e) Administrative and Support Services
We proposed to continue to use the ECI for Total Compensation for
Administrative, Support, Waste Management, and Remediation Services
(Private Industry) (BLS series code CIU2015600000000I) to measure the
price growth of this cost category in the 2017-based MEI. This is the
same proxy used in the 2006-based MEI.
(f) All Other Services
We proposed to continue to use the ECI for Compensation for Service
Occupations (Private Industry) (BLS series code CIU2010000300000I) to
measure the price growth of this cost category.
(g) Fixed Capital
We proposed to continue to use the PPI for Lessors of
Nonresidential Buildings (BLS series code PCU531120531120) to measure
the price growth of this cost category in the proposed 2017-based MEI.
This is the same proxy used in the 2006-based MEI.
(h) Moveable Capital
We proposed to continue to use the PPI for Machinery and Equipment
(series code WPU11) to measure the price growth of this cost category
in the proposed 2017-based MEI. This is the same proxy used in the
2006-based MEI.
(i) Professional Liability Insurance
Unlike the other price proxies based on data from BLS and other
public sources, the proxy for PLI is based on data collected directly
by CMS from a sample of commercial insurance carriers. The MEI-TAP
discussed the methodology of the CMS PLI index, as well as considered
alternative data sources for the PLI price proxy, including information
available from BLS and through State insurance commissioners. As
detailed in the CY 2014 PFS final rule (78 FR 74271), the MEI-TAP
``believes the current index appropriately reflects the price changes
in premiums throughout the industry.'' Accordingly, we proposed to
continue using the CMS Physician PLI index to measure the price growth
of this cost category in the proposed 2017-based MEI. This is the same
proxy used in the 2006-based MEI.
(j) Medical Supplies
We proposed to continue using a blended index comprised of 50/50
blend of the PPI for Surgical Appliances (BLS series code WPU156301)
and the CPI-U for Medical Equipment and Supplies (BLS series code
CUUR0000SEMG). This is the same proxy used in the 2006-based MEI.
Table 47 shows the 2017-based MEI cost categories and price
proxies.
[[Page 69708]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.076
We did not receive any comments on the proposed price proxies used
in the MEI and we are finalizing all price proxies as proposed. We note
that the price proxies within the benefits blend are the same as
proposed; however, the final weights for the composite benefits index
have changed due to the revisions we are finalizing to the methodology
for deriving compensation costs (that is, changes to the physician net
income estimated expenses, the correction to classification of RN
compensation expenses, and the inclusion of variation in average hours
worked by occupation). These factors resulted in a change to the
weights for the composite benefits blend relative to the proposed rule
as shown in Table 48.
We are finalizing the continued use of a composite ECI for non-
physician employee benefits in the 2017-based MEI; however, the
relative shares for each of the ECI benefits series within the blend
differ from those presented in the proposed rule because the final
relative shares are updated to reflect the revisions to the methodology
that we are finalizing in this final rule. The weights and price
proxies for the composite benefits index are shown in Table 48, which
lists the five ECI series and corresponding weights used to construct
the final composite benefit index for non-physician employees in the
2017-based MEI. We noted the ECI benefits series are derived based on
BLS published data from the applicable Total Compensation ECI and Wages
& Salaries ECI as BLS does not publish the ECI Benefit Indexes
directly.
[[Page 69709]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.077
4. Productivity Adjustment to the MEI
The MEI has been adjusted for changes in productivity since its
inception. In the CY 2003 PFS final rule with comment period (67 FR
80019), we implemented a change in the way the MEI was adjusted to
account for changes in productivity. The MEI used for the 2003
physician payment update incorporated changes in the 10-year moving
average of private nonfarm business (economy-wide) total factor
productivity (previously referred to as multifactor productivity) that
were applied to the entire index. Previously, the index incorporated
changes in productivity by adjusting the labor portions of the index by
the 10-year moving average of economy-wide private nonfarm business
labor productivity.
The MEI-TAP's Finding 5.1 states that, ``[t]he Panel reviewed the
basis for the current economy-wide multifactor productivity adjustment
(Private Nonfarm Business Multifactor Productivity) in the MEI and
finds such an adjustment continues to be appropriate. This adjustment
prevents ``double counting'' of the effects of productivity
improvements, which would otherwise be reflected in both (i) the
increase in compensation and other input price proxies underlying the
MEI, and (ii) the growth in the number of physician services performed
per unit of input resources, which results from advances in
productivity by individual physician practices.''
We proposed to continue to use the current method of applying a
productivity adjustment to the full MEI increase factor in the proposed
2017-based MEI. As described in the CY 2003 PFS final rule with comment
period, we believe this adjustment is appropriate because it explicitly
reflects the productivity gains associated with all inputs (both labor
and non-labor). We noted that we believe that using the 10-year moving
average percent change in economy-wide total factor productivity is
appropriate for deriving a stable measure that helps alleviate the
influence that the peak (or a trough) of a business cycle may have on
the measure. The adjustment would be based on the latest available
historical economy-wide nonfarm business total factor productivity data
as measured and published by BLS.
We did not receive any comments on the proposed productivity
adjustment to the MEI, and therefore, we are finalizing the
productivity adjustment as proposed.
5. Results of Rebasing and Revising of the MEI
Table 49 illustrates the results of the proposed update to the MEI
cost weights for Physician Compensation, Practice Expenses (excluding
PLI), and PLI from a 2006-based cost distribution, the proposed 2017-
based cost distribution, and the final 2017-based cost distribution
including all the revisions as a result of public comments as
specified.
[GRAPHIC] [TIFF OMITTED] TR18NO22.078
Table 50 shows the average calendar year percent change for CY 2016
to CY 2023 for the 2006-based MEI, the proposed 2017-based MEI, and the
final 2017-based MEI. The final 2017-based MEI annual percent changes
differ from the 2006-based MEI annual percent changes by 0.1 to 0.2
percentage point for any given year.
[[Page 69710]]
[GRAPHIC] [TIFF OMITTED] TR18NO22.079
As shown in Table 50, the percent change of the final 2017-based
MEI, the proposed 2017-based MEI, and the 2006-based MEI for CY 2023 is
an increase of 3.8 percent based on historical data through the 2nd
quarter of 2022.
We did not receive any comments on the proposed updates as a result
of rebasing and revising of the MEI, and, therefore, we are finalizing
the update factor based on the most recent historical estimate of the
MEI increase.
III. Other Provisions of the Final Rule
A. Requiring Manufacturers of Certain Single-Dose Container or Single-
Use Package Drugs To Provide Refunds With Respect to Discarded Amounts
(Sec. Sec. 414.902 and 414.940)
1. Background
Drugs and biologicals payable under Medicare Part B fall into three
general categories: those furnished incident to a physician's service
(hereinafter referred to as ``incident to'') (section 1861(s)(2) of the
Act), those administered via a covered item of durable medical
equipment (DME) (section 1861(s)(6) of the Act), and others as
specified by statute (for example, certain vaccines described in
sections 1861(s)(10)(A) and (B) of the Act). Payment limit amounts for
most drugs and biologicals separately payable under Medicare Part B are
determined using the methodology in section 1847A of the Act, and in
many cases, payment is based on the average sales price (ASP) plus a
statutorily mandated 6 percent add-on. Most drugs payable under Part B
are covered under the ``incident to'' benefit under section 1861(s)(2)
of the Act, which includes drugs and biologicals not usually self-
administered by the patient.
Many drugs and biologicals (hereafter referred to as a drugs)
payable under Medicare Part B are dosed in a variable manner such that
the entire amount identified on the vial or package is not administered
to the patient. For example, many drugs are dosed based on the
patient's body weight or body surface area (BSA). Often times, these
drugs are available only in single-dose containers. As stated in U.S.
Food and Drug Administration (FDA) guidance for industry,\132\ a
single-dose container is designed for use with a single patient as a
single injection or infusion. The FDA-approved labeling for a drug
packaged in a single-dose container typically includes statements
instructing users to discard unused portions. When the labeling
instructs a provider to discard the amount of drug that was unused
(that is, the discarded amount) from a single-dose container or other
single-use package of a drug after administering a dose to a Medicare
beneficiary, the program provides payment for the unused and discarded
amount, as well as the dose administered, up to the amount of the drug
indicated on the vial or package labeling. On a Medicare Part B claim,
the JW modifier (Drug amount discarded/not administered to any patient)
is a Healthcare Common Procedure Coding System (HCPCS) Level II
modifier used to report the amount of a drug that is discarded and
eligible for payment.
---------------------------------------------------------------------------
\132\ https://www.fda.gov/media/117883/download.
---------------------------------------------------------------------------
Beginning on January 1, 2017, CMS revised the JW modifier policy to
require the uniform use of the modifier for all claims for separately
payable drugs with discarded drug amounts from single use vials or
single use packages payable under Part B in order to more effectively
identify and monitor billing and payment for discarded amounts of
drugs.133 134 The policy does not apply to drugs that are
not separately payable, such as packaged hospital outpatient
prospective payment system (OPPS) drugs or those administered in the
Federally qualified health centers (FQHC) or rural health clinics (RHC)
setting. Additional details about this policy can be found in Chapter
17 of the Medicare Claims Processing Manual \135\ and in the JW
modifier frequently asked questions (FAQ) document.\136\
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\133\ CR6603: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3538CP.pdf.
\134\ MLN Matters[supreg] Number MM9603: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf.
\135\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf.
\136\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf.
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Medicare Part B data for discarded amounts of drug (based on the JW
modifier) have been published on the CMS website annually for calendar
years beginning in 2017.\137\ Data for 2020 shows that Medicare paid
nearly $720 million for discarded amounts of drugs from a single-dose
container or single-use package (hereafter referred to as single-dose
container \138\) paid under Part B with claims identifying the
discarded amounts with the JW modifier. JW modifier data from 2020 is
the most recent available at the time of this analysis. This data is
comparable to 2017-2019 with regard to percentage of discarded amounts
and total Medicare spending for discarded drugs each year, which ranged
from approximately $700-750 million each year during that
[[Page 69711]]
time. More than half of Medicare spending for discarded amounts in 2020
represents about 40 billing and payment codes (that is, HCPCS codes),
for which 10 percent or more of the total charges for the drug were for
discarded units. A large proportion of single source drugs with 10
percent or more discarded units are dosed based on patient's body
weight or BSA. We note that the JW modifier data published on the CMS
website is limited to only billing and payment codes that are published
on the ASP Drug Pricing File.\139\ There are likely additional billing
and payment codes payable under Medicare Part B available in single-
dose containers that would be subject to the JW modifier policy and are
not reflected in the data discussed above.
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\137\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
\138\ https://www.fda.gov/media/117883/download.
\139\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice.
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The calculated dose (based on weight or BSA) is drawn from one or
more vials and any remaining amount of the drug is discarded. For
example, if labeled dose of a drug is 20 mg/m\2\, the dose for a
patient with a BSA of 1.9 m\2\ (the approximate average BSA of an adult
male) would be 38 mg. If the drug is available in single-dose 60-mg
vials, then 38 mg would be administered to the patient and 22 mg (36.67
percent) would be discarded. If the ASP payment limit amount
(typically, ASP plus 6 percent) for this drug for a given quarter is
$190 per 1 mg, the total payment for the amount of drug that was
administered to the beneficiary would be $7,220 and for the amount of
drug that was discarded would be $4,180. Both the amount of drug
administered and the amount discarded (consistent with the discarded
drug policy) are subject to the deductible and coinsurance. For a
beneficiary who has already met the deductible, the coinsurance for the
entire 60-mg vial would be $2,280. Since the vial in this example
contains enough drug to provide a 20 mg/m\2\ dose to an individual with
a BSA of 3 m\2\, the full amount of drug labeled on the vial would be
used in a small subset of patients.
As discussed in the CY 2023 PFS proposed rule (87 FR 46055 through
46062), section 90004 of the Infrastructure Investment and Jobs Act
(Pub. L. 117-9, November 15, 2021) (hereinafter is referred to as ``the
Infrastructure Act'') amended section 1847A of the Act to redesignate
subsection (h) as subsection (i) and insert a new subsection (h), which
requires manufacturers to provide a refund to CMS for certain discarded
amounts from a refundable single-dose container or single-use package
drug. The refund amount is the amount of discarded drug that exceeds an
applicable percentage, which is required to be at least 10 percent, of
total charges for the drug in a given calendar quarter. A refundable
single-dose container or single-use package drug does not include a
radiopharmaceutical or imaging agent, certain drugs requiring
filtration, and certain new drugs. We proposed implementation of
section 90004 of the Infrastructure Act including: how discarded
amounts of drugs are determined; a definition of which drugs are
subject to refunds (and exclusions); when and how often CMS will notify
manufacturers of refunds; when and how often payment of refunds from
manufacturers to CMS is required; refund calculation methodology
(including applicable percentages); a dispute resolution process; and
enforcement provisions. We also proposed regulatory changes to
implement new section 1847A(h) of the Act at 42 CFR part 414, subpart
K.
We note, subsequent to the publication of the CY 2023 PFS proposed
rule, sections 11101 and 11102 of the Inflation Reduction Act (IRA)
(Pub. L. 117-169), relating to inflation rebates by manufacturers of
drugs covered under Medicare Parts B and D, were signed into law on
August 16, 2022. These provisions are effective January 1, 2023. We
believe implementation of the Parts B and D rebates mandated under the
IRA should be considered together with the operational implications of
discarded drug refund discussed in this final rule, because the refunds
and rebates both require CMS to accept payments from drug manufacturers
to the Federal Supplementary Medical Insurance (SMI) Trust Fund. In
order to align the operation of these programs and minimize burden, we
are declining to finalize some aspects for collection of discarded drug
refunds. Specifically, we are declining to finalize the timing of the
initial reports and which quarters' information will be included in
each report; this is discussed below in section III.A.4. of this final
rule. We are also declining to finalize specific dates associated with
the dispute resolution process (discussed below in section III.A.7. of
this final rule), which are impacted by the reporting dates. We intend
to address these aspects in future rulemaking.
2. Discarded Amounts
The JW modifier has existed since 2003, and since 2017 its use has
been required on claims for separately payable Part B drugs that
include discarded amounts of single use vials or single use packages.
Currently, there are no other modifiers to measure discarded units of
Part B drugs. On the claim form, the amount of drug administered is
billed on one line (reflected as billing units in the unit field);
discarded amounts are billed on a separate line with the JW modifier
(reflected as billing units in the unit field). The term ``billing
unit'' is defined in section 1847A(b)(6)(B) of the Act as the
identifiable quantity associated with a billing and payment code, as
established by the Secretary. For example, in a circumstance where a
single-dose container is labeled to contain 200 mg and the established
billing unit for the billing and payment code is 2 mg, then there are
100 billing units in the vial. If 95 billing units (190 mg) are
administered to the patient and 5 billing units (10 mg) are discarded,
the 95 billing units are billed on one line, and the discarded 5
billing units are billed on another line using the JW modifier. Both
line items are processed for payment.
The JW modifier must not be used to report discarded amounts of
overfill, which is any amount of drug greater than the amount
identified on FDA-approved labeling. Additional information on the
overfill policy is available in the PFS final rule published in the
November 29, 2010 Federal Register (75 FR 73466 through 70). Contents
of a vial or package that are considered overfill are not included in
the total billing units contained in the vial or package and also do
not count toward the number of billing units that are discarded.
As discussed in the CY 2023 PFS proposed rule (87 FR 46056 through
46058), section 1847A(h) of the Act specifies that discarded amounts of
refundable single-dose container or single-use package drugs are to be
determined using a mechanism such as the JW modifier used as of the
date of enactment of the Infrastructure Act or any successor modifier
that includes such data as determined appropriate by the Secretary. For
consistency with our current billing procedures and to minimize burden,
we proposed to use the JW modifier or any successor modifier that
includes the same data to determine the total number of billing units
of a billing and payment code (that is, the identifiable quantity
associated with a billing and payment code, as established by CMS) of a
refundable single-dose container or single-use package drug (defined in
the next section), if any, that were discarded for dates of service
during such quarter. We
[[Page 69712]]
proposed to use the JW modifier (or any successor modifier that
includes the same data) to identify discarded billing units of a
billing and payment code for the purpose of calculating the refund
amount as described in section 1847A(h)(3) of the Act.
We explained, currently under the OPPS and Ambulatory Surgical
Center (ASC) Payment System, hospital outpatient departments (HOPDs)
and ASCs use the JW modifier to identify all separately payable drugs
and biologicals for which there is an unused or discarded amount. For
consistency with our current billing procedures we proposed that HOPDs
would be required to report the JW modifier or any successor modifier
to identify discarded amounts of refundable single-dose container or
single-use package drugs described by HCPCS codes that are assigned
status indicator ``K'' (Nonpass-Through Drugs and Nonimplantable
Biologicals, Including Therapeutic Radiopharmaceuticals) or status
indicator ``G'' (Pass-Through Drugs and Biologicals) under the OPPS.
Specifically, we proposed that the JW modifier would be used to
determine the total number of billing units of the HCPCS code (that is,
the identifiable quantity associated with a HCPCS code, as established
by CMS) of a refundable single-dose container or single-use package
drug (defined in the next section), if any, assigned status indicator
``K'' or ``G'' that were discarded for dates of service during such
quarter for the purpose of calculating the refund amount described in
section 1847A(h)(3) of the Act. Similarly, we proposed that ASCs would
be required to report the JW modifier or any successor modifier to
identify discarded amounts of refundable single-dose container or
single-use package drugs described by HCPCS codes assigned payment
indicator ``K2'' ('Drugs and biologicals paid separately when provided
integral to a surgical procedure on ASC list; payment based on OPPS
rate) under the ASC payment system. Specifically, we proposed that ASCs
would be required to report the JW modifier or any successor modifier
that includes the same data to determine the total number of billing
units of the HCPCS code (that is, the identifiable quantity associated
with a HCPCS code, as established by CMS) of a refundable single-dose
container or single-use package drug (defined in the next section), if
any, assigned status indicator ``K2'' that were discarded for dates of
service during such quarter.
Consistent with section 1847A(h)(1)(C) of the Act, which excludes
units that are packaged into the payment amount for an item or service
and not separately payable, as well as current HOPD and ASC use of the
JW modifier, we proposed that the JW modifier would not be required to
identify discarded amounts of drugs that are not separately payable,
such as drugs for which payment is packaged under the OPPS or ASC
payment system or drugs administered in the FQHC or RHC setting.
Specifically, in HOPD setting and the ASC setting, the JW modifier does
not apply to drugs that are described by HCPCS codes assigned status
indicator ``N'' (Items and Services Packaged into APC Rates) under the
OPPS or assigned to a payment indicator of ``N1'' (Packaged service/
item; no separate payment made) under the ASC payment system.
Similarly, we proposed to exclude from the refund amount those
units of drugs for which payment is packaged into payment for a
comprehensive ambulatory payment classification (C-APC) service under
the OPPS. We proposed to exclude such drugs when payment is packaged
into a C-APC service which is assigned to an OPPS status indicator of
``J1'' (Hospital Part B Services Paid Through a Comprehensive APC) or
``J2'' (Hospital Part B Services That May Be Paid Through a
Comprehensive APC). For example, if a drug under the OPPS is assigned
to status indicator ``K'', reports the JW or similar modifier, but is
then packaged into a C-APC service assigned to a status indicator of
``J1'' or ``J2'', we would exclude from the refund those units
associated with the packaged drug.
We stated that section 1847A(h) of the Act requires manufacturers
to provide refunds for discarded amounts of refundable single-dose
container or single-use package drugs for which payment is made under
Part B exceeding an applicable percentage of at least 10 percent of the
estimated total allowed charges for such a drug (less the amount paid
for packaged drugs) during the quarter. Under our current discarded
drug policy, no modifier is required when there are no discarded
amounts from a single-dose container.\140\ However, as discussed in the
proposed rule, we are aware that the JW modifier is often omitted on
claims, and it is unclear whether the absence of the JW modifier on a
claim for a single-dose container drug indicates that there were no
discarded amounts or that the modifier was incorrectly omitted from the
claim. This has led to incomplete data describing quantities of
discarded amounts and the associated Medicare payments. We explained
that there are a number of possible reasons why the modifier might be
incorrectly omitted on the claim form, including provider burden for
documentation or lack of awareness of the policy. In addition, there
may not be strong incentive for appropriate JW modifier use because
Medicare pays for administered and discarded amounts of the drug. For
instance, if a provider administers a portion and discards a portion of
a single-dose container, but bills for the entire vial as administered
(incorrectly omitting the JW modifier), the provider payment and
beneficiary coinsurance amounts would be the same as if the provider
had correctly billed for the administered amounts and the discarded
amounts (using the JW modifier). The JW modifier FAQs state that claims
that do not use the modifier correctly may be subject to review, but we
do not have quantifiable numbers regarding how often the modifier is
omitted or how many discarded units are not accounted for because of
such omissions. Because JW modifier data is incomplete and because
refund amounts would rely on this data, we proposed that for dates of
service on or after January 1, 2023, the JW modifier be required on
claims for all single-dose container or single use drugs for which any
amount is discarded (as reflected in our current policy and proposed
above), and a separate modifier be required on claims for these drugs
when there are no discarded amounts. Specifically, we proposed to
require the use of a separate modifier, the JZ modifier, to attest that
there were no discarded amounts. To align with the JW modifier policy,
the JZ modifier would be required when there are no discarded amounts
from single use vials or single use packages payable under Part B for
which the JW modifier would be required if there were discarded
amounts. So, on all claims for single use vials or single use packages
payable under Part B, either the JW modifier would be used (on a
separate line) to identify any discarded amounts or the JZ modifier (on
the claim line with the administered amount) would be present to attest
that there were no discarded amounts. We noted that we believe the
proposed JZ modifier requirement would not increase burden on the
provider because under the current JW modifier policy, the provider
already needs to determine whether or not there are any discarded units
from a single use vial or package, record discarded amounts in the
patient medical record, and specify
[[Page 69713]]
administered and discarded amounts on the claim form.
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\140\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf.
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We sought comments on the proposals.
The following is a summary of the public comments received on the
discarded amount provisions and our responses:
Comment: Several commenters expressed general support for the
proposed policy. One commenter supported the requirement that
manufacturers refund CMS for drug discards.
Another commenter supported a variety of policies to reduce costs
related to discarded drugs, including the manufacturer refunds for
discards, re-examining the weight-based dosing of drugs, requiring
pharmaceutical companies to have vial sizes that more appropriately
meet the range of standard dosing, developing more multiple-dose vials
that can be shared across multiple patients, and utilizing closed-
system transfer devices to extend beyond-use-dating time. One commenter
stated the proposed policy may result in manufacturers acting to revise
packaging methods and incentivize a reduction in waste across markets
and programs. One commenter expressed their belief that the provision
would reduce waste and spending in Medicare by discouraging
manufacturers from including excessive amounts of drug single-dose
containers. One commenter summarized their own analysis of drug
discards at their facilities, noting that five chemotherapy drugs
accounted for 59 percent of all chemotherapy drug discards, and that
these drugs had discards about 3 to 7 times more than all studied drugs
did on average.
Response: We thank commenters for their support of these proposals.
We also thank commenters for their view on discarded amounts of drugs
and how the proposed policies may incentivize a reduction in spending
on discarded amounts of drugs. We also appreciate the thoughtful
analysis of discarded amounts from the practitioner's perspective. We
agree that the proposed policies will create such incentives for
improved package sizes and presentations of drugs that will reduce
amounts that are discarded.
Comment: Some commenters expressed general opposition to the
implementation of the provision. Two commenters expressed concern that
the proposal will disproportionately impact small biotech companies,
who will either raise prices for patients or reduce research
expenditures. One commenter stated that it is unreasonable to collect
refunds for administration processes that generate discarded drug for
which there are no or limited alternatives. One commenter expressed
concern that the proposed policy would result in larger amounts of
discarded drugs by compelling manufacturers to create more batches of
smaller vials with the intention of reducing drug waste, but with the
unintended consequence of creating more waste and added costs to
undergo the process of retrofitting manufacturing facilities to produce
different vial sizes. The commenter also expressed concern that the
proposed policy would compel providers to spend effort learning how to
administer drugs from new container and package configurations. Some
commenters expressed concern that the proposed policy would increase
operational burden by incentivizing container size reduction, for
example by requiring providers to use more containers than had
previously been needed to achieve an appropriate weight-based dose. Two
commenters stated that the production of medications in multiple vial
sizes would be costly for the manufacturer and inefficient in
production. One commenter noted the cost and time required to develop
and obtain regulatory approval for a new vial size, which they
estimated to be about 2 years and $10 million. The commenter also noted
that there are no assurances that if they gained approval for and
distributed treatment in additional vial sizes to reduce discard
amounts that providers would stock them. The commenter concluded that
the effect of the provision's incentive to use a greater number of vial
sizes would be increased treatment costs.
One commenter requested CMS examine the implications of the
proposals on products commonly used in neurology. The commenter stated
several products commonly used by neurologists are packaged in a way
that results in significant amounts of discarded drug. One commenter
noted concern that, in response to the discarded drug refund policy,
manufacturers may raise the price of certain drugs to compensate for
the cost of any refund payments. The commenter urged CMS to ensure that
implementation is closely monitored, and that appropriate action is
taken to dissuade any manufacturer from compensating for lost revenue
with a price increase.
Response: With regard to commenters that are generally opposed to
the implementation of section 90004 of the Infrastructure Act or
generally opposed to CMS collecting a refund, we do not have discretion
on whether or not to implement the provision. Regarding small biotech
companies being disproportionately affected, we address concerns about
exemptions and unique circumstances in the respective discussions
below. This provision does not include any special treatment
specifically for small biotech companies.
With regard to the increased burden on manufacturers to potentially
manufacture different vial sizes and to providers who would have to
adjust to stocking and administering new vial sizes, we acknowledge
these concerns, but note that the statute requires payment of refunds
for single-dose containers for which the amount discarded exceeds the
applicable percentage. We note that the 2020 data showed that Medicare
Part B spending on discarded drugs is weighted heavily toward a small
number of drug products. With regard to the possibility that the
implementation of the provision could lead to increases in discarded
drug amounts, we do not have any data that suggests this may be the
case. On the contrary, we have seen at least one case in which
discarded amounts of a drug decreased after the manufacturer began
packaging the drug in an additional smaller vial size: Kyprolis[supreg]
(carfilzomib) introduced a 10 mg vial in June 2018 in addition to its
60 and 30 mg vials, and its discard percentages were 14.27 percent in
2017, 12.68 percent in 2018, and 5.95 percent in 2019, suggesting the
new vial size led to a decrease in the discard percentage below 10
percent. In response to the comments that manufacturers may pass on
costs from the investigation and manufacture of new vial sizes, or of
refunds to patients, we do not speculate on drug manufacturer pricing
strategies. We plan to continue to monitor the discarded amounts and
trends with regard to this data; this will be for all drugs payable
under Medicare Part B and not specific to any condition, such as
neurology. We plan to track associated prices of such drugs and assess
discretionary aspects of the policy over time and will undertake
additional rulemaking, if warranted. In addition, as noted above, the
Inflation Reduction Act was signed into law subsequent to the
publication of the CY 2023 PFS proposed rule. Sections 11001 and 11101
establish the Secretary's authority to negotiate prices with drug
manufacturers for select Part B and Part D drugs and require
manufacturers to pay rebates to the Federal SMI Trust Fund for amounts
Part B drug prices exceed inflation-adjusted amounts, respectively.
Comment: One commenter stated that the impact of this new
requirement is unclear and could potentially increase
[[Page 69714]]
the cost of health care delivery, including drug acquisition costs and
overhead and labor costs. The commenter requested we actively monitor
potential downstream outcomes and mitigate any adverse impacts, as
necessary.
Response: We plan to continue engaging with manufacturers as we
implement the drug discard refund provision to ensure we understand how
implementation affects operations, pricing, and costs of healthcare
delivery. In addition, section 1847A(h)(9) of the Act requires OIG to
consult with CMS and FDA and report to several Congressional committees
by November 15, 2024, the impact of this provision on the licensure,
market entry, market retention, or marketing of biosimilar biological
products. We also intend to monitor effects on other drugs and
biologicals impacted by these policies in a similar manner, including
but not limited to the ASP of such drugs and discarded units reported
using the JW modifier. We already review quarterly ASP data for the
calculation of payment allowances, so we will observe trends in the ASP
for drugs subject to refunds.
Comment: One commenter noted the proposal does not account for
discards that occur due to clinical reasons, such as when a physician
reduces the dosage of an administered drug if the patient has a heart
condition or other comorbidities.
Response: Although there may be situations in which there are
increased discarded amounts due to clinical circumstances, there is no
mechanism on a claim to denote discarded units for a change in clinical
circumstance. Section 1847A(h)(3)(B)(i)(I) of the Act requires the
refund amount to be the amount above an applicable percentage of 10
percent of the total allowed charges for a drug. We believe that this
threshold allows for a certain amount of drug to be discarded for
various factors, including clinical reasons, without being subject to a
refund. As we noted above, the most recent JW modifier data indicates
that drugs with discarded amounts exceeding 10 percent is isolated to a
small number of products. There are many drugs provided in single-dose
containers with historical discarded amounts below 10 percent,
including many chemotherapy drugs, which have specific instructions for
reduced dosage in cases of toxicity experienced from the chemotherapy.
For example, ixabepilone dosage is based on BSA and the drug is
provided in a single-dose vial. The dose modifications indicated in the
label direct clinicians to reduce the dose of the drug in certain
clinical situations (the dose reduction could range from 20 to 50
percent depending on the clinical circumstance). Based on the 2020 JW
modifier data,\141\ this drug had just under 8 percent of units
discarded, which is below the applicable percentage of 10 percent, and
the manufacturer would not owe a refund if this data were to be for
dates of service on or after the effective date of January 1, 2023.
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\141\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units/data.
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Comment: Two commenters stated the statutory construction of
section 90004 of the Infrastructure Act requires CMS to define
``unused'' to complete the statute's definition of ``discarded''
referenced in section 1847A(h)(1)(B) of the Act, as the commenters
noted that the two are not interchangeable terms. Several commenters
requested CMS not include in the definition of ``unused'' amounts that
are required to safely administer a drug, such as liquid amounts in a
vial that are needed to assure the appropriate dose is withdrawn into
an injector. These commenters stated that determining discarded amounts
is a two-step process: first that a drug amount was discarded, and
second that the amount did not serve a useful purpose. One commenter
noted that the same interpretation of the term ``unused'' is applied in
the hydrogel example (section III.A.6.a of the CY 2023 PFS proposed
rule (87 FR 46061 through 46062) in the discussion of unique
circumstances) in which we stated that 35 percent would be an
appropriate applicable percentage. Several commenters stated that we
should consider liquid amounts required to express a needle (or that
otherwise gets lost or stuck in the container or administration
devices) and to account for dead volume in the transfer or priming of
drug administration as useful and not as unused or as discards, in
alignment with FDA's thinking on amount of liquid required in vial
fills. Commenters stated these liquid amounts effectuate clinical
outcomes. Another commenter suggested CMS define ``discarded amount
subject to refund'' to exclude amounts left over when the product
contains the minimum fill required for clinicians to draw up the
appropriate labeled therapeutic dose.
One commenter requested that we exclude units administered as part
of a drug's induction or loading dose(s), which are initial dose(s) of
a drug therapy that may differ from the subsequent maintenance dosing
regimen. The commenter stated that induction and loading doses may
involve variable dosing depending on the patient's specific
circumstances. The commenter suggested we use a modifier to identify
such doses in claims. This commenter also requested that we exclude
units of drugs administered in combination with other drug therapies.
The commenter explained that when drugs are used in combination, the
dosing of each drug is likely to vary based on factors such as the
disease/condition being treated and adjustments for potential adverse
events, and it makes little sense to manufacture container sizes to
take all such combinations into account. The commenter added a request
that we establish a claims modifier to identify drugs administered in
combination with others.
Response: As we stated in the proposed rule, when a provider must
discard the amount of drug that was unused (that is, the discarded
amount) from a single-dose container of a drug after administering a
dose to a Medicare beneficiary, the program provides payment for the
unused and discarded amount, as well as the dose administered, up to
the amount of the drug indicated on the vial or package labeling.
We clarify how we interpret ``the amount of such drug that was
unused and discarded,'' with respect to that which should be reported
as discarded based on section 1847A(h)(1)(B) of the Act, as any amount
that is not a part of the dose and is not intended to have a
therapeutic effect in the patient. Even if certain amounts are
extracted from the vial or are required to be in the vial to administer
the prescribed dose, we do not consider them to be used if they are not
intended for therapeutic effect as part of the prescribed dose. This is
contemplated by the statute as evidenced by the exclusion of drugs
requiring filtration during the preparation process as described in
section 1847A(h)(8)(B)(ii) of the Act, and by the treatment of drugs
that have unique circumstances in section 1847A(h)(3)(B)(ii) of the
Act. If the amount of drug lost during filtration was not considered to
be an unused and discarded amount, this exclusion would not be
necessary. Similarly, with regards to the treatment of drugs with
unique circumstances, the statute says the Secretary may, through
notice and comment rulemaking, increase the applicable percentage in
the case of a refundable single-dose container or single-use package
drug that has unique circumstances involving similar loss of product as
that described in section
[[Page 69715]]
1847A(h)(8)(B)(ii) of the Act, which describes the loss due to
filtration. Since the statute prescribes that amounts lost in a manner
similar to filtration during preparation may be considered a unique
circumstance (and may warrant an increased applicable percentage),
these amounts are generally considered unused and discarded for the
purposes of determining discarded amounts. Otherwise, such amounts
would not be required to be billed using the JW modifier, and an
increased applicable percentages would not be needed. Based on this,
generally, we consider the amount that is unused and discarded to be
the labeled amount on the single-dose container (or containers if more
than one is required) minus the dose (the dose being the prescribed
amount of drug).
As examples, we consider labeled amounts remaining in the vial,
amounts remaining in the syringe hub, and amounts remaining in the
syringe that are not a part of the dose intended for therapeutic effect
(as reflected in the product label or that would be reflected on a
provider's prescription for the drug) to be unused and discarded. As
discussed above, such amounts are similar to situations where
filtration is required during preparation, and therefore, are
contemplated by the statute to be unused and discarded amounts. In
addition, we believe that this approach is the simplest for providers
to determine on claims forms and in the medical record.
With regard to the request to exclude units administered as part of
a drug's induction or loading dose and the request to exclude units of
drugs administered in combination with other drug therapies, we
disagree that such discarded amounts as a result of such doses should
be excluded from being reported using the JW modifier, because the
statute allows for a certain amount to be discarded (that is, the
minimum applicable percentage of 10 percent). When an induction or
loading dose is administered, there may subsequently be larger amounts
of drug left in the single-dose container when compared with the amount
of drug left in the container if a typical dose had been administered.
As described above, we consider amounts left in the vial to be unused
and discarded because they were not part of the dose that was intended
for therapeutic effect. We disagree that an additional modifier is
needed to report amounts administered in these circumstances because,
as discussed above, the threshold of an applicable percentage of 10
percent, as required in section 1847A(h)(3)(B)(i)(I) of the Act, allows
for a certain amount of discarded drug. This 10 percent threshold
allows for circumstances when a loading dose or induction dose is
administered, or when a drug is administered in combination with other
drug therapies, before a refund would be required.
Comment: Three commenters supported CMS's proposal to exclude
overfill amounts from being taken into consideration when determining
the number of units that are discarded, but two of these commenters
requested that the regulatory text be updated to clearly reflect this.
The commenters stated that without this clarification, physicians may
mistakenly report overfill amounts as discarded amounts, leading to
inaccurate refund amounts. Commenters stated that while the preamble
and guidance is clear, the regulatory text is confusing because some
providers may interpret a ``billing unit'' to also reference overfill
units. Commenters recommended revisions to the proposed regulatory text
changes at Sec. 414.940(a)(1)(iii) and (c)(1)(i). One commenter
requested clarification about whether providers should report discards
of overfill. One commenter encouraged provider education that the JW
modifier should not be used to report discarded amounts of overfill.
Response: We disagree that changes to the regulatory text are
needed for clarification. As stated in our longstanding JW modifier
FAQs, the JW modifier must not be used to report discarded amounts of
overfill, which is any amount of drug greater than the amount
identified on FDA-approved labeling. We reiterate the overfill policy,
as stated in the CY 2011 PFS final rule (75 FR 73466 through 73470),
that contents of a vial or package that are considered overfill are not
included in the total billing units contained in the vial or package,
and also do not count toward the number of billing units that are
discarded.
Comment: Two commenters requested that we clarify that drug discard
refunds under section 1847A(h) of the Act are excluded from ASP,
average manufacturer price (AMP), and the Medicaid best price
calculations.
Response: We do not consider the discarded drug refund to be a
price concession that is described in section 1927 of the Act. Since
these Part B refunds represent reimbursement by manufacturers to
Medicare for a discarded amount that is ``otherwise unsalable returned
goods'' manufacturers may exclude these Part B discarded drug refunds
from determinations of best price and AMP (including 5i AMP). Section
1927(k)(1)(B)(i)(III) of the Act states that AMP shall exclude
reimbursement by manufacturers for recalled, damaged, expired, or
otherwise unsalable returned goods, including (but not limited to)
reimbursement for the cost of the goods and any reimbursement of costs
associated with return goods handling and processing. We implemented
this statutory language in regulations for the determination of AMP
(see 42 CFR 447.504(c)(16) and (e)(7)), and the determination of best
price (see Sec. 447.505(c)(14)).
We note that manufacturers typically have established internal
policies regarding returned purchases, and to the extent that the
reimbursement by the manufacturer for returned goods is consistent with
the requirements of section 1927 of the Act and applicable federal
regulations, such reimbursement made by the manufacturer shall be
excluded from AMP. Standard industry practices and manufacturer
policies should govern the determination of what is unsalable, provided
such practices are consistent with section 1927 of the Act and
applicable federal regulations. What is ``unsalable'' can vary by the
product, and manufacturers should rely upon prevailing business
standards to determine circumstances when their products are unsalable.
Section 1847A(c)(2)(A) of the Act states that sales exempt from the
inclusion in the determination of Medicaid best price are also excluded
from the calculation the manufacturer's ASP. Since discarded drug
refunds are considered to be ``otherwise unsalable returned goods'' and
manufacturers may exclude discarded drug refunds from determination of
best price, manufacturers may also exclude such refunds from the
calculation of ASP.
Therefore, with regard to the calculation of ASP, AMP, or the
Medicaid best price, the refund amounts may be excluded from such
determinations.
Comment: Several commenters expressed support for our proposal to
require the use of the JZ modifier to attest that there are no
discarded amounts. One of the commenters expressed support for methods
that could increase JW reporting. One commenter expressed support for
our proposal to require institutional providers and ASCs to report the
JW modifier, or any successor, on Part B medication claims.
Response: We thank the commenters for their support. We believe
that the JZ modifier requirement will improve the completeness of the
discarded drug data to effectively implement section 90004 of the
Infrastructure Act.
[[Page 69716]]
Comment: Many commenters opposed our proposal to require the JZ
modifier when no amount is discarded from a single-dose container.
Commenters considered its use unnecessary for documenting discarded
amounts, overly burdensome, and potentially confusing. Commenters
stated that the JW modifier on its own is sufficient to calculate
discarded amounts for drugs and biological products subject to this
provision. A few commenters expressed the belief that providers are
correctly reporting JW modifier data on claims, and that we have no
evidentiary basis for believing our JW data is incomplete. Other
commenters acknowledged that providers sometimes omit the JW modifier,
and suggested several reasons for underreporting, including
administrative resource constraints, the lack of incentives for its
use, and inability to measure discard amounts. One commenter opposed
the requirement to use the JZ modifier on the grounds that the burden
of identifying drugs administered with no discarded amounts should fall
on CMS or manufacturers, rather than the provider.
Response: We disagree with the assertion that the JZ modifier is
unnecessary and that we lack evidence to show that reported JW modifier
data fails to convey a full account of drug discard data. The National
Academies of Sciences, Engineering, and Medicine provided an analysis
conducted by the Committee on Implications of Discarded Weight-Based
Drugs \142\ which indicates low compliance with the JW modifier
requirement. Their analysis of Medicare claims found that the level of
compliance is variable among providers, and that nearly two-thirds
never used the modifier at all. In addition, providers who use the
modifier do not do so consistently, and they vary in their reporting
from one drug to another, and across claims for the same patient and
drug. Based on these findings, we believe current data for discarded
drug amounts are underestimates due to omission of the JW modifier when
it should be used, even though reporting the JW modifier has been
required since 2017. Accordingly, we believe that more complete data is
needed. We believe the most practicable method for improving our data
quality is by requiring providers filing claims for drugs from single-
dose containers to report either a JW modifier when there are discarded
amounts, or JZ modifier when no amount is discarded. We continue to
believe providers are the only party that can obtain complete and
accurate information on used and discarded amounts of variably dosed
drugs. While we acknowledge that, in some situations, it may be
difficult to quantify discarded quantities of drugs and associate the
specific amount with a single beneficiary, we believe that, in most
situations, there are no practical impediments that would prevent
billing providers or other staff, such as nurses or pharmacists, from
incorporating the measurement of discard amounts into the process of
preparing and administering the drug. We also believe that the
observation and recording of no discard amounts using the JZ modifier
does not add additional burden beyond the existing requirement of
measuring discarded amounts by use of the JW modifier. If a provider is
already required to determine whether there are discarded amounts from
single-dose packages, then they are already assessing and documenting
what is needed for the JZ modifier. Since the assessment is already
required, the only additional action needed by the provider is to add
JZ on the claim form when there are no discarded amounts. Thus, we
believe the burden for reporting the JZ modifier is minimal and
justifiable.
---------------------------------------------------------------------------
\142\ National Academies of Sciences, Engineering, and Medicine.
2021. Medications in single-dose vials: Implications of discarded
drugs. Washington, DC: The National Academies Press. https://doi.org/10.17226/25911. National Academies of Sciences, Engineering,
and Medicine. 2021. Medications in Single-Dose Vials: Implications
of Discarded Drugs. Washington, DC: The National Academies Press.
https://doi.org/10.17226/25911.
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Comment: Commenters requested that we take care to minimize
administrative burden in the implementation of section 90004 of the
Infrastructure Act, and many suggested several alternatives to the JZ
modifier. Several commenters recommended that we enhance education
efforts and outreach to providers on JW modifier use instead of
requiring the use of the JZ modifier. One commenter requested that we
instead amend our claims policy to state that the absence of reporting
the JW modifier on claims for single-dose containers is an attestation
that there is no amount of discarded drug. Several commenters suggested
we only require JW and JZ modifier use for drugs associated with
significant discards and refund obligations while focusing data
collection efforts on JW data for those drugs. Two commenters
recommended that instead of requiring the use of the JZ modifier, we
develop a new claims modifier for drugs subject to the refund which, in
conjunction with JW modifier data, would produce the information set we
need to issue refund obligations.
Response: As noted above, since the JW modifier is underreported,
the absence of the modifier cannot be relied upon to signify that there
is no amount of discarded drug.
In response to the request that we require the use of the JW and JZ
modifiers only for drugs that are associated with high discard amounts
in recent quarters, or any other subset of separately payable Part B
drugs from single use vials or single use packages, we believe that
approach is likely to lead to confusion among providers and billers,
who may mistake which drugs are included or excluded from the relevant
subset from one quarter to the next. Additionally, we do not see the
practicality of establishing a separate modifier for drugs for which
manufacturers will have refund obligations, particularly as the set of
refundable drugs will likely shift across quarters.
Comment: One commenter stated their current billing software cannot
currently add either the JW or JZ modifier, so under the proposed
modifier requirements for claims covered by the proposed policy,
modifier codes would both have to be handwritten in by non-clinical
staff that smaller facilities cannot afford to recruit. The commenter
added that billing software is space-limited and requested CMS only
require the use of modifiers that provide the most information.
Two commenters stated that the addition of new claims requirements
not paired with increased reimbursement or other incentives would
exacerbate strains on provider resources at a time of staffing
shortages. One commenter expressed concern about the additional
workload collecting discard data would impose on pharmacists and
pharmacy technicians. The commenter requested compensatory
reimbursements for such pharmacists and pharmacy technicians for the
work involved with collecting discard data. In addition, the commenter
urged CMS to adopt a mechanism for calculating discard amounts that can
be incorporated into existing processes and use as much automation as
possible. One commenter requested that we assess administrative impacts
the implementation of section 90004 of the Infrastructure Act will have
on provider practices.
Response: The JW modifier policy has been in place since 2017, and
we are codifying it without change in this final rule. Providers should
currently be reporting the JW modifier on their claims, as well as
documenting the discarded amounts in the beneficiary's medical records.
We understand that providers do not currently have the capability to
accept or report the JZ
[[Page 69717]]
modifier. We expect that a 6-month delay in the requirement to use the
JZ modifier would allow providers sufficient time to incorporate
necessary updates to their claims systems to report JZ data. If a
provider cannot report the JW or JZ modifiers as required by October 1,
2023, they should hold their claims until they are able to do so.
Claims submitted without required modifier data will not be accepted.
If the provider has any other technical issues with submitting the
required modifier data, we expect the provider to work with their
Medicare Administrative Contractor (MAC) on an acceptable approach to
submitting claims.
We also understand that providers and administrative staff spend
substantial time on recordkeeping and submitting claims, and adding
claims requirements without removing requirements of equal burden
places strain on provider practices. However, providers have been
required to identify discarded amounts of drugs from single-dose
containers since 2017, so providers should already have established
processes for making these assessments and recording JW data as
appropriate.
In response to whether a method can be developed by CMS for the
automated calculation of discard amounts, we are not in a position to
know which vial or container size of a drug or biological a physician
has selected for a patient nor the amount that has been discarded. For
assistance in calculating discard amounts, we recommend providers and
billers work with drug manufacturers to develop methods for assessing
discard amounts in the easiest manner.
Comment: One commenter requested clarification on all documentation
elements of our proposal. The commenter expressed concern about
documentation burdens, including documentation that proves that
prepared and administered drug amounts match what was billed, as well
as documentation that reports white-bagged or specialty drugs provided
as patient assistance. The commenter added that this documentation is
done manually.
Response: The JW modifier policy has been in place since 2017, and
we are codifying it without change in this final rule. In the JW
modifier FAQ, it states that the JW modifier policy applies to
providers and suppliers who buy and bill drugs and is intended to track
discarded amounts of drugs that occur as a result of the preparation of
a drug dose for administration to a beneficiary. Also, providers and
suppliers must document the amount of discarded drugs in Medicare
beneficiaries' medical records. The document also states that CMS
expects that providers and suppliers will maintain accurate (medical
and/or dispensing) records for all beneficiaries, as well as accurate
purchasing and inventory records for all drugs that were purchased and
billed to Medicare. General guidance on documentation is available in
MLN Matters SE 1316. Providers and suppliers should also check with the
MAC that processes their Part B drug claims for any additional
information on billing and documentation is available at the local
level.
With regard to the JZ modifier, it must be used on the claim line
with the billing and payment code of the drug when no amounts were
discarded. CMS will not require that the provider note in beneficiary's
medical record when no amounts are discarded. We will update the JW
modifier FAQ document to clarify billing and documentation requirements
consistent with this final rule.
With regard to documentation for ``white bagged'' or specialty
drugs that a provider does not purchase, such drugs are not payable
under Part B, are not subject to the JW/JZ modifier policy, and are not
subject to the discarded drug refund.
Comment: Several commenters requested a delay in the requirement to
use the JZ modifier in claims to account for the time needed to
develop, test, and implement changes to claims processing systems, as
well as for provider education and adoption. One commenter requested
the effective date of the provision to be delayed one year, to January
1, 2024, to accommodate software modifications to support the reporting
of the JZ modifier. The commenter stated that it is not realistic to
expect software development and adoption to occur by January 1, 2023.
Several commenters expressed concern that confusion and errors in
use of the JZ modifier by providers may cause billing errors, including
claims denials, and could slow claims processing and provider revenues.
One commenter expressed concern over general risks associated with
noncompliance with the JZ modifier requirement.
One commenter stated providers may experience confusion on correct
JZ modifier use when billing for the administration of generic drugs.
Several commenters urged that we undertake adequate educational
efforts on JW and JZ reporting requirements, including the issuance of
guidance and collaboration with provider communities. Several other
commenters offered to collaborate with us on outreach and education
efforts for the JW and JZ reporting requirements.
Response: We thank the commenters for their feedback and note that
they highlighted several constraints in the implementation of any new
billing and coding elements. After consideration of these comments, we
acknowledge that incorporating the new coding modifier by January 1,
2023 may not be feasible for many providers. Therefore, the JZ modifier
will be effective starting January 1, 2023, but not required until July
1, 2023. For dates of service beginning July 1, 2023 or after,
providers will be required to use the JZ modifier on claims for single-
dose containers when there are no discarded amounts, but CMS will not
perform claims processing edits on its use. Then, beginning October 1,
2023, we will begin edits for correct use of both the JW and JZ
modifiers for billing and payment codes that are required to use the
modifiers based on the policy we are finalizing in this final rule. We
expect this 9-month transition period will allow providers, billing
software vendors, and MACs enough time to adjust billing and claims
review processes before providers are at risk for noncompliance, as CMS
typically posts updates to the Medicare Claims Processing Manual 5
months prior to implementation. Following the publication of this final
rule, we will work to engage providers on claims coding requirements,
including through the Medicare Learning Network, Changes Requests and
associated CMS internet Only Manual sections, and updating the JW
modifier FAQ document \143\ to reflect the new JZ modifier requirement,
and the issuance of technical guidance to MACs. We will take any
opportunity to engage with interested parties to improve our outreach
and education efforts.
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\143\ https://www.cms.gov/medicare/medicare-fee-for-service-
payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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We understand commenters' concerns that confusion about JW and JZ
modifier use could cause compliance issues and, when edits for the
modifies are implemented, delays to provider payments. We expect the
delay in the compliance date for JZ modifier use to July 2023, as well
as the delay in edits for both the JW and JZ modifiers to October 2023,
will give providers time to become familiar with our educational
resources on the new requirement, adopt necessary changes to their
claims processing software, and adjust recordkeeping and billing
practices accordingly.
[[Page 69718]]
In response to the commenter's concern regarding the correct use of
the JZ modifier on claims for the administration of generic drugs, we
are clarifying that we are finalizing the requirement to code either
the JW or JZ modifier on claims for drugs from all single-dose
containers payable under Medicare Part B, regardless of whether the
drug meets the definition of refundable single-dose container or
single-use package drug; this includes both single source and multiple
source drugs. This is consistent with our proposal to align the policy
for the JZ modifier with the current JW modifier policy. That is, the
JZ modifier would be required when there are no discarded amounts from
single use vials or single use packages payable under Part B for which
the JW modifier would be required if there were discarded amounts. As
the requirement to use the JW modifier to report discarded amounts has
been our policy since 2017, we are finalizing in this rule that
providers must report the JW modifier in all outpatient settings
beginning January 1, 2023, but as discussed, we are delaying the
compliance date for the JZ modifier to July 1, 2023. Although we will
only calculate manufacturer refunds with JW modifier data from single
source drugs and biologicals, discarded drug data for drugs that do not
meet the definition of refundable single-dose container or single-use
package drug will provide us with useful information about drug
discards in the Medicare program generally.
Comment: Several commenters requested guidance on appropriate JW
and JZ modifier use. A few inquired about application and proper use of
the modifiers as they relate to claims for drugs that fall under one or
more of the exclusions provided in section 90004 of the Infrastructure
Act, drugs that are packaged for payment, drugs from pre-filled
syringes, ``cellular and/or tissue-based products for skin wounds'',
and drugs from single-dose containers that are used for multiple
patients, as may occur with repackaged or compounded drugs.
One commenter asked how the MACs will process claims that omit both
the JW and JZ modifiers. One commenter requested clarification whether
the billing provider should use the vial size purchased or smallest
vial size available that could have been used to treat the patient as
the basis for calculating discarded amounts. One commenter asked that
we address confusion related to JW modifier policy as stated in MLN
Matters article SE1316, issued August 1, 2013, that discarded drug
amounts reported with the JW modifier ``must correspond with the
smallest dose (vial) available for purchase from the manufacturer(s)
that could provide the appropriate dose for the patient, while
minimizing any wastage.'' The commenter stated that providers have
difficulty identifying what is the smallest dose vial available for
purchase for which they are required to report wastage.
Response: As discussed above, we are finalizing that beginning
January 1, 2023, use of the JW modifier will be required in claims for
all drugs separately payable under Part B that are designated as a
single-dose container on the FDA-approved label or package insert for
which amounts of the drug are discarded. Similarly, beginning no later
than July 1, 2023, the use of the JZ modifier will be required for all
drugs separately payable under Part B that are designated as a single-
dose container on the FDA-approved label or package insert for which
there are no discarded amounts. Claims for drugs subject to this
provision that do not report the JW or JZ modifier on or after July 1,
2023, may be subject to provider audits. Claims that do not report the
modifiers as appropriate on or after October 1, 2023, will be returned
as un-processable until claims are properly resubmitted.
With regard to what vial size should be used to calculate discarded
amounts, discarded amounts should be calculated using the labeled
amount of the product that is actually purchased to prepare the dose,
not the labeled amount of the smallest vial size that could have been
purchased. The guidance referenced in MLN Matters article SE1316 is no
longer effective, as it has been superseded by MLN Matters article
MM9603, which was issued on June 9, 2016, and effective January 1,
2017. This article notified providers of updates to JW modifier
instructions in Claims Processing Manual 100-04, Chapters 17, in which
providers are instructed to use the JW modifier line to bill for
discarded amounts from the single use vial or other single use package
of the drug or biological administered to the patient.
As stated above, we will update our JW modifier FAQ, Change
Requests and associated IOM guidance, and issue a new MLN article, to
reflect the coding changes finalized in this rulemaking.
Comment: One commenter requested direction on how to measure
discard amounts of drugs from small container sizes, such as those with
fill volumes of one mL or less.
Response: As described in the proposed rule, when a provider must
discard the amount of drug that was unused (that is, the discarded
amount) from a single-dose container of a drug after administering a
dose to a Medicare beneficiary, the program provides payment for the
unused and discarded amount, as well as the dose administered, up to
the amount of the drug indicated on the vial or package labeling. We
clarified that above that, generally, we consider the dose (as
described, for example, in the dosage and administration section of the
FDA-approved labeling) as the administered amount and any other amount
as discarded. This applies to determining discarded amounts from all
vial sizes, including vial sizes less than 1 mL. The provider would
bill the number of billing units that represent the dose administered
on one line of the claim form and, on a separate line, bill the number
of billing units of the drug that were discarded. The unused and
discarded amount can be calculated by determining the labeled amount on
the vial and subtracting the dose that was administered to the patient.
Comment: Several commenters stated that the required use of the JZ
modifier contradicts congressional intent in the drafting of this
provision.
Response: We disagree with the commenters. The statute specifies
that we use a mechanism such as the JW modifier to collect data on
discarded amounts. The use of the JZ modifier is consistent with such a
mechanism because it will complement the use of the JW modifier and
will likely increase the accuracy of JW modifier data.
Comment: One commenter requested we extend the requirement to
report discarded drug data with the JW modifier to additional drugs to
obtain more information on discarded amounts and related costs in Parts
B and C. The commenter requested the additional JW data be publicly
reported.
Response: At this time, we are only finalizing that JW and JZ
modifiers be used for billing drug separately payable under Part B that
are designated as a single-dose container on the FDA-approved label or
package insert. Medicare data on Part B discarded amounts is available
at https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units. While we did not consider expanding the scope of discarded drug
reporting in this rulemaking, we look forward to further feedback from
the public on methods to identify and reduce unnecessary costs in the
Medicare program.
After consideration of public comments, we are finalizing our
proposal to codify our existing policy and require that billing
providers report the JW modifier for all separately
[[Page 69719]]
payable drugs with discarded drug amounts from single use vials or
single use packages payable under Part B, beginning January 1, 2023. We
are also finalizing our proposal to require billing providers to report
the JZ modifier for all such drugs with no discarded drug amounts
beginning no later than July 1, 2023, and we will begin claims edits
for both the JW and JZ modifier beginning October 1, 2023.
3. Refundable Single-Dose Container or Single-Use Package Drug
As discussed in the CY 2023 PFS proposed rule (87 FR 46058 through
46059), section 90004 of the Infrastructure Act added section
1847A(h)(8) of the Act, which defines in subparagraph (A) of such
section the term ``refundable single-dose container or single-use
package drug'' as a single source drug or biological (as defined in
section 1847A(c)(6)(D) of the Act) or a biosimilar biological product
(as defined in section 1847A(c)(6)(H) of the Act) for which payment is
made under Part B and that is furnished from a single-dose container.
For the purposes of section 1847A(h) of the Act, we proposed that
the definition of ``refundable single-dose container or single-use
package drug'' would apply to drugs paid under Medicare Part B (that
is, under any payment methodology) that are described as being supplied
in a ``single-dose'' container or ``single-use'' package based on FDA-
approved labeling. This definition also includes drugs described in
FDA-approved labeling as a part of a ``kit'' that is intended for a
single dose or single use. We noted that the JW modifier data published
on the CMS website is limited to only billing and payment codes that
are published on the ASP Drug Pricing File. Therefore, there are likely
billing and payment codes payable under Medicare Part B that would meet
the proposed definition of refundable single-dose container or single-
use package drug that are not found on the ASP drug pricing file or the
JW modifier data published on the CMS website.
We stated that in our analysis of drugs that meet this definition,
there may be a need to revise existing billing and payment codes or
establish a new billing and payment codes for the purposes of
implementing these provisions because estimated total number of units
discarded and total allowed charges must be determined at the billing
and payment code level for the purpose of calculating refund amounts.
For example, if there is a drug that meets the definition of refundable
single-dose container or single-use package drug that does not have a
unique billing and payment code, a new code may be needed for the
purposes of estimating the total number of units that were discarded
during such quarter and the total allowed charges.
We also stated that there may be drugs for which there are national
drug codes (NDCs) of single-dose containers and NDCs of multiple-dose
containers under the same FDA approval, and these NDCs are assigned to
the same billing and payment code. We proposed that for a drug to meet
the definition of ``refundable single-dose container or single-use
package drug,'' all NDCs assigned to the drug's billing and payment
code must be single-dose containers, as described in each product's
labeling.
We explained that section 1847A(h)(8)(B) of the Act specifies that
the term ``refundable single-dose container or single-use package
drug'' excludes drugs that are either radiopharmaceuticals or imaging
agents, drugs that require filtration during the drug preparation
process, and drugs approved on or after the date of enactment of the
Infrastructure Act (that is, November 15, 2021) for which payment under
Part B has been made for fewer than 18 months.
a. Exclusions for Radiopharmaceuticals and Imaging Agents
Section 1847A(h)(8)(B)(i) of the Act excludes a drug or biological
that is either a radiopharmaceutical or an imaging agent. We proposed
to identify radiopharmaceuticals (including therapeutic or diagnostic
radiopharmaceuticals) and imaging agents (including contrast agents)
\144\ for purposes of the exception at section 1847A(h)(8)(B)(i) of the
Act by language describing them as such in FDA-approved labeling.
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\144\ https://www.fda.gov/media/72295/download.
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We proposed to codify the exclusion of radiopharmaceuticals and
imaging agents from the definition of ``refundable single-dose
container or single-use package drug'' at Sec. 414.902.
b. Exclusions for Drugs Requiring Filtration
Section 1847A(h)(8)(B)(ii) of the Act excludes from the definition
of refundable single-dose container or single-use package a drug
approved by FDA for which dosage and administration instructions
included in the labeling require filtration during the drug preparation
process, prior to dilution and administration, and require that any
unused portion of such drug after the filtration process be discarded
after the completion of such filtration process. As the statute states,
for the purposes of this exclusion, the filtration must occur prior to
dilution and administration. Therefore, for example, the definition
excludes those drugs requiring filtration in order to remove the
product from a vial, such as drugs contained within ampules or certain
liposomal products that require filtration when removing the product
from the manufacturer's vial consistent with FDA labeling. However,
drugs that require in-line filters only as part of the drug
administration process would not meet this exclusion. We proposed that,
consistent with section 1847A(h)(8)(B)(ii) of the Act, requirement for
filtration must be present on FDA labeling in order for the drug to be
excluded.
Additionally, consistent with our longstanding interpretation of
the distinction between multiple source drugs and single source drugs
(see program instructions available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), we are
proposing if there is any NDC under a single New Drug Application (NDA)
or Biologics License Application (BLA) that requires filtration as
described in section 1847A(h)(8)(B)(ii) of the Act, then all NDCs of
such drug or biological (that is, any billing and payment code to which
any such NDCs are assigned) would be excluded from the definition of
refundable single-dose container or single-use package drug, even if
other products under the relevant approval and assigned to that billing
and payment code do not require such filtration. We noted that this is
appropriate because drugs and biologicals payable under Medicare Part B
are billed at the level of the billing and payment code (not with the
NDC of the individual product). If some products that require
filtration and some products that do not require filtration are
assigned to the same billing and payment code, we would not be able to
distinguish (based on JW modifier data) which discarded amounts were
from the filtered product and which were from the non-filtered product.
c. Exclusions for Drugs for Which Payment Under Medicare Part B has
Been Made for Fewer Than 18 months
Section 1847A(h)(8)(B)(iii) of the Act excludes from the definition
of refundable single-dose container or single-use package drug approved
by FDA on or after November 15, 2021 and for which payment has been
made under Part B for fewer than 18 months. Typically, if their use is
reasonable and
[[Page 69720]]
necessary and all other coverage requirements are met, FDA-approved
drugs become payable under Medicare Part B on the date which they are
marketed in the United States. However, we are not able to reliably
determine the exact date on which the first Part B claim was paid for a
particular new drug because they are usually first billed using an
unclassified drug or biological billing and payment code. Therefore,
our ability to accurately determine when payment for a new drug has
been made under Part B for 18 months is exceedingly limited. Because of
the operational challenges with identifying the date of when the first
Part B claim was paid for a new drug and because this exclusion would
be operationally difficult to implement if the 18-month period ends in
the middle of a calendar quarter, we noted that we believe it is
appropriate to measure the 18-month period using the first day of the
calendar quarter following the date of first sale as reported to CMS,
which is a required field for reporting ASP data.\145\ That is, for
purposes of this exclusion, we proposed to consider the 18-month period
to begin on the first day of the calendar quarter following the date of
first sale as reported to CMS for the drug. Because 18 months is the
equivalent of 6 calendar quarters, under our proposed approach,
refundable single-dose container or single-use package drugs approved
or licensed by FDA on or after November 15, 2021 would be excluded from
the definition of refundable single-dose container or single-use
package, and thus, not subject to a refund, for the first 6 full
calendar quarters following the date of first sale for any NDCs of such
drug. Thereafter, that is, beginning with dates of service after the
last day of the sixth full sales quarter, the drug would no longer be
excluded from the definition of refundable single-dose container or
single-use package drug. For example, if a drug that would otherwise
meet the definition of refundable single-dose container or single-use
package drug is approved by FDA in June 2023 and the first date of sale
is June 20, 2023, the first day of the calendar quarter following the
date of first sale for such drug would be sales occurring in the third
calendar quarter of 2023 (July 1, 2023 through September 30, 2023), and
we would consider the drug to be excluded from the definition for the
next 6 quarters (that is, through December 31, 2024). As of January 1,
2025, the drug would no longer be excluded from the definition of
refundable single-dose container or single-use package drug and would
be subject to applicable refunds.
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\145\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Downloads/ASP_Data_Collection_Validation_Macro_User_Guide.pdf.
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We proposed that exclusion would apply only once for a drug. That
is, it would apply for the first NDC of such drug assigned to a billing
and payment code and paid under Medicare Part B. If additional NDCs in
the same billing and payment code, such as a new vial size or ready-to-
use syringe, were subsequently approved under the same FDA approved
application (for example, under the same approved NDA or BLA number),
marketed, and paid under Part B, these subsequent NDCs would not start
a new 18-month exception period. We noted that we believe this proposed
approach is appropriate to prevent a drug from periodic or continual
exemption from reports and refunds due to new NDCs that are marketed
under the same FDA-approval.
We proposed to add a new definition at Sec. 414.902 of
``refundable single-dose container or single-use package drug,'' which
would be defined to mean a single source drug or biological or a
biosimilar biological product for which payment is made under this part
and that is furnished from a single-dose container based on FDA-
approved labeling or product information, except as otherwise
specified. We welcomed comment on the proposed implementation of these
statutory exclusions.
The following is a summary of the public comments received on the
refundable single-dose container or single-use package drug provisions
and our responses:
Comment: Several commenters requested CMS add additional exclusions
from this provision for various drugs or drug categories. One commenter
stated that implementation of this provision will likely have
disproportionately negative impacts to small biotech companies that
received FDA approval through expedited development and review
programs. The commenter explained that under expedited programs such as
Breakthrough Therapy Designation (BTD),\146\ it is more challenging for
manufacturers to determine optimal vial size for the purpose of
Medicare payment when focus is primarily on rapid clinical testing. The
commenter stated for breakthrough therapy, the vial size is developed
in a manner that would best match the dosage needed by most trial
participants, while also promoting efficient care delivery. The
commenter stated that in an expedited program using a single vial size
is more efficient from a resource, compliance, and complexity
standpoint. The commenter requested that CMS specifically exclude
products from small biotech companies that received BTD and FDA
Priority Review. The commenter noted that the Inflation Reduction Act
has a similar exception for small biotech companies in its price
negotiation provision.
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\146\ https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.
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Two commenters requested that we exclude orphan drugs because such
drugs have differing manufacturing conditions because of the smaller
scale of demand and production. One of these commenters stated that
failure to exempt orphan drugs from refunds could have the detrimental
effect of stifling innovation and limiting development of new rare
disease treatments that may require weight-based dosing. One commenter
added that even if an orphan drug were produced in multiple vial sizes,
the supply of each vial size may be limited or providers may not stock
all sizes due to the rarity of the condition being treated. One
commenter requested that we exclude all biosimilar biological products.
The commenter stated that they believe this would be justified because
FDA regulations require that biosimilar biologicals have the same
dosage form and packaging as their reference biologicals. In addition,
the commenter noted that biosimilar biological manufacturers cannot
make changes to factors such as vial size that are not first made by
the reference product's manufacturer.
Two commenters requested we exclude all ophthalmic drugs or drugs
with small volumes administered (1 mL or less). Similarly, four
commenters asserted that the exceptions for small vials are necessary
because of unique circumstances. We discuss the unique circumstances of
drugs with small volumes and vial sizes below in section III.A.6.a. of
this final rule.
One commenter requested we establish a unique modifier to signal
the exclusion of drugs administered via ``microdose dispensing.''
Response: We appreciate commenters' insight to the variety of
manufacturers and products that may be affected if a product meets the
definition of refundable single-dose container or single-use package
drug and does not meet a statutory exclusion. The statute defines
refundable single-dose container or single-use package drug broadly,
makes limited exceptions to the definition, and directs the use of JW
[[Page 69721]]
modifier or similar mechanism to calculate the refunds owed. Drugs with
BTD and FDA priority review and ophthalmic drugs with small vial sizes
are not addressed by any of the statutory exclusions and are thus
subject to the JW and JZ modifier policy. This JW modifier data will be
used to calculate refund obligations as required by statute.
Comment: One commenter suggested CMS consider excluding any off-
label use of applicable drugs from the annual report and calculations
of the discarded drug refund, because off-label use could involve
significantly different dosing that varies greatly from the tailored
vial size that was designed for the labeled indication(s).
Response: When a provider bills for a drug, it is reported using
the drug's billing and payment code, which does not allow for
particular designation regarding the indication (or whether the drug
was used off-label). Therefore, there is no way to indicate on a claim
that a drug from a single-dose container was used for an off-label use.
Thus, the drug would still be subject to the JW and JZ modifier policy
and that JW data would be used to determine refund obligations.
Comment: One commenter stated that the discarded drug provision may
interrupt access for some patients to certain treatments. This
commenter stated that CMS should allow manufacturers additional time to
comply with the provision to prevent supply interruptions, and
suggested that CMS should temporarily exempt manufacturers from the
refund while they develop new vial sizes for approval by the FDA. The
commenter also suggested that CMS develop a process for exemption
requests and the provision of temporary relief from compliance for the
requesting party. In addition, the commenter suggested that CMS seek
comment on other drug exceptions to the provision, such as when
compliance would negatively impact patient access.
One commenter requested CMS consider a broader, transparent
exemption policy that would consider the wide range of reasons for
which certain amounts of product may be unused (for example, an
interrupted procedure, changes in clinical circumstance), including a
detailed exemption request process. The commenter recommended that CMS
strike a balance in providing exclusions to allow provider discretion
when additional drug is needed.
Response: CMS does not have discretion to delay the effective date
of this provision, and therefore, cannot allow for an alternative
effective date. As stated above, the statute defines refundable single-
dose container or single-use package drug broadly, makes limited
exceptions to the definition, and directs the use of JW modifier to
calculate the refunds owed. We are not considering an exemption policy
at this time outside of the exclusions specified in statute. We have
discretion, under the statute, to consider unique circumstances and
increased applicable percentages, which are discussed further below.
Comment: Several commenters stated that the proposed rule
inappropriately applies the provision to drugs administered in hospital
outpatient departments and ambulatory surgical centers, which would
cause inappropriate refund obligations. In support of this argument,
the commenters stated that the provision was placed within, and the
statutory language only references calculations and payments under,
section 1847A of the Act and does not reference section 1833(t) of the
Act. These commenters stated that the lack of reference to payments
under section 1833(t) of the Act precludes counting units paid under
the OPPS or ASC payment system. One commenter stated the application of
this provision is particularly inappropriate if future cuts to hospital
reimbursement for 340B drugs are implemented. One commenter expressed
concern about the possibility of an overlap between refunds calculated
under this provision and discounts made available to covered 340B
entities. The commenter asked CMS to develop a policy or process to
ensure such layered price concessions do not occur, which could be done
by stating that OPPS units are not included in the discarded drug
refund calculation.
Response: New section 1847A(h)(2) of the Act requires the
manufacturer of a refundable single-dose container or single-use
package drug to provide to the Secretary a refund that is equal to the
amount specified in paragraph (3). Section 1847A(h)(8)(A) of the Act
defines a refundable single-dose container or single use package drug
for which a refund is owed as a single source drug or biological or a
biosimilar biological product ``for which payment is made under this
part'' meaning Medicare Part B. Payment is made for drugs furnished in
hospital outpatient departments and ASCs under Medicare Part B. See
section 1841(g) of the Act; see also section 1847A(h)(1)(A) of the Act
(requiring use of a mechanism, such as the JW modifier, which applies
to OPPS and ASC drugs, to determine the total number of units).
We also note that section 1847A(h)(1)(C) of the Act excludes
``units that are packaged into the payment amount'' from the refund
calculation. This language also suggests that manufacturers are
required to pay refunds for OPPS and ASC drugs by excluding packaged
drugs, which is a common phenomenon under the OPPS and ASC payment
system. Regarding the commenter's concern about future reductions in
OPPS payment for 340B drugs, we note that, for CY 2023, we are
finalizing a policy to pay for separately payable drugs at a default
rate that is generally ASP plus 6 percent under the OPPS, regardless of
whether a drug is acquired under the 340B program.
Therefore, we are finalizing our proposal that HOPDs would be
required to report the JW modifier or any successor modifier to
identify discarded amounts of refundable single-dose container or
single-use package drugs described by HCPCS codes that are assigned
status indicator ``K'' (Nonpass-Through Drugs and Nonimplantable
Biologicals, Including Therapeutic Radiopharmaceuticals) or status
indicator ``G'' (Pass-Through Drugs and Biologicals) under the OPPS. We
are finalizing that ASCs would be required to report the JW modifier or
any successor modifier to identify discarded amounts of refundable
single-dose container or single-use package drugs described by HCPCS
codes assigned payment indicator ``K2'' (Drugs and biologicals paid
separately when provided integral to a surgical procedure on ASC list;
payment based on OPPS rate) under the ASC payment system. We are
finalizing that the JW modifier would not be required to identify
discarded amounts of drugs that are not separately payable, such as
drugs for which payment is packaged under the OPPS or ASC payment
system or drugs administered in the FQHC or RHC setting.
Comment: One commenter requested that CMS clarify that the
definition of refundable single-dose container or single-use package
drug does not apply to vaccines described in section 1861(s)(10) of the
Act. The commenter explained that the payment amount of those vaccines
is not determined under section 1847A of the Act, and that section
1847A of the Act is explicitly limited to payment for drugs and
biologicals described in section 1842(o)(1)(C) of the Act, which
explicitly excludes vaccines described in section 1861(s)(10)(A) or (B)
of the Act.
Response: CMS grounds its interpretation of this provision on
language in new section 1847A(h) of the
[[Page 69722]]
Act that refunds are owed on refundable single-dose container or
single-use package drugs which are or drugs ``for which payment is made
under this part,'' which would include vaccines described in section
1861(s)(10) of the Act. However, we discuss below that we are
finalizing that for a drug to meet the definition of ``refundable
single-dose container or single-use package drug,'' all NDCs assigned
to the drug's billing and payment code must be single-dose, as
described in each product's labeling. Many vaccines in section
1861(s)(10) of the Act are available in both single-dose containers
(usually prefilled syringes) and multiple-dose containers, and
therefore, would not meet the definition of ``refundable single-dose
container or single-use package drug''.
In addition, we clarify that, with regard to the JW/JZ modifier
policy, we will not require those modifiers for vaccines described
under section 1861(s)(10) of the Act that are furnished from single-
dose containers. Since the influenza, pneumococcal, and COVID-19
vaccines specified in section 1861(s)(10) of the Act are often roster
billed by mass immunizers, and roster billing cannot accommodate
modifiers, it would be impractical to require the JW and JZ modifiers
for such vaccines. Such a requirement would likely result in
substantial operational issues for mass immunizers and impair patient
access to these vaccines. In addition, section 1847A(h)(1)(A)(i) of the
Act describes that data reported by a claims modifier, such as the JW
modifier, are the appropriate measure for determining discarded
amounts. Since such vaccines would not be subject to the JW and JZ
modifier policy, we would not expect to have discarded amount data for
these billing and payment codes for the purposes of calculating the
discarded drug refund.
Comment: Two commenters requested we exempt drugs paid for under
the End-Stage Renal Disease (ESRD) bundled payment. One commenter
expressed concern regarding how implementation of the discarded drug
refund might inadvertently impact ESRD products, including those used
by home dialysis patients (for example, Extraneal, a peritoneal
dialysis solution). The commenter noted the language in the proposed
rule provided a limited number of examples of drugs that are not
separately payable (for example, drugs for which payment is packaged
under the OPPS or ASC payment system or drugs administered in the FQHC
or RHC settings). The commenter requested that we clarify that this is
not an exhaustive list and that drugs for which payment is packaged
under the Medicare ESRD Prospective Payment System (PPS) is another
example of drugs that are not separately payable and are, therefore,
excluded.
Response: We agree with the commenter and clarify that units for
drugs that are packaged under the Medicare ESRD PPS are not subject to
the JW modifier policy or the discarded drug refund.
Comment: One commenter requested clarification on whether
``cellular and/or tissue-based products for skin wounds'' are subject
to the provisions in section 90004 of the Infrastructure Act.
Response: If a product is a single source drug or biological for
which payment is made under Medicare Part B (including any items,
services, supplies, or products that are paid under Medicare Part B as
a drug or biological), is from a single-dose container based on the
FDA-approved labeling or product information, and is not otherwise
excluded, then it meets the definition of refundable single-dose
container or single-use package drug. If the product is also subject to
billing using the JW and JZ modifier as described above, this data will
be used to calculate refund obligations. Therefore, if a product is a
single source drug or biological as defined in section 1847A(c)(6)(D)
of the Act and meets these other requirements, then it is subject to
the refund obligations under this provision.
Comment: One commenter requested that if we finalize the proposal
to create new billing and payment codes for circumstances in which a
billing and payment code today is assigned to both single-dose and
multiple-dose containers, we only create new billing and payment codes
that include products that meet the 10 percent threshold, or a 5
percent threshold, to minimize administrative and billing disruption
and workload. According to the commenter, many shared billing and
payment codes that include a single-dose container are associated with
less than 1 percent discard each year. The commenter also expressed
concern that creating new billing and payment codes in these
circumstances would create challenges determining ``who is
responsible,'' in addition to issues related to ASP calculations and
pricing.
Response: We stated in the proposed rule that there may be a
circumstance in which we need to revise existing billing and payment
codes or establish a new billing and payment codes for the purposes of
implementing these provisions because estimated total number of units
discarded and total allowed charges must be determined at the billing
and payment code level for the purpose of calculating refund amounts.
This statement was separate and apart from our proposal that for a drug
to meet the definition of ``refundable single-dose container or single-
use package drug,'' all NDCs assigned to the drug's billing and payment
code must be single-dose, as described in each product's labeling. As
we discussed in the proposed rule, if there is a drug that meets the
definition of refundable single-dose container or single-use package
drug and does not have a unique billing and payment code by which the
discarded units can be tracked for the purposes of the refund
calculation, we may revise a code or create a new code for the drug.
Comment: One commenter disagreed with our proposal to only include
billing codes for which all NDCs are single-dose containers because in
some circumstances, a manufacturer may sell predominantly single-dose
containers and some, but very few, multiple-dose containers of a drug.
The commenter stated that we instead include single-dose containers
that are in billing codes that contain multiple-dose containers, and
proposed that, since Medicare Part B does not bill drugs by NDC, we
should instead calculate the refund by using: 10 percent of total
charges for the billing and payment code (including all utilization
regardless of whether single-dose or multiple-dose NDCs) or 10 percent
of total charges for single-dose container NDCs in the billing code
(based on the presence of JW or JZ modifiers).
Response: We thank the commenter for their input regarding billing
and payment codes to which both single-dose and multiple-dose
containers are crosswalked. There are several operational challenges to
applying the discarded drug refund to such billing and payment codes.
Since the JW modifier would not be required for the multiple-dose
product, the percentage of units discarded for the billing and payment
code as a whole would be skewed. If a multiple-dose product is included
in a billing and payment code along with single-dose products, there
will be an underestimate for the percent discarded from the single-dose
products. For example, if 100 billing units of the drug from a
multiple-dose vial were billed under a billing and payment code and 100
billing units of the drug from the single-dose vial were billed under
the same billing and payment code, but some was discarded (for example,
70 units administered and 30 units discarded and billed using the JW
modifier), then the percentage discarded overall for the billing and
payment code would be 15 percent. We
[[Page 69723]]
are not able to distinguish billing units from multiple- or single-dose
containers on claims when they are assigned to the same billing and
payment code.
Based on our analysis of JW modifier data from CY 2020, we did not
identify any billing and payment codes that have both multiple-dose and
single-dose containers crosswalked to it for which 10 percent or more
of billed amounts were discarded. Therefore, we believe this
circumstance would not be common and we are finalizing that, for a drug
to meet the definition of ``refundable single-dose container or single-
use package drug,'' all NDCs assigned to the drug's billing and payment
code must be single-dose, as described in each product's labeling.
However, if we find at a later time (particularly with expected
improved data after implementation of the JZ modifier) that several
products are excluded from the definition of refundable single-dose
container or single-use package drug due to a multiple-dose product
being crosswalked to the code, and the manufacturer would otherwise owe
refunds for discarded amounts, we may find it necessary to revisit this
policy in the future.
Comment: Several commenters requested that, if there are drugs
subject to the policy that are not currently found in the public ASP
Drug Pricing File or JW modifier data published on the CMS
website,\147\ that CMS begin publishing ASP and JW modifier data on
those drugs. One commenter requested we publish and update quarterly a
list of all known drugs that fall into a statutory exclusion from the
discarded drug refund process. The commenter expressed concern that the
lack of clarity regarding how CMS will identify excluded drugs may lead
to confusion, and stated that such a publication would allow
manufacturers the opportunity to anticipate valid or erroneous reports.
One commenter requested that CMS issue guidance explaining the
exclusions of drugs from the definition of refundable single-dose
container or single-use package drug, as providers and manufacturers,
particularly in the case of new drugs, may not know whether a drug
falls under one of the exception categories. Another commenter
requested that CMS clarify the process by which we identify excluded
drugs.
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\147\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
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Response: With regard to publishing ASP data, CMS does not publish
an ASP payment limit or crosswalk for all drugs that are reported by
manufacturers. A number of factors, including but not limited to the
setting in which the drug is used and the volume of use in Medicare
Part B, are considered before a decision about national pricing is
made. Since the refunds are determined after claims are submitted and
processed, the specific billing and payment codes that will be subject
to refund obligations will not be known at the time the annual ASP Drug
Pricing File is published. Therefore, the information that would be
required to publish a payment allowance for all drugs subject to the
discarded drug policy would not be available at the time the annual ASP
file is published and, thus, it would not be feasible for CMS to
include that information.
We thank commenters for their input regarding their request that
CMS publish a quarterly list of all known drugs that fall into a
statutory exclusion, and their request for CMS guidance to explain the
exclusion of drugs from the definition of refundable single-dose
container or single-use package drug. We will consider developing lists
of drugs that fit a statutory exclusion as part of the operational
process of implementing this provision.
Comment: Two commenters requested that CMS exclude Part B drugs
that are not administered by the billing supplier, including DME drugs
that are administered by the beneficiary, from the discarded drug
refund. One commenter stated that reporting, audit, and civil money
penalties described in the proposed rule are inappropriate when drug
products are administered outside the chain of custody once in the
possession of the beneficiary. Three commenters requested that we
clarify that drugs administered via an item of DME, and any other drug
billed to the DME MACs, are not subject to the discarded drug refund
provision. Commenters stated that such drugs are typically self-
administered by patient or caregiver in their home, administered over a
period that spans several days, and dispensed by suppliers that have no
visibility into discarded drug provision. They stated that reporting
discarded units in these circumstances would present an increased
burden for all parties involved. One of these commenters requested that
we clarify that drugs whose FDA-approved labels indicate that they are
intended for self-administration by the patient or their caregiver are
not subject to the discarded drug provision. The commenter noted that
this would ensure that the applicability of the discarded drug refund
requirement does not depend on self-administered drug (SAD) list. The
commenter suggested we develop a claims modifier to identify such self-
administered drugs in claims.
Two commenters requested clarification on the application of the JZ
modifier to drugs not administered by the billing supplier, such as
drugs administered via a covered item of DME or those that are self-
administered by patients.
Response: In the proposed rule, we proposed that, to align with the
JW modifier policy, the JZ modifier would be required when there are no
discarded amounts from single use vials or single use packages payable
under Part B for which the JW modifier would be required if there were
discarded amounts.
At this time, we do not believe it would be appropriate to collect
data about discarded amounts from beneficiaries. Section
1847A(h)(1)(A)(i) of the Act describes that data reported by a claims
modifier, such as the JW modifier, are the appropriate measure for
determining discarded amounts. Discarded amounts (as identified by the
JW modifier) are submitted by the billing provider and not the patient,
typically before the patient administers the drug. Therefore, the JW
and JZ modifiers are not required for refundable single-dose container
or single-use package drugs that are self-administered by a patient or
caregiver in the patient's home.
Comment: One commenter expressed support for proposed exclusions
from the discarded drug refund policy. Several commenters expressed
support for the exclusion of radiopharmaceuticals. One commenter noted
approval for our proposal to identify diagnostic and therapeutic
radiopharmaceuticals and imaging agents eligible for the exclusion
based on their FDA-approved labeling. Two commenters requested CMS
explicitly confirm that the exclusion of imaging agents includes
contrast agents.
Two commenters stated that the drug, SusvimoTM
(ranibizumab injection), which is for intravitreal use via ocular
implant, meets the criteria for the filtration exclusion, both with its
ocular implant initial fill and refill-exchange procedure. The drug's
filtration step for the initial fill procedure is described in the
dosage and administration instructions in the label and occurs during
the drug preparation process; filtration occurs prior to dilution and
administration; and the unused portion after filtration is discarded
along with the filtration needle. The commenter stated that, exactly
like the initial fill procedure, the refill-exchange procedure also
includes filtration in a
[[Page 69724]]
manner that is consistent with the filtration exclusion criteria. One
commenter stated that the drug, Onpattro[supreg] (patisiran injection),
meets the criteria for the filtration exclusion. The dosage and
administration instructions in Onpattro's FDA-approved prescribing
information expressly state that the drug must be filtered and diluted
prior to intravenous infusion, and practitioners must discard any
unused portion of the drug after filtration.
With regard to the exclusion for drugs approved by FDA on or after
November 15, 2021 and for which payment has been made under Part B for
fewer than 18 months, three commenters expressed support for this
exclusion. One commenter suggested CMS extend the exclusion by running
the 18-month period from the start of the effective date of this
provision (January 1, 2023) for any new drug with an FDA approval date
on or after July 1, 2021, and creating a data field to collect the
estimated date for Part B reimbursement thereafter for any new drugs
that are approved by the FDA after January 1, 2023. The commenter
stated that this would simplify CMS' burden for monitoring manufacturer
compliance with the new drug exclusion and is consistent with
congressional intent for the grace period for new drugs on the market.
One commenter suggested CMS exclude new drugs for 24 months following
the first sale reported in order to provide adequate time to
operationalize, shift resources, and properly train personnel. The
commenter stated that CMS' proposal to exclude new drugs for 6 calendar
quarters following date of first reported sale does not take into
consideration certain factors, such as the fact that a provider's first
prescription of a new drug is entirely dictated by the needs of the
patient population served. Also, with manufacturers' drug timelines
starting at different points, the health information technology
requirements needed to modify claims may also come at different times.
Response: With regard to the exclusion of radiopharmaceuticals and
imaging agents, we recognize contrast agents as a category of imaging
agents as described in FDA's Guidance for Industry referenced in the
proposed rule.\148\ Therefore, we clarify that contrast agents are
excluded from the definition of refundable single-dose container or
single-use package drug.
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\148\ https://www.fda.gov/media/72295/download.
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With regard to Susvimo and Onpattro and the commenters' assertion
that these drugs are excluded from the definition of refundable single-
dose container or single-use package drug based on filtration steps
described in each drug's FDA-approved labeling, upon review of the
labeling, we agree that both drugs would fit exclusion criteria as
described in section 1847A(h)(8)(B)(ii) of the Act. In both
circumstances, the labeling requires filtration during the drug
preparation process, prior to dilution and administration, and require
that any unused portion of such drug after the filtration process be
discarded after the completion of such filtration process.
With regard to the exclusion for drugs approved by FDA on or after
November 15, 2021, and for which payment has been made under Part B for
fewer than 18 months, we disagree that a data field to collect the
estimated date for Part B payment in the ASP online collection system
is needed. The proposed approach to measure the 18-month period using
the first day of the calendar quarter following the date of first sale
as reported to CMS is adequate for the purposes of measuring when the
18-month period should begin for this exclusion because of the
limitations of identifying the first date for which payment is made
under Part B (as discussed in the proposed rule) and because of the
quarterly nature of the ASP Drug Pricing File publications.
Comment: One commenter requested clarification on the impact to
current billing policy for unused and discarded amounts of the excluded
products specified in statute. The commenter interpreted the exclusion
of certain products to mean that manufacturers are not required to
refund Medicare for the discarded amount of product, though providers
can still bill for the amount discarded using the JW modifier for these
drugs.
Response: We agree with the commenter and clarify that even if a
drug is excluded from the definition of refundable single-dose
container or single-use package drug (and not subject to refunds), for
example, multiple source drugs, claims for such drugs furnished from a
single-dose container are still required to use the JW and JZ modifiers
in accordance with the policy we are finalizing in this final rule. In
addition, as we describe below, although such drugs described in
section 1847A(h)(8)(B)(iii) of the Act are excluded from the definition
of refundable single-dose container or single-use package drugs for an
18-month period of time, we agree with the comment below that providing
information regarding discarded amounts from such drugs would be
beneficial to the manufacturers during the exclusion period. Therefore,
for drugs meeting this time-limited exclusion, we plan to provide
information on the total number of units of the billing and payment
code that were discarded for calendar quarters during the 18-month
exclusion period. Requiring the JW and JZ modifier for all single-dose
container drugs will allow us to provide such information during the
exemption period.
After consideration of the public comments, we are finalizing the
definition of ``refundable single-dose container or single-use package
drug'' as proposed, to be codified at Sec. 414.902.
4. Provision of Information to Manufacturers
In the CY 2023 PFS proposed rule (87 FR 46059 through 46060), we
stated that section 1847A(h)(1) of the Act requires the Secretary to
provide each manufacturer of a refundable single-dose container or
single-use package drug (as defined in section 1847A(h)(8) of the Act)
with a report, for each calendar quarter beginning on or after January
1, 2023, that includes the following information:
The total number of units of the billing and payment code
of such drug, if any, that were discarded during such quarter, as
determined using a mechanism such as the JW modifier used as of the
date of enactment of this subsection (or any such successor modifier
that includes such data as determined appropriate by the Secretary).
The refund amount that the manufacturer is liable for
pursuant to section 1847A(h)(3) of the Act.
We proposed to use the definition of manufacturer at section
1847A(c)(6)(A) of the Act, which is codified at Sec. 414.802 and
defines manufacturer as any entity that is engaged in the following
(this term does not include a wholesale distributor of drugs or a
retail pharmacy licensed under State law):
(1) Production, preparation, propagation, compounding, conversion
or processing of prescription drug products, either directly or
indirectly by extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis.
(2) The packaging, repackaging, labeling, relabeling, or
distribution of prescription drug products.
We proposed to identify the manufacturer responsible for the
provision of refunds by the labeler code of the refundable single-dose
container or single-use package drug. If such product does not have an
NDC, we proposed to use manufacturer
[[Page 69725]]
information included on the ASP data submission for the product.
We proposed that there be a lag between the date of service quarter
and the date we send reports to manufacturers to allow for claims
maturity from the date of service. To operationalize reports to
manufacturers, we must consider the timing with regard to the
availability of JW modifier data. Providers and suppliers have a 12-
month period to submit Medicare Part B claims, including claims for
drugs payable under Part B, so a lag exists between the date of service
when a drug is administered and when the claim is submitted and
adjudicated. Because of this lag in finalized claims, there may also be
a lag in available JW modifier data for any given date of service
quarter. An evaluation of July 2010 Medicare Part B claims in the
Physician/Supplier-Carrier setting showed that 91.68, 96.84, and 98.32,
and 99.13 percent of claims were final at 3, 6, 9, and 12 months,
respectively, following the date of service. At 24 and 48 months, 99.83
and 100 percent of the claims, respectively, were considered to be
final.
We stated that section 1847A(h)(1) of the Act does not specify the
interval by which reports for each calendar quarter must be sent to
manufacturers. We proposed that CMS provide an annual report to
manufacturers with information for each calendar quarter. Sending
reports (with information for each calendar quarter) annually would
reduce the operational resources needed to implement this provision and
would streamline the dispute resolution process. We proposed to send
reports to manufacturers no later than October 1 of each year. We
proposed that the report reflect claims data that is finalized by the
end of the second calendar quarter (that is, June 30) of the year in
which the report is sent. We noted that this would allow time for CMS
to analyze the data and calculate refund amounts to provide reports to
manufacturers no later than October 1. In addition, we proposed that
annual reports would include any additional lagged claims data not
included for the quarters first reflected in the prior year's report.
In an effort to implement this provision in a timely manner, we
proposed to send the first report to manufacturers no later than
October 1, 2023. Under our proposal, this first report would contain
information only for the first calendar quarter of 2023, because that
would be the only quarter for which we would have a substantial amount
of claims data that is finalized by the end of the second calendar
quarter of the year in which the report is sent. We proposed to send
the second annual report no later than October 1, 2024, and this report
would include information for the second, third, and fourth quarters of
2023 and the first calendar quarter of 2024. It also would include any
additional lagged claims for dates of service in the first calendar
quarter of 2023 that were not included in the first report. Subsequent
annual reports would be done in this manner, meaning that they would
provide the information required under section 1847A(h)(1) of the Act
for the last 3 quarters of the prior year, the first quarter of the
current year, and lagged claims data not reflected for the last 3
quarters of the year that is 2 years prior and the first quarter of the
prior year (that is, the quarters first reflected in the previous
year's report). This means that reports (except for those in 2023 and
2024) would include information for 8 calendar quarters: 4 new calendar
quarters and 4 quarters with additional information for claims that
were not yet finalized for those dates of service in the previous
year's report. As proposed, we explained that we would expect to
capture JW modifier data and total allowed charges from over 99 percent
of claims for dates of service in a given quarter. For example, the
report sent to manufacturers in 2025 would include information for
dates of service in the second, third, and fourth quarters of 2024 and
the first quarter of 2025 plus additional lagged claims that were not
included in the report sent in 2024 (that is, information for dates of
service in the second, third, and fourth quarters of 2023 and the first
quarter of 2024).
We noted that when lagged claims data is evaluated, any changes in
the refund amount owed for those quarters and not already accounted for
in the previous year's report would be calculated as described in
section III.A.6. of the proposed rule.
The following is a summary of the public comments received on the
provision of information to manufacturers and our responses:
Comment: One commenter expressed support for the transmittal of
annual reports containing information on discards and refund amounts
for each calendar quarter.
Response: We thank the commenter for their support.
Comment: One commenter requested that we clearly distinguish the
calendar quarter associated with all discard amount claims data.
Response: We thank the commenter for their feedback. The
organization of discarded amount claims data by the date of service
calendar quarter was part of our proposal for the provision of
information to manufacturers. We are finalizing our proposal to send
annual reports to manufacturers containing information described in
section 1847A(h)(1)(A) of the Act, broken down by calendar quarter.
Comment: One commenter requested that we provide quarterly
estimates of projected payment obligations rather than reporting
manufacturer obligations on an annual basis. The commenter expressed
that more frequent notices would help manufacturers better budget their
outlays. Another commenter stated that we should issue preliminary
calculations of refund amounts to manufacturers in order to permit
engagement between CMS and the manufacturer prior to the issuance of
the report.
Response: We appreciate the interest of manufacturers in having
additional advance notice of their refund obligations, and agree with
the commenter that CMS and manufacturers should have time to engage and
address potential disagreements related to discard amounts and refund
calculations before obligations are due. As we discuss below, we are
not finalizing the date we will send the first report to manufacturers
in this final rule and will revisit the timing of the first report to
manufacturers in future rulemaking. However, we believe that it will be
beneficial to provide manufacturers an opportunity to engage with us on
discard amount data in the first year of this provision's
implementation, and therefore, we plan to issue a preliminary report on
estimated discarded amounts based on available claims data from the
first 2 quarters of CY 2023 no later than December 31, 2023. This
preliminary report will not reflect any final determinations of the
number of discarded units, percentage of discarded units, or
calculations of the refund amount obligations. That information will be
sent in the initial report at a date that will be determined through
future rulemaking.
Comment: Several commenters stated that we should provide
manufacturers all information we use to calculate refund amounts to
allow them to validate the accuracy of our calculations, including
claims for all drug units billed to Medicare, along with associated
modifier data. One commenter requested claims-level information be
provided to manufacturers in the annual report, or at the very least,
following the initiation of the dispute process. One commenter
suggested that manufacturers would not be able to engage meaningfully
in the dispute process without seeing claims-
[[Page 69726]]
level data. The commenter cited reasoning related to sharing claims
level data used in 2015 and 2020 Medicaid guidance CMS issued regarding
measures to reduce discount disputes in the 340B program, as well as a
2014 OIG report with the same emphasis.
Response: We agree with commenters that they should have access to
claims information to verify our refund calculations, including number
of allowed claims, allowed charges, amounts administered, and reported
discard amounts, to the extent that they do not violate the privacy of
any beneficiary. Aggregate HCPCS code claims data are available at
https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Part-B-National-Summary-Data-File/Overview. In
addition, aggregate discarded drug data for all separately payable Part
B drugs from single use vials or other single use packages is available
at https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units. Though our proposal only considered including some version of
the aggregated data sets available on those websites in the
manufacturer reports, our aforementioned decision to not finalize the
date we will issue the first reports allows us time to take the request
for claims-level data under advisement. We will consider the inclusion
of claims-level data in manufacturer reports in future rulemaking.
Comment: One commenter requested that the CMS include information
on the use of the JW modifier for drugs approved by FDA on or after the
date of enactment of section 90004 of the Infrastructure Act, and with
respect to which payment has been made under this part for fewer than
18 months drugs in its annual reports to manufacturers while exempting
them from the refund requirement.
Response: Although such drugs described in section
1847A(h)(8)(B)(iii) of the Act are excluded from the definition of
refundable single-dose container or single-use package drugs, we agree
that providing information regarding discarded amounts from such drugs
would be beneficial to the manufacturers during the 18-month exclusion
period. Therefore, we plan to provide information on the total number
of units of the billing and payment code of drugs meeting this
exclusion (and not meeting any other exclusion in section
1847A(h)(8)(B) of the Act) that were discarded during the 18-month
exclusion period.
Comment: One commenter requested that we develop and specify a
mechanism for manufacturers to validate the provider billing practices
underlying reported discarded drug amounts.
Response: The JW modifier FAQ defines discarded amounts as the
amount of a single use vial or other single use package that remains
after administering a dose/quantity of the drug to a Medicare
beneficiary. We clarified this definition above as amounts that remain
after administering a dose/quantity of the drug to a Medicare
beneficiary. We will update our guidance documents to reflect this
definition and we will work with provider groups to guide them to
correctly report discarded amounts.
Comment: One commenter requested CMS review sample data sets,
propose validation mechanisms, and build the infrastructure needed to
implement the provision with minimal risk of error in calculation of
refund amounts.
Response: We thank the commenter for their feedback. We will review
these aspects of implementation and consider these ideas for future
rulemaking.
Comment: Several commenters requested we place a limit on how far
back lagged discarded drug data may be included in the annual report to
manufacturers.
Response: Due to the enactment of the Inflation Reduction Act on
August 16, 2022, and our efforts to efficiently implement two statutory
provisions that require reporting and deposit mechanisms, we are not
finalizing our proposal on the timing of the refund reports, which was
to send the first report to manufacturers no later than October 1,
2023, and subsequent reports no later than October 1 of each year
following. As previously mentioned, the discarded drug refunds are to
be deposited into the Federal SMI Trust Fund. Similarly, the Part B and
Part D rebates described in the Inflation Reduction Act also are to be
deposited into the Federal SMI Trust Fund. We aim to coordinate the
collection of these funds in order to minimize the administrative
burden on both manufacturers and CMS. This requires an alternative
timeline for sending reports to manufacturers and different dates on
which funds would be due and, therefore, we decline to finalize our
proposal that the initial reports under the discarded drug refund
provision to be sent no later than October 1, 2023. In addition, since
the date that the initial report is sent will impact the number of
quarters with mature claims data available, we also decline to finalize
the policy regarding the inclusion of additional lagged data in reports
in this final rule. We will revisit the date of the initial report and
the inclusion of lagged discarded drug data in future rulemaking.
Although we are not finalizing a date for the transmittal of
reports in this final rule, we are finalizing our proposal to send
reports to manufacturers containing discard information for each
calendar quarter on an annual basis. We are also finalizing that we
will send reports to all manufacturers of refundable single-dose
container or single-use package drugs. We intend to address the timing
of these reports in future rulemaking. We also note that we will issue
a preliminary report on estimated discarded amounts based on available
claims data from the first 2 quarters of CY 2023 no later than December
31, 2023.
5. Manufacturer Provision of Refund
As discussed in the CY 2023 PFS proposed rule (87 FR 46060),
section 1847A(h)(2) of the Act states that, for each calendar quarter
beginning on or after January 1, 2023, the manufacturer of a refundable
single-dose container or single-use package drug shall, for such drug,
provide to the Secretary a refund for such quarter. As described in the
previous section, we proposed to issue reports for each calendar
quarter on an annual basis. Section 1847A(h)(4) of the Act states that
refunds under section 1847A(h)(2) of the Act must be paid in regular
intervals as determined appropriate by the Secretary. We proposed that
refunds be paid in 12-month intervals (that is, annually) to align with
the proposal to issue reports for each calendar quarter on an annual
basis. Additionally, we noted that we believe requiring refunds to be
paid on an annual basis is operationally optimal because it allows for
some claims runout while administering reports in a timely manner
following the date of service and leaves more time for dispute
resolution, which we believed would be important for refund calculation
accuracy. Including lagged claims data from the previous year's report
allows more time for claims to be finalized for a given calendar
quarter, consequently represent a more accurate estimate of discarded
units, and result in a more accurate refund calculation. Therefore, we
proposed to specify that the regular interval for the payment of
refunds is annual and that refund amounts for the quarters reported in
an annual report must be paid no later than December 31 of the year in
which the report was sent to the manufacturer except in circumstances
where a dispute is pending. In the case of a dispute,
[[Page 69727]]
payment of the refund is due no later than 30 days after the resolution
of the dispute. As discussed in more detail in the next section, we
noted that we believe December 31 is an appropriate deadline because it
would allow manufacturers to review their annual reports and initiate
dispute resolution if needed. We proposed to require manufacturers
owing refunds to transmit payment in a form and manner specified by
CMS.
We proposed to codify these provisions at Sec. 414.940.
The following is a summary of the public comments received on the
manufacturer provision of refund provisions and our responses:
Comment: One commenter stated manufacturers should have 3 months
after the receipt of the report to remit refund obligations.
Response: We appreciate the commenter's feedback. Our proposal to
issue reports to manufacturers by October 1 and require refund
obligations to be paid by December 31 of the year in which reports are
issued reflects the commenter's preference. However, as stated in the
previous section, we are not finalizing the timing for reports to be
sent or for refund obligations to be paid in this final rule. We will
revisit the process and timeline for manufacturers' provisions of
refunds in future rulemaking. Although we are not finalizing the
proposed timing for reports sent to manufacturers, the effective date
of the provision remains January 1, 2023, as required by statute, and
reports will be sent for calendar quarters beginning on or after this
date.
6. Refund Amount
As discussed in the CY 2023 PFS proposed rule (87 FR 46060 through
46062), section 1847A(h)(3) of the Act provides, with respect to a
refundable single-dose container or single-use package drug of a
manufacturer assigned to a billing and payment code for a calendar
quarter beginning on or after January 1, 2023, that the refund for
which the manufacturer is liable is the amount equal to the estimated
amount (if any) by which:
The product of:
++ The total number of units of the billing and payment code for
such drug that were discarded during such quarter; and
++ The payment limit amount for the refundable single-dose
container or single-use package drug;
Exceeds an amount equal to the applicable percentage of
the estimated total allowed charges for such a drug (less the amount
paid for packaged drugs) during the quarter.
We stated that section 1847A(h)(3) of the Act specifies that the
applicable percentage is 10 percent, but authorizes us to increase this
percentage as appropriate, through notice and comment rulemaking, in
the case of a refundable single-dose container or single-use package
drug that has unique circumstances involving similar loss of product as
that described in section 1847A(h)(8)(B)(ii) of the Act.
We proposed to calculate the refund required under section
1847A(h)(1) of the Act using the number of discarded units for dates of
services in the same calendar quarter to which the payment limit amount
applies. We proposed to estimate the total allowed charges during the
quarter by multiplying the drug's payment limit amount for the quarter
by the total number of units of the billing and payment code of such
drug that were subject to JW modifier reporting including those for
which the JZ modifier would be required if no units were discarded. As
specified in section 1847A(h)(1)(C) of the Act, the total number of
units of the billing and payment code of a refundable single-dose
container paid during a calendar quarter for purposes of subparagraph
(A)(i), and the determination of the estimated total allowed charges
for the drug in the quarter for purposes of paragraph (3)(A)(ii),
exclude such units that are packaged into the payment amount for an
item or service and are not separately payable.
We illustrated how the refund would be calculated, if 2,000 units
of a billing and payment code for a given drug were unused and
discarded during dates of service in the first calendar quarter of
2023, that number would be multiplied by the drug's payment limit
amount for the first calendar quarter of 2023. If the payment limit
amount was $100, that would be multiplied by 2,000 (the number of
discarded units) to equal $200,000. If Medicare paid for 15,000 units
of the billing and payment code subject to the JW modifier with dates
of service in the first quarter of 2023, that would be multiplied by
the same payment limit amount ($100) to determine the total allowed
charges during the quarter ($1,500,000). Then, the applicable
percentage (in this example, 10 percent) of those total allowed charges
($150,000) would be subtracted out to determine the refund amount. For
the sake of this example, that would be $200,000 (the amount described
in section 1847A(h)(3)(A)(i) of the Act) minus $150,000 (the amount
described in section 1847A(h)(3)(A)(ii) of the Act) to equal a refund
amount of $50,000 for the first calendar quarter of 2023.
We noted that section 1847A(h)(3)(A) of the Act states that the
refund amount is equal to an estimated amount, and that the refund
amount is the difference between: (1) the product of the estimated
allowed charges and applicable percentage; and (2) the product of the
total number of discarded units of a drug form a single-dose container
during a given quarter and the payment limit for that drug during that
quarter. Exact amounts are likely not attainable for these numbers
because of, for example, lagged claims data, appeals, or reversals in
the case of an audit. To obtain the most accurate estimates possible,
we proposed to provide information and determine any refund amount for
discarded refundable single-dose container or single-use package drugs
annually, and to include additional lagged claims data not included in
the previous year's report. Based on claims maturity data, we expect
this approach would capture over 99 percent of claims for a given date
of service quarter in an effort to make the most accurate estimates
possible for the purposes of calculating refund amounts. We explained
that if the assessment of lagged claims data increases the refund
amount for a quarter, the manufacturer would be liable for that
additional refund amount, which would be reflected in the report. If
the assessment of lagged claims data decreases the refund amount for a
quarter, we proposed that any overpayment be corrected. In the event
that an assessment of lagged claims data for a calendar quarter causes
the product of total discarded units and the payment limit amount to
fall below the applicable percentage, which would result in no refund
due from that manufacturer for the given quarter, we proposed that any
overpayment be corrected. We solicited comments on the operational
process of overpayment correction.
We proposed to codify these provisions at Sec. 414.940.
a. Increased Applicable Percentage for Drugs With Unique Circumstances
In the CY 2023 PFS proposed rule (87 FR 46061), we stated that
section 1847A(h)(3)(B)(ii) of the Act provides that, in the case of a
refundable single-dose container or single-use package drug that has
unique circumstances involving similar loss of product as that
described in section 1847A(h)(8)(B)(ii) of the Act, the Secretary may
increase the applicable percentage otherwise applicable as determined
appropriate by the Secretary.
We did not propose an increase of the applicable percentage for any
drugs
[[Page 69728]]
with unique circumstances. We noted that we expected that for most
drugs supplied in single-dose containers, the amount of drug indicated
on the vial or container reflects the amount of drug that could
potentially be administered to a patient. This is consistent with FDA
regulations at 21 CFR 201.51(g), which provide that for drugs in
ampules or vials intended for injection, the declaration of net
quantity of contents on the label is considered to express the minimum
quantity of contents and that variation above the stated measure must
comply with the excess volumes set forth in the United States
Pharmacopeia (USP). FDA guidance for industry \149\ explains that USP
General Chapter 1151 Pharmaceutical Dosage Forms provides excess volume
recommendations for mobile and viscous liquids in a range of fill
volumes, noting that the excess volumes recommended are usually
sufficient to permit withdrawal and administration of the labeled
volumes. In this guidance, FDA recommends that single-dose vials should
not contain a significant volume beyond what would be considered a
usual or maximum dose for the expected use of the drug product.
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\149\ https://www.fda.gov/media/88138/download.
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We noted that we recognized there may be very rare cases in which,
as part of a drug's FDA-approved preparation and administration in
labeling, the amount of drug identified on the package or labeling far
exceeds the amount administered to a patient, thus leading to a
substantial percentage of drug that is discarded. For example, in the
case of a drug that is reconstituted with a hydrogel and administered
via ureteral catheter or nephrostomy tube into the kidneys, there is
substantial amount of reconstituted hydrogel that adheres to the vial
wall during preparation.\150\ In this instance, the drug adhering to
the vial wall (and not able to be extracted from the vial) must be
discarded, which leads to a higher percentage of discarded units billed
with the JW modifier. If the labeled amount of the package is 80 mg and
the maximum extracted amount from the vial guarantees delivery of the
maximum dose of 60 mg, then there would be at least 25 percent
discarded units. We noted that in the case that a patient does not
require the maximum dose, the percent of discarded units would be even
higher. In this circumstance, an applicable percentage of 35 percent
may be appropriate because it would allow for the amount drug diluted
in hydrogel that adheres to the vial wall (25 percent) plus an
additional 10 percent to align with the applicable percentage for drugs
without a unique circumstance.
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\150\ https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e.
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We also noted that we considered whether we should adopt a higher
applicable percentage for a drug in this circumstance. We welcomed
comments on specifying a higher applicable percentage for drugs that
are diluted in hydrogel and administered via the pyelocaliceal route,
and we welcome comments on whether an applicable percentage of 35
percent would be appropriate in this circumstance. We welcomed comments
on whether there are other drugs with unique circumstances as described
under section 1847A(h)(3)(B)(ii) of the Act that may warrant an
increase in the applicable percentage.
The following is a summary of the public comments received on the
refund amount provisions and our responses:
Comment: Several commenters supported our proposal to calculate the
refund amount based on claims for each calendar quarter, as well as our
proposal to present aggregate discard information for each quarter.
Commenters stated that using actual claims would capture reductions in
discarded drug amounts due to changes in manufacturers' container or
package configuration.
Response: We thank the commenters for their support.
Comment: Several commenters expressed concern about cases in which
a refund amount would be based on a higher amount than the provider or
supplier was actually paid for the drug or biological. Commenters
requested that we use the actual payment limit used to reimburse
providers and suppliers for each claim to calculate refund amounts,
particularly the 340B ceiling price or the rate drugs are reimbursed in
the event of sequestration.
Response: Section 1847A(h)(3)(A)(i) of the Act states that the
refund amount must be the product of the number of discarded units and
the amount of payment determined under either section 1847A(b)(1)(B) of
the Act in the case of a single source drug or biological product, or
section 1847A(b)(1)(C) of the Act in the case of a biosimilar
biological product. In most cases, the former provides for a payment
limit of 106 percent of the average sales price and the latter provides
for a payment limit of the sum of the average sales price and 6 percent
of the average sales prices of the reference biological product, or 8
percent for qualifying biosimilars during an applicable 5-year period.
These statutory provisions do not account for other payment amounts not
specified in section 1847A(b)(1)(B) or (C) of the Act. We identified an
error in our proposed regulation text, and we are making changes in
this final rule to correct the language in regulation at Sec. 414.940
to reflect payment amounts specified in section 1847A(b)(1)(B) or (C)
of the Act.
Comment: One commenter stated that manufacturers should have the
option of excluding refund claims that are missing data elements such
as provider ID, prescription number, total units billed, or the amount
paid in order to ensure that CMS has verifiable information for the
calculation of refund payments.
Response: We appreciate the commenter's concern about the data
quality used in discard amount and refund calculations. We agree that
claims lacking certain information are unusable for the purposes of
calculating discard and refund amounts and it is important the MACs do
not adjudicate claims that omit those key data elements. Several of the
data elements cited by the commenter, such as the billing provider's
name and National Provider Identifier, the claims service date, HCPCS
code and applicable modifier, and units of service are required and
without which a claim would be returned to the provider. A full list of
data elements institutional providers, physicians, and suppliers must
include on claims submissions can be found in Claims Processing Manual
100-04, Chapters 25 and 26, respectively. Those chapters are available
here at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c25.pdf and https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c26pdf.pdf. In this final
rule we are codifying the requirement to use the JW modifier, which has
been required since 2017, and we are adopting a requirement to use JZ
modifier beginning no later than July 1, 2023. However, several of the
data elements cited by the commenter, such as the amount paid for the
drug in question and the paid date, are populated by a MAC's claims
processing system when a claim is finalized. Other elements cited by
the commenter, such as the prescription number or NDC, are not
necessary for accurate claims processing or the calculation of refund
amounts and are generally not required on a Medicare Part B claim for
payment.
Comment: One commenter requested that we clarify our process for
adjustments to discarded amount and refund calculations after audits
find errors in underlying claims. Another commenter requested that we
clarify our process for reconciling refund
[[Page 69729]]
obligations in subsequent reports to manufacturers after claims from
calendar quarters contained in the previous report have matured.
Response: We recognize that Medicare, through claims audits, may
adjust claims based on audit findings, and this could occur after the
payment of the discarded drug refund. However, since we are not
finalizing the timing for reports to be sent or for refund obligations
to be paid in this final rule, we will revisit the interaction of
claims audits and lagged claims data in future rulemaking.
Comment: One commenter requested that we exclude from the refund
calculation any amounts billed for dually eligible beneficiaries, so
that manufacturers are not required to pay both the discarded drug
refund and rebates under the Medicaid Drug Rebate Program.
Response: Section 1847A(h)(1) of the Act does not exclude units
that are paid for dually eligible beneficiaries that would be subject
to the rebates under the Medicaid Drug Rebate Program.
Comment: With regard to consideration of a unique circumstance in
the case of a drug that is reconstituted with a hydrogel and
administered via ureteral catheter or nephrostomy tube into the
kidneys, several commenters supported increasing the applicable
percentage to 35 percent, because a substantial amount of product
adheres to the vial wall and cannot be extracted from the vial. Many
commenters specifically expressed support for the adoption of an
increased applicable percentage for drugs diluted in hydrogel and
administered via ureteral catheter or nephrostomy tube, specifically
Jelmyto[supreg] (mitomycin for pyelocaliceal solution). Many commenters
requested that CMS finalize a 35 percent applicable percentage
described in the proposed rule's example for Jelmyto[supreg], because
its viscosity makes a portion of the drug stick to the vial wall. One
commenter requested that we consider whether an applicable percentage
greater than 35 percent be applied to such hydrogel products because
providers do not know until drug administration (after the hydrogel has
been prepared by the pharmacy) the value of the patient's kidney
volume, which determines what amount of drug administered.
Response: We thank commenters for their input on the discussion in
the proposed rule about the case discussed in the regarding a drug
reconstituted with a hydrogel and administered via ureteral catheter or
nephrostomy tube into the kidneys, in which there is a substantial
amount of reconstituted hydrogel that adheres to the vial wall during
preparation. We agree with the commenters that such a drug that is
reconstituted with a hydrogel and has variable dosing based on patient-
specific characteristics (for example Jelmyto[supreg] (mitomycin for
pyelocalyceal solution)), should be considered to have a unique
circumstance as described in section 1847A(h)(3)(B)(ii) of the Act that
would warrant an increased applicable percentage. We also thank
commenters for input on whether an applicable percentage of 35 percent
(10 percent applicable percentage plus 25 percent to account for drug
that cannot be extracted from the vial) may be appropriate for such a
drug. We agree with the vast majority of commenters that 35 percent is
a reasonable applicable percentage that would be appropriate in this
case. We disagree that an applicable percentage greater than 35 percent
should be applied to such hydrogel products, because we believe that 35
percent accounts for the hydrogel that adheres to the vial, and because
we have allowed for an additional 10 percent of drug to be discarded
before any refund would be owed.
After consideration of public comments, we are adopting an
increased applicable percentage of 35 percent for drugs reconstituted
with a hydrogel and with variable dosing based on patient-specific
characteristics. At this time, we have only identified one product,
Jelmyto[supreg] (mitomycin for pyelocalyceal solution), that would fit
this unique circumstance.
Comment: Many commenters requested an increased applicable
percentage for certain drugs or certain drug categories that may have
unique circumstances other than the circumstance pertaining to the drug
reconstituted in hydrogel. Several commenters requested that CMS
specify increased applicable percentages for drugs that have highly
variable dosing, such as drugs dosed by patient weight, or skin surface
area, or wound size. One commenter specifically requested an increased
applicable percentage for weight-based drugs, because it is impractical
to manufacture many different vial sizes for such drugs, and even if
mutable vial sizes were available, it would be unreasonable to expect
facilities and pharmacies to keep a broad variety of vial sizes in
stock. One commenter requested that CMS develop a process for examining
each weight-based drug individually in order to determine the
appropriateness of an applicable percentage, and to only include
outlier cases under the discard refund policy.
Another commenter suggested that CMS consider delaying
implementation of a final rule or delay implementation for
reconstituted products in order to evaluate why the provision
disproportionally impacts reconstituted products. The commenter
observed that 9 out of the 10 highest refund examples that CMS
calculated from the 2020 claims data in the proposed rule were
reconstituted products.
Several commenters requested CMS use higher applicable percentages
for drugs packaged with small vial fill amounts or low-volume products
(those less than 1 mL). These commenters noted that, in some cases, the
small volume of drug contained in the vial often represents the minimum
necessary to safely and effectively prepare and administer the target
dose volume. One commenter added that there are practical limits on
providers' ability to measure such small amounts as the basis for
refunds, as well as manufacturers' ability to produce smaller vials to
prevent discarded amounts. One commenter suggested the applicable
percentage of products with small vial fill amounts be product-specific
and calculated using the difference between the labeled amount of
product and the appropriate labeled therapeutic dose for those products
that contain the minimum necessary fill required to draw up the labeled
therapeutic dose. Alternatively, the commenter suggested such products
have an increased applicable percentage, on a sliding scale based on
volume, to account for the increased relative percentage lost in the
vial and syringe with low-volume products. Three commenters requested
100 percent applicable percentage for all products with vial fill
volumes smaller than 1 mL
One commenter stated that although the product,
SusvimoTM (ranibizumab injection), qualifies for the
filtration exclusion, the drug also has a unique circumstance because
of the preparation process, which would justify an applicable
percentage of 80 percent. The commenter explained that, though this
percentage is appropriate because the label instructs that the entire
contents of the vial must be removed to ensure the proper dose is
administered, up to 80 percent of the vial contents are lost in the
process of filtration, removing air bubbles from administration device,
and removing bubbles from the implant. This loss in the preparation and
administration procedure occurs in both the initial fill of the ocular
implant and the refill-exchange procedures. The commenter added that,
because the volume of drug provided in the
[[Page 69730]]
SusvimoTM vial is significantly less than the smallest
packaging recommendations provided in USP General Chapter 1151
Pharmaceutical Dosage Forms, it is not feasible to determine in an
individual case how much volume is discarded after administration other
than by deduction from the labeled instructions and amounts.
One commenter requested an increase applicable percentage for
Dexycu[supreg] (dexamethasone intraocular suspension), because the
entire contents of the vial are mixed with a drug delivery vehicle,
Verisome[supreg], to create a suspended product. The commenter stated
that, because of this process, there is no unused product. In addition,
the commenter stated that this drug has unique circumstances that could
warrant an increased applicable percentage because of the small vial
size with less than 1 mL fill; the viscosity of the suspension created
in the vial resulting in some product adhering to the vial walls; the
minimum depth of material in the vial is needed in order for providers
to be able to pull the product into the 18-gauge needle and the vial;
and that providers' withdrawal 0.2 mL leaves 0.3 mL of contents in the
vial.
One commenter requested an applicable percentage of at least 30
percent for Visudyne[supreg] (verteporfin for injection) on the grounds
that all of the active ingredient is reconstituted and, therefore
``there is no unused product.'' In addition, the commenter stated that
the drug is dosed based on BSA and the package amount is designed to
account for varying body sizes. A 30 percent applicable percentage
would account for the difference between doses for average-sized and
larger individuals. The commenter stated that it is not practical to
create multiple vial sizes.
One commenter requested an applicable percentage of 20 percent for
ElzonrisTM (tagraxofusp-erzs) due to the weight-based nature
of its dosing, the small patient population its treatment is used for
(300 people annually), and because of the leakage inherent in its
storage, distribution, and administration beyond overfill that should
not be considered discarded drug amounts. Another commenter suggested
an increased applicable percentage for Vyvgart[supreg] (efgartigimod
alfa injection) due to its weight-based dosing and required dilution
prior to administration.
One commenter requested an applicable percentage of 70 percent for
Zynrelef[supreg] (bupivacaine and meloxicam solution), a local
anesthetic used in surgical procedures, on the basis of highly variable
dosing based on wound size. The commenter stated that although it
produces multiple vial sizes, providers only stock two vial sizes due
to storage limitations. In addition, providers have difficulty
estimating how much of the product will be needed to cover the area
inside the wound site. The commenter also stated Zynrelef should be
considered to have a unique circumstance because it is a non-opioid
pain management treatment.
Another commenter requested an increased applicable percentage for
eight of its products used for the treatment or care of wounds (ranging
from 23 to 70 percent). The commenter stated that, because wounds come
in an infinite number of sizes, shapes, and depths, it is not possible
to manufacture an individual product sized for each potential wound.
Such products must be tailored to fit the specific wound, and
therefore, there will be discarded amounts every time the product is
used.
One commenter stated that the drug pegcetacoplan, an intravitreal
injection that is under FDA Priority Review, has a 75 percent overfill
amount in the vial due to the high viscosity of the product. They
stated that their scientists determined that this was the appropriate
amount to safely administer the dose amount without air bubbles.
Four commenters requested that CMS utilize its discretion to
increase the threshold for discarded unit refund requirements for cell,
gene, and immunotherapies. Commenters explained that, because these
therapies are unique and need to be given to a patient all at once, the
maximum potentially needed amount of product must be available for each
administration. Therefore, cell and gene therapies should have a 100
percent applicable percentage. Two commenters suggested instructing
providers to use the JZ modifier for all claims for cell and gene
therapy.
Two commenters requested that the applicable percentage for small
biotech companies that received Breakthrough Therapy Designation (BTD)
and FDA Priority Review during the NDA approval process be increased to
30 percent. One commenter requested that CMS establish a review policy
to adjust the applicable percentage for orphan drugs associated with
large discarded amounts.
Two commenters requested that CMS use increased applicable
percentages for products that require complex delivery methods and
necessarily use variable product volume, including those based on the
following factors: mechanisms that deliver drugs to tiny anatomical
spaces of the body, multiple procedures or steps for administration,
variable and unpredictable patient characteristics, specialized
equipment or equipment variability due to physician or facility
preference, and immunogenicity concerns. The commenters requested CMS
base the applicable percentage off of the maximum amount of drug
utilized for successful administration. One commenter added these
techniques often utilize extra product to ensure proper dosage. One
commenter stated products used during complex administration procedures
should be given a 100 percent applicable threshold or be given guidance
to use the JZ modifier.
Several commenters requested that CMS provide a list of criteria
defining unique circumstances that justify an increased applicable
percentage (for example, classes of products, modes of administration,
or disease states) to guide manufacturers. Several commenters requested
that CMS establish a formal process for requesting an increased
applicable percentage based on particular circumstances and
characteristics of their drugs. One commenter stated that such a
process should, at minimum, include subregulatory guidance and
standardized forms that outline the information that CMS deems
necessary in order to assess whether an increased applicable percentage
should be applied. The commenter stated the process should have an
established timeline with deadlines for requests to be included in
proposed rules, consideration of comments on the proposed rule, and the
opportunity to appeal decisions. One commenter stated such a process
would increase transparency and facilitate discussions more effectively
between manufacturers and CMS to assess drugs and their discarded
amounts. Another commenter suggested that, if an administrative process
is developed, CMS do outreach to ensure that manufacturers are aware of
the process and publish guidance on any applicable requirements or
deadlines for submitting a request for an increased applicable
percentage. In addition, one commenter recommended that such a process
should include methods for CMS and manufacturers to consult with
relevant expert agencies and other organizations, including FDA and the
United States Pharmacopeia. One commenter requested CMS take patient
safety into account when considering increased applicable percentages
for variable-dose drugs (for example, regulatory review of new vial
sizes, distribution and inventory constraints for multiple vial sizes).
[[Page 69731]]
Response: We value the input commenters provided and the scope of
drugs that may have unique circumstances. We recognize that there are
products that may indeed have a unique circumstance, and an increased
applicable percentage for these products would have to be determined
through future notice and comment rulemaking as required by the
statutory provision. Therefore, we are not adopting increased
applicable percentage for any additional products in this final rule.
After considering the public comments, we plan to collect additional
information about drugs that may have unique circumstances along with
potential increased applicable percentages that might be appropriate
for each circumstance. We also plan to collect additional information
about a process to identify unique circumstances based on manufacturer
input. We will revisit additional increased applicable percentages for
drugs that have unique circumstances, and a process to identify such
circumstances, through future notice and comment rulemaking.
Comment: One commenter expressed concern that, because they are a
small biotech company, their refund obligation under the proposed rule
would amount to about 10 percent of their net revenue, and that the
refund would have a substantial impact on their capacity for research.
Response: We understand the commenter's concern; however, section
1847A(h) of the Act does not exempt drugs produced by small biotech
companies from the refund requirement. We have discretion in section
1847A(h)(3)(B)(II) of the Act to determine increased applicable
percentages for drugs with unique circumstances involving loss of
product similar to ones that require a filtration process through
notice and comment rulemaking. While we only discussed an increased
applicable percentage for one unique circumstance in the proposed rule
and are finalizing an increased applicable percentage for it in this
final rule, we plan to consider additional unique circumstances in
future rulemaking.
Comment: One commenter requested clarification on the process for
manufacturers of new drugs with unique circumstances to request higher
applicable percentages.
Response: A drug that is exempt from the definition of ``refundable
single-dose container or single-use package drug'' because it was
approved by FDA on or after the date of enactment of the Infrastructure
Act (that is, November 15, 2021), for which payment under Part B has
been made for fewer than 18 months, may still be considered for an
increased applicable percentage for unique circumstances during the 18-
month time period in which the drug is are exempt. We believe that this
would actually be an efficient approach because, when the 18-month time
period has ended (and if the drug otherwise meets the definition of
refundable single-dose container or single-use package drug),
consideration will have already been given to any potential unique
circumstances and any appropriate increases in the applicable
percentage in advance of the refund requirement.
After consideration of the public comments, we are finalizing the
manner in which the refund amount will be calculated as proposed at
Sec. 414.940, with the addition of an increased applicable percentage
of 35 percent for a drug that is reconstituted with a hydrogel and has
variable dosing based on patient-specific characteristics.
7. Dispute Resolution
In the CY 2023 PFS proposed rule (87 FR 46062), we explained that,
as a part of implementing this section 90004 of the Infrastructure Act,
we recognized the need to establish a dispute resolution process
because of the nature of determining the estimated total allowed
charges for a given calendar quarter and the methods by which the
estimated refund amount is determined. Although a dispute resolution
process is not expressly required by section 1847A(h) of the Act, we
noted that we believed proactively establishing such a process will aid
in the successful implementation of this provision. We proposed that
each manufacturer have an opportunity to dispute the report by
submitting an error report as described in this section.
We proposed that to assert that there have been one or more errors
in a report, a manufacturer must submit a dispute with each asserted
error. We proposed that the dispute must include the following
information: (1) Manufacturer name and address; (2) The name, telephone
number, and email address of one or more employees or representatives
of the manufacturer with whom the Secretary may discuss the claimed
errors; (3) For a mathematical calculation error, the specific
calculation element(s) that the manufacturer disputes and its proposed
corrected calculation; and (4) For any other asserted error, an
explanation of the nature of the error, how the error affects the
refund calculation, an explanation of how the manufacturer established
that an error occurred, the proposed correction to the error, and an
explanation of why CMS should use the proposed corrected data.
We proposed that in order to dispute a report, manufacturers must
assert any basis for contesting its refund calculation during the 30-
day period following the issuance of the report. We noted that we would
evaluate error reports and would decide whether the information (such
as number of discarded billing units or refund amount calculation)
requires correction based on the information provided. We proposed that
we would provide manufacturers who have submitted a dispute a response
to each dispute and inform manufacturers of the final refund amount no
later than 30 days after receipt of the dispute. We proposed that if we
find that a different refund amount is owed than what was stated on the
report, we would issue a new report with updated discarded amounts and/
or refund. We proposed that if we disagree with the dispute, we would
notify the manufacturer that refund amount on the report is still owed
and should be paid as described above in section 5 (no later than
December 31 of the year in which the report was sent). We welcomed
comment on whether CMS should develop an appeal mechanism, which we
will consider for future rulemaking.
We proposed to codify the dispute resolution process at Sec.
414.940.
The following is a summary of the public comments received on the
dispute resolution provisions and our responses:
Comment: Several commenters expressed support for our dispute
resolution proposal. One commenter expressed support for its simplicity
and formal character.
Response: We thank the commenters for their support.
Comment: One commenter requested the effective date of the
provision be delayed until after a ``detailed'' dispute resolution
process is implemented.
Response: We do not have the flexibility to delay the effective
date of the provision of January 1, 2023, which is specified in
statute. We may consider an appeal process in future rulemaking.
Comment: Several commenters requested that we broaden the dispute
resolution process to cover disputes related to manufacturer requests
for higher applicable percentages or exclusions for particular drugs.
Commenters offered that we could make these determinations as part of
the annual rulemaking process and that the window for these disputes
could immediately follow the issuance of the final rule.
[[Page 69732]]
Response: We appreciate the commenters' suggestion. At this time,
we are not establishing a separate process for requesting higher
applicable percentages or disputing unique circumstance or applicable
percentage determinations. Since the determination of unique
circumstances or increased applicable percentages requires notice and
comment rulemaking, all interested parties would have an opportunity to
comment on these determinations through the rulemaking process.
Comment: Several commenters requested that the window for
manufacturers to file disputes be extended, with some suggesting an
extension from 30 days to either 60 or 90 days. Several commenters
suggested that, as an alternative to a longer filing window, we provide
manufacturers with preliminary estimates of refund obligations. One
commenter explained that preliminary estimates would be useful in
allowing manufacturers a second opportunity to raise concerns about
discard and refund calculations, which could be of significant help to
manufacturers, since we proposed to include limited information in
manufacturer reports. Commenters stated the proposed timeline does not
allow enough time for engagement with the agency, particularly those
with small regulatory staffs. A few commenters stated that
manufacturers should not have to pay refund obligations when refund
amounts are in dispute, and one requested that they have 90 days after
dispute resolution to remit refund payments.
Several commenters stated that the dispute resolution process
should include an appeal process. One commenter requested an appeals
process overseen by a third-party arbiter. One commenter suggested we
incorporate an appeal process in regulatory text, in order to mirror
the Parts A and B claims appeals process.
Response: We disagree with commenters about the amount of time
needed to file a dispute, and we continue to believe that 30 days is a
sufficient filing period. The information provided in the report is
required by statute to include two numbers: (1) the total number of
units of the billing and payment code of such drug, if any, that were
discarded during such quarter; and (2) the refund amount for which the
manufacturer is liable. We do not expect that the formulation of a
dispute regarding these two numbers should take longer than 30 days,
since the calculations are straightforward. In addition, the 30-day
dispute period is similar to the dispute period for several other CMS
programs. Specifically, many of the Quality Reporting Programs have 30-
day ratings preview periods, including the Quality Payment
Program.\151\ As noted above, we are not finalizing the date that we
will issue the first reports, and we will revisit in future rulemaking
other mechanisms that can ensure that manufacturers have enough time to
process and validate discard data. As stated above, we plan to issue a
preliminary report to manufacturers for the first 2 quarters of 2023 no
later than December 31, 2023. With regard to amounts due while a
dispute is ongoing, as we noted above, we clarify that our intent was
to propose that manufacturers have until 30 days following the
resolution of the dispute to pay the refund if dispute resolution
results in an amount due, which was included in another part of the
proposed rule. We are finalizing this payment deadline for disputed
amounts.
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We thank the commenters for their feedback on the potential
benefits and structure of an appeals process. We will take this input
under advisement and we plan to revisit the topic in future rulemaking.
Comment: Commenters offered several suggestions and requests
regarding the operational aspects of the dispute resolution process.
One commenter requested that the dispute process be simple and easy to
for manufacturers to use. One commenter had several suggestions on the
process operations, including that we permit manufacturers to dispute
as many errors as needed in each dispute, rather than having to file
separate disputes. The commenter also suggested that the process be
conducted through a web-based portal, that we employ dedicated staff to
administer the dispute resolution process, and that we issue program
instruction on the dispute process, including information on factors we
consider in evaluating disputes. Several commenters requested that we
state that the dispute resolution process is confidential, so that no
manufacturer's confidential proprietary information is disclosed to the
public. One commenter requested that we clarify that we will credit
manufacturers in refund calculations in the case of disputes resolved
in a manufacturer's favor. One commenter requested that we remain
engaged with stakeholders while developing the dispute resolution
process.
Response: We agree that the dispute process should be simple and of
minimal burden on manufacturers, and to that end, we will build as much
as possible on data sets already familiar to the public. We will
further address the dispute resolution process in future rulemaking.
With regard to the number of errors that a manufacturer may submit in
one filing, we clarify that we did not propose a limit; we proposed
that a manufacturer would be able to identify as many errors as they
need for each manufacturer report that they dispute. Should a
manufacturer receive two reports for two drugs and the manufacturer
would like to dispute both, the manufacturer would need to file two
disputes, regardless of how many errors they identify in each. We
believe that this aligns with the commenter's request. We would
maintain the confidentiality of a manufacturer's proprietary
information consistent with applicable law.
At the conclusion of the process, if we agree that information
presented by the manufacturer reveals errors in our original refund
calculation, we will make appropriate adjustments to our calculation
and issue a new report to the manufacturer. A report may indicate
either that the manufacturer owes no refund obligation, or some amount
that would be due to the agency within 30 days of the dispute
resolution. If we conclude that information submitted in the dispute
does not affect our original calculation, the manufacturer would owe
the amount specified in the original manufacturer report within 30 days
of the dispute resolution.
We welcome continued engagement with commenters on all aspects of
the dispute process.
After consideration of public comments, we are finalizing our
proposal to establish a dispute resolution process through which
manufacturers can challenge refund calculations and underlying data in
their section 1847A(h)(1)(A) of the Act manufacturer reports in Sec.
414.940(d). We are finalizing that manufacturers will have 30 days
after receipt to file a dispute of their report or reports and that, if
following resolution of the dispute we affirm our original calculation,
or if we resolve to issue a revised manufacturer report that specifies
a new discard refund amount, the manufacturer will be required to pay
the refund within 30 days of the dispute resolution. We are not
finalizing the payment of the refund by December 31 of the year the
report was issued, since we will be revisiting the timing of reports in
future rulemaking. We will also revisit the issue of an appeals process
in future rulemaking.
[[Page 69733]]
8. Enforcement
a. Audits
As discussed in the CY 2023 PFS proposed rule (87 FR 46062),
section 1847A(h)(6)(A)(i) of the Act requires that we perform periodic
audits on each manufacturer of a refundable single-dose container or
single-use package drug that is required to provide a refund under
section 1847A(h) of the Act with respect to such drug and such refunds.
We proposed to specify at 414.940(e) that we periodically audit
manufacturers of refundable single-dose container or single-use package
drugs consistent with this requirement. We welcomed comments about what
such audits should entail, which we will consider for future
rulemaking.
We stated that section 1847A(h)(6)(A)(ii) of the Act requires us to
conduct periodic audits of claims submitted under Medicare Part B with
respect to refundable single-dose container or single-use package drugs
in accordance with the authority under section 1833(e) of the Act.
Under the JW modifier policy, claims for dates of service on or after
January 1, 2017 containing billing for discarded drugs that do not use
the JW modifier may be subject to review.\152\ We proposed that our
review contractors would periodically review Part B medication claims
to ensure the JW modifier, JZ modifier (if adopted), and discarded drug
amounts are billed appropriately consistent with our normal claims
audit policies and protocols.
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b. Civil Money Penalty
We noted that provisions in section 1847A(h)(6)(B) of the Act give
the Secretary authority to impose a civil money penalty on a
manufacturer of a refundable single-dose container or single-use
package drug who fails to comply with the requirement under section
1847A(h)(2) of the Act for such drug for a calendar quarter.
As set forth in section 1847A(h)(6)(B) of the Act, the civil money
penalty would be an amount equal to the sum of--
The amount that the manufacturer would have paid under
such paragraph with respect to such drug for such quarter; and
25 percent of such amount.
We proposed to codify the civil money penalty at Sec. 414.940.
The following is a summary of the public comments received on the
enforcement provisions and our responses:
Comment: Several commenters requested that the focus of
manufacturer audits be limited to the manufacturers' responsibilities
under section 1847A(h) of the Act, namely, the payment of obligations
specified in CMS reports to manufacturers. The commenters also
requested that the audits only be triggered by patterns of unusual
payments, rather than being regularly scheduled. One commenter
requested we engage with manufacturers as we develop the manufacturer
audit process, and that we develop a system that is transparent,
predictable, and minimally burdensome. The commenter requested a 60-day
notice in advance of audits and that we provide instructions on the
audit process and remedial measures. Several commenters requested more
information on the lookback period, frequency, and scope of
manufacturer audits, as well as remedial measures.
One commenter requested that manufacturer audits be performed
remotely.
Response: We agree with the commenters, and at this time, we do not
intend to conduct audits under section 1847A(h)(6)(A) of the Act beyond
determinations they have either paid refund obligations or not. The
remedial measure for nonpayment of refund obligations is the civil
money penalty specified under section 1847A(h)(6)(B) of the Act, as
discussed below. These determinations will be made following the
issuance of the report to manufacturers, but as we are not finalizing
the date we will issue the first report, we cannot finalize timing for
determinations of nonpayment. Finally, this determination can be
performed remotely.
Commenter: One commenter suggested we conduct post-claims reviews
for providers with unusual JW and JZ modifier reporting patterns. One
commenter, while generally supporting our proposal for provider audits,
requested a process for those audits that allows manufacturers to guide
audit efforts by suggesting particular issues or trends that warrant
attention. One commenter supported our proposal to not significantly
increase the volume of post-payment claims reviews to identify claims
submitted without the JW or JZ modifiers.
Response: We agree with the commenter that provider audits should
focus on unusual JW and JZ modifier reporting patterns. We also agree
that engagement with manufacturers on potential issue areas in discard
reporting practices can make the provider audit process more targeted
and effective. In response to the comment about audits specifically for
identifying claims without the JW or JZ modifiers, we are finalizing
that we will continue the JW reporting requirement and that the JZ
modifier will be required for dates of service beginning July 1, 2023.
In addition, we will begin editing for the use of both the JW and JZ
modifiers beginning October 1, 2023.
Comment: One commenter stated that CMS's actions following adverse
manufacturer audit findings should start with an opportunity for
education and correction prior to any enforcement action or penalties.
Response: We disagree with the commenter. We proposed to impose
civil money penalties only on manufacturers who fail to remit refunds
to CMS in a timely manner. We clarify our proposal on the amount of
time manufacturers have to pay a refund if, after the resolution of a
dispute, we find that the provider owes a refund. Although in one part
of the proposed rule we stated that manufacturers have until 30 days
following the resolution of the dispute to pay the refund, in another
part of the proposed rule we stated refunds would be due December 31 of
the year in which a report is issued to manufacturers even if the
amount is under dispute. We are finalizing the former, as discussed
above in section III.A.7 of this final rule. We continue to believe
this is ample time for manufacturers to comply with a report for refund
obligations.
Comment: One commenter stated that the imposition of civil money
penalties should not be set before a manufacturer has had the
opportunity to meaningfully engage CMS in a dispute process.
Response: We agree with the commenter that civil money penalties
should not be imposed while the window for disputing a refund amount is
still open, when the dispute process is ongoing, and not before a
reasonable amount of time has passed since either the report was first
sent to the manufacturer or the dispute process concluded with a
decision finding that the manufacturer has a refund obligation.
After consideration of the public comments, we are finalizing the
regulations of Sec. 414.490(e) that at this time, manufacturer audits
will be limited to determinations that they have paid refund
obligations or not and will revisit timing of those determinations in
future rulemaking. We are also finalizing that provider audits of Part
B medication claims will be conducted periodically to determine whether
the JW modifier, JZ modifier, and discarded drug amounts are billed
appropriately consistent with our normal claims audit policies and
protocols. Finally, we are
[[Page 69734]]
finalizing that we will impose a penalty of 125 percent of the fund
amount owed if the manufacturer fails to remit refund obligations.
Comment: We received public comments that were outside the scope of
the discarded amount refund proposals included in the CY 2023 PFS
proposed rule. These comments were related to: guidance to FDA on
encouraging or requiring manufacturers to use more efficient drug
packaging, the impacts of the policy on drug and biological research
and development and market participation, the review burden imposed on
FDA by the refund policy, the Medicare program's use of the refund
revenues, the impact of the refunds for Medicare beneficiaries, and
comparative billing reports to providers focusing on JW modifier
reporting.
Response: We consider these public comments to be outside the scope
of the proposed rule, and therefore, we are not addressing them in this
final rule. We may consider these public comments for possible
proposals in future rulemaking.
B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
As provided in 42 CFR part 405, subpart X of our regulations, RHC
and FQHC visits generally are defined as face-to-face encounters
between a patient and one or more RHC or FQHC practitioners during
which one or more RHC or FQHC qualifying services are furnished. RHC
and FQHC practitioners are physicians, NPs, PAs, CNMs, clinical
psychologists (CPs), and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient in an area with a shortage of
home health agencies. Transitional Care Management (TCM) services can
also be paid by Medicare as an RHC or FQHC visit. In addition, Diabetes
Self-Management Training (DSMT) or Medical Nutrition Therapy (MNT)
sessions furnished by a certified DSMT or MNT program may also be
considered FQHC visits for Medicare payment purposes. Only medically
necessary medical, mental health, or qualified preventive health
services that require the skill level of an RHC or FQHC practitioner
are RHC or FQHC billable visits. Services furnished by auxiliary
personnel (for example, nurses, medical assistants, or other clinical
personnel acting under the supervision of the RHC or FQHC practitioner)
are considered incident to the visit and are included in the per-visit
payment.
RHCs generally are paid an all-inclusive rate (AIR) for all
medically necessary medical and mental health services and qualified
preventive health services furnished on the same day (with some
exceptions). The AIR is subject to a payment limit, meaning that an RHC
will not receive any payment beyond the specified limit amount. As of
April 1, 2021, all RHCs are subject to new payment limits on the AIR,
and this limit will be determined for each RHC in accordance with
section 1833(f) of the Act.
FQHCs were paid under the same AIR methodology until October 1,
2014. Beginning that date, in accordance with section 1834(o) of the
Act (as added by section 10501(i)(3) of the Affordable Care Act), they
began to transition to the FQHC PPS system, in which they are paid
based on the lesser of the FQHC PPS rate or their actual charges. The
FQHC PPS rate is adjusted for geographic differences in the cost of
services by the FQHC PPS geographic adjustment factor (GAF). The rate
is increased by 34 percent when an FQHC furnishes care to a patient
that is new to the FQHC, or to a beneficiary receiving an initial
preventive physical examination (IPPE) or has an annual wellness visit
(AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted for
the complexity of the patient health care needs, the length of the
visit, or the number or type of practitioners involved in the patient's
care.
b. Care Management Services in RHCs and FQHCs
We have been engaged in a multi-year examination of coordinated and
collaborative care services in professional settings, and as a result
established codes and separate payment in the PFS to separately
recognize and pay for these important services. The care coordination
included in services, such as office visits, do not always adequately
describe the non-face-to-face care management work involved in primary
care. Payment for office visits may not reflect all the services and
resources required to furnish comprehensive, coordinated care
management for certain categories of beneficiaries, such as those who
are returning to a community setting following discharge from a
hospital or skilled nursing facility (SNF) stay.
A separate payment was established in the CY 2016 PFS final rule
with comment period (80 FR 71080 through 71088) for RHCs and FQHCs that
furnish Chronic Care Management (CCM) services. We believe the non-
face-to-face time required to coordinate care is not captured in the
RHC AIR or the FQHC PPS payment, particularly for the rural and/or low-
income populations served by RHCs and FQHCs. Allowing separate payment
for CCM services in RHCs and FQHCs is intended to reflect the
additional resources necessary for the unique components of CCM
services.
In the CY 2018 PFS final rule with comment period (82 FR 53169 and
53180), we finalized revisions to the payment methodology for CCM
services furnished by RHCs and FQHCs and established requirements for
general Behavioral Health Integration (BHI) and psychiatric
Collaborative Care Management (CoCM) services furnished in RHCs and
FQHCs, beginning on January 1, 2018. We also initiated the use of HCPCS
code G0511, a General Care Management code for use by RHCs or FQHCs
when at least 20 minutes of qualified CCM or general BHI services are
furnished to a patient in a calendar month. In the CY 2019 PFS final
rule (83 FR 59683), we explained for CY 2018 the payment amount for
HCPCS code G0511 was set at the average of the 3 national non-facility
PFS payment rates for the CCM and general BHI codes and updated
annually based on the PFS amounts. That is, for CY 2018 the 3 codes
that comprised G0511 were CPT code 99490 (20 minutes or more of CCM
services), CPT code 99487 (60 minutes or more of complex CCM services),
and CPT code 99484 (20 minutes or more of BHI services).
We also explained that another CCM code was introduced for
practitioners billing under the PFS, CPT code 99491, which would
correspond to 30 minutes or more of CCM furnished by a physician or
other qualified health care professional and is similar to CPT codes
99490 and 99487 (83 FR 56983). Therefore, for RHCs and FQHCs, we added
CPT code 99491 as a general care management service and included it in
the calculation of HCPCS code G0511. Starting on January 1, 2019, RHCs
and FQHCs were paid for HCPCS code G0511 based on the average of the
national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, and 99491 (83 FR 59687).
In the CY 2020 PFS final rule with comment (84 FR 62692), we
established a separate payment for Principle Care Management (PCM)
services under the PFS. PCM services include
[[Page 69735]]
comprehensive care services for a single high-risk disease or complex
condition, typically expected to last at least 3 months and may have
led to a recent hospitalization, and/or placed the patient at
significant risk of death. Beginning January 1, 2020, practitioners
billing under the PFS can bill for PCM services using HCPCS codes G2064
or G2065. HCPCS code G2064 is for at least 30 minutes of PCM services
furnished by physicians or nonphysicians during a calendar month. HCPCS
code G2065 is for at least 30 minutes of PCM services furnished by
clinical staff under the direct supervision of a physician or non-
physician during a calendar month.
In the CY 2021 PFS final rule (85 FR 84697 through 84699), we
explained that since the requirements for the new PCM codes were
similar to the requirements for the services described by HCPCS code
G0511, we added HCPCS code G2064 and G2065 to G0511 as a general care
management service for RHCs and FQHCs starting January 1, 2021. The
payment rate for HCPCS G0511 for CY 2021 was the average of the
national non-facility PFS payment rate for the RHC and FQHC care
management and general behavioral health codes (CPT codes 99490, 99487,
99484, and 99491), and PCM codes (HCPCS G2064 and G2065). Finally, we
note that in the CY 2022 PFS final rule (86 FR 65118), HCPCS codes
G2064 and G2065 were replaced by CPT codes 99424 and 99435. Therefore,
for CY 2022 the current payment rate for HCPCS G0511 is the average of
the national non-facility PFS payment rate for the RHC and FQHC care
management and general behavioral health codes (CPT codes 99490, 99487,
99484, and 99491), and PCM codes (CPT codes 99424 and 99425).
Additional information on care management requirements is available
on the CMS Care Management web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html
and on the CMS RHC and FQHC web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
2. New Care Management Codes for Chronic Pain Management (CPM) and
General Behavioral Health Integration (GBHI)
As discussed in the CY 2023 PFS proposed rule (87 FR 46064 through
46065), under the PFS we proposed two new HCPCS codes to describe CPM
and the proposed CPM codes would be created to separately pay for a
specified set of pain management and treatment services, specifically
including the administration of validated rating scales, and a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes.
(1) HCPCS codes G3002: Chronic pain management and treatment,
monthly bundle including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and maintenance of a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes; overall treatment management; facilitation and
coordination of any necessary behavioral health treatment; medication
management; pain and health literacy counseling; any necessary chronic
pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.
physical therapy and occupational therapy, and community-based care, as
appropriate. Required initial face-to-face visit at least 30 minutes
provided by a physician or other qualified health professional; first
30 minutes personally provided by physician or other qualified health
care professional, per calendar month. (When using G3002, 30 minutes
must be met or exceeded.)
(2) HCPCS code G3003: Each additional 15 minutes of chronic pain
management and treatment by a physician or other qualified health care
professional, per calendar month. For G3002, CPM services, we are
requiring a face-to-face visit of at least 30 minutes provided by a
physician or other qualified health professional, per calendar month to
a beneficiary who has a diagnosis of pain that has lasted more than 3
months, which could be the result of an underlying medical disease or
condition. HCPCS code G3003 will apply to up to three units of an
additional 15 minutes of CPM and treatment by a physician or other
qualified health care professional, per calendar month (listed
separately in addition to HCPCS code G3002). The new codes for CPM
would be valued using crosswalks to the CY 2023 PCM services, CPT codes
99424 and 99425.
We also discussed proposed new coding and payment under the PFS for
general BHI services. That is, the new HCPCS code (G0323): (Care
management services for behavioral health conditions, at least 20
minutes of clinical psychologist or clinical social worker time, per
calendar month, with the following required elements: initial
assessment or follow-up monitoring, including the use of applicable
validated rating scales; behavioral health care planning in relation to
behavioral/psychiatric health problems, including revision for patients
who are not progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination with an/or
referral to physicians and practitioners who are authorized by Medicare
law to prescribe medications and furnish E/M services counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team) describing general BHI services performed by
clinical psychologists (CPs) and clinical social workers (CSWs). As
proposed, the payment rate for the new General BHI code would be based
on the payment rate for the current general BHI code, 99484. We noted
that CPs and CSWs are statutorily authorized to furnish services in
RHCs and FQHCs, as described by Sec. 405.2411(a)(6).
We explained the requirements for the CPM service (that is, HCPCS
code G3002) would be similar to the requirements for the general care
management services furnished by RHCs and FQHCs and as such, we believe
the non-face-to-face time required to coordinate care is not captured
in the RHC AIR or the FQHC PPS payment, particularly for the rural and/
or underserved populations served by RHCs and FQHCs. The pain
management coordination included in services, such as office visits, do
not always adequately describe the non-face-to-face pain management
services involved in primary care.
Allowing separate payment for CPM services in RHCs and FQHCs is
intended to reflect the additional time and resources necessary for the
unique components of care coordination services. We did not propose to
utilize the add-on HCPCS code G3003 for RHC/FQHC payments because RHCs
and FQHCs do not pay their practitioners based on additional minutes
spent by practitioners, as is the case for practitioners under the PFS.
In an effort to be consistent with the new services that were proposed
for practitioners billing under the PFS, we proposed to include CPM
services in the general care management HCPCS code G0511 when these
services are provided by RHCs and FQHCs. Since HCPCS code G3002 would
be valued using a crosswalk to the PCM CPT code 99424, which is
currently one of the CPT codes that comprise HCPCS code G0511, we did
not propose a change to the average used to calculate the HCPCS code
G0511 payment rate.
In addition, as explained in the proposed rule, since CPs and CSWs
are
[[Page 69736]]
statutorily authorized to furnish services in RHCs/FQHCs, we clarified
that when CPs and CSWs furnish the services described in HCPCS code
G0323 in an RHC or FQHC, they can bill HCPCS code G0511.
We noted that if finalized as proposed, RHCs and FQHCs that furnish
the new CPM and GBHI services furnished by CPs and CSWs would be able
to bill these services using HCPCS code G0511, either alone or with
other payable services on an RHC or FQHC claim for dates of service on
or after January 1, 2023. The payment rate for HCPCS code G0511 would
continue to be the average of the national non-facility PFS payment
rates for the RHC and FQHC care management and general behavioral
health codes (CPT codes 99484, 99487, 99490, and 99491) and PCM codes
(CPT codes 99424 and 99425) and would be updated annually based on the
PFS amounts for these codes.
We also noted that we may consider other approaches in future
rulemaking for calculating the rate of HCPCS code G0511 as the number
of services is growing each year. For example, we could value HCPCS
code G0511 using a weighted average of the services that comprise HCPCS
code G0511 or using the national average of the top three services
comprising HCPCS code G0511. We welcomed comments on potential
methodologies.
Finally, we note that the codes GYYY1, GYYY2, and GBHI1 in the
proposed rule were placeholder codes and that the final code numbers
will be HCPCS code G3002, G3003, and G0323 respectively and
corresponding discussions have been updated.
The following is a summary of the public comments received on the
new care management codes for Chronic Pain Management (CPM) and General
Behavioral Health Integration (GBHI) and our responses:
Comment: The majority of the commenters supported our proposal to
allow RHCs and FQHCs to furnish CPM services; however, they would like
CMS to treat HCPCS code G3002 as an encounter and reimburse these
services at the RHC AIR or at the FQHC PPS rate, instead of bundling
the services under the general care management code, HCPCS code G0511.
The commenters noted that the definition of an RHC or FQHC encounter is
a face-to-face encounter between a patient and an RHC or FQHC
practitioner during which a qualified service is furnished. They
explained that the proposed codes require a face-to-face visit for at
least 30 minutes with a RHC or FQHC practitioner, therefore clearly
meeting the definition of an RHC or FQHC encounter.
Response: We appreciate the feedback from commenters regarding the
addition of CPM services and the proposed reimbursement for these
services. We agree that the description of HCPCS code G3002 includes a
face-to-face component. As explained in the CY 2023 PFS proposed rule
(87 FR 45936 through 45937), to value CPM, we compared the proposed
services to codes that involve care management. In doing so, we
concluded that the CPM services were similar in work (time and
intensity) to that of PCM in that both the PCM codes and proposed CPM
codes reflected services that have similar complexities, possible
comorbidities, require cognitive time on the part of the practitioner,
and may involve coordination of care across multiple practitioners.
Therefore, in an effort to pay the same for similar services, and for
RHCs and FQHCs we pay PCM using HCPCS code G0511, we did not believe it
is appropriate to pay CPM as a visit.
After consideration of public comments, we have reconsidered our
approach to billing CPM services. Many Medicare beneficiaries have
multiple chronic conditions, and many of these conditions could involve
chronic pain. We believe it is reasonable to assume that in many
instances, the RHC or FQHC practitioner could be spending time with the
Medicare patient discussing health and wellness related to a variety of
conditions that a person may be experiencing, or expect to experience,
and that interaction might also have a focus on the chronic pain
aspects of the person's care. Addressing chronic pain as part of a
visit would complete the face-to-face component of CPM. Billing of
HCPCS code G0511 would address the non-face-to-face components of CPM.
Therefore, both the face-to-face visit and the non-face-to-face
components of CPM as an add-on service(s) could be on the same day if
all requirements to report each service are met, without time or effort
being counted more than once. We believe having the ability to bill
both a face-to-face visit and a non-face-to-face CPM add-on service on
the same day mitigates concerns from the commenters since payment for
the RHC or FQHC visit accounts for the face-to-face component and
payment for non-face-to-face CPM services accounts for the additional
time and resources necessary for the unique components of care
coordination for non-face-to-face CPM services furnished outside of the
face-to-face visit with an RHC or FQHC practitioner. Therefore, we are
finalizing as proposed to include non-face-to-face CPM services
described in HCPCS code G3002 in the general care management HCPCS code
G0511 when these services are furnished by RHCs and FQHCs.
Comment: A few commenters encouraged CMS to permit RHCs and FQHCs
to provide CCM and GBHI to a patient in the same calendar month and
receive the separate reimbursement for each service.
Response: We note that we did not specifically make any proposals
in the CY 2023 PFS proposed rule to simultaneously bill CCM or BHI
service in the same calendar month. In the CY 2021 PFS final rule with
comment (86 FR 84699), we finalized a policy that general care
management services furnished in RHCs and FQHCs can only be billed once
per month per beneficiary when at least 20 minutes of CCM services, at
least 30 minutes of PCM services, or at least 20 minutes of general BHI
services have been furnished and all requirements have been met.
Therefore, if the requirements for each of these care management
services are met, then HCPCS code G0511 can be billed more than once in
a calendar month, either alone or with other payable services and the
same would apply for CPM and GBHI.
Comment: One commenter recommended CMS to further designate if
separately reportable procedures are able to be billed during the
proposed 30-day CPM management period, and if CMS allows for separately
reportable procedures (for example, injections, dry needling,
acupuncture, PT/OT) to be performed during the same billing period,
then CMS should define any limitations on which ones are, or are not,
separately billable.
Response: We appreciate the commenter's feedback. Procedures, such
as injections, dry needling, acupuncture, and PT/OT, may be furnished
by auxiliary personnel ``incident to'' an encounter with an RHC or FQHC
practitioner in a medically appropriate timeframe, as described by
Sec. Sec. 405.2413 and 405.2415. More than one ``incident to'' service
or supply can be provided as a result of a single encounter with an RHC
or FQHC practitioner. However, they cannot be separately billed as
separate visits.
Comment: One commenter requested that CMS allow RHCs and FQHCs to
bill for the new HCPCS code G3003 which applies up to three units of an
additional 15 minutes of CPM per month.
Response: We appreciate the feedback from the commenter regarding
the new CPM HCPCS code that describes the additional time spent by
practitioners. We did not propose to utilize the add-
[[Page 69737]]
on HCPCS code G3003 for RHC/FQHC payments because RHCs and FQHCs do not
pay their practitioners based on additional minutes spent by
practitioners, as is the case for practitioners paid under the PFS. As
we stated in the CY 2016 PFS final rule (80 FR 71086) when we added
CCM, we explained that additional minutes as follows: the service
period for billing CCM services in RHCs and FQHCs is one calendar
month, and we expect the RHC or FQHC to continue furnishing services
during a given month as applicable even after the 20-minute time
threshold to bill the service is met. The RHC or FQHC could bill for
the CCM service after completion of at least 20 minutes of qualifying
CCM services during the service period, or any time after that until
the end of the month. This is consistent for other care management
services included in HCPCS code G0511 and now extends to CPM services.
RHCs and FQHCs must meet the minimum of 30 minutes in order to bill
HCPCS code G0511 for CPM services.
Comment: Generally, commenters were supportive of the clarification
that when CPs and CSWs provide the services described in HCPCS code
G0323 in an RHC or FQHC, they can bill HCPCS code G0511 as statutorily
authorized RHC and FQHC practitioners.
Response: We appreciate the support received from commenters.
Comment: Commenters urged CMS to create billing codes that reflect
the complexities between RHC and FQHC patients and provide variable
reimbursement rates that reflect the varying levels of care management
services provided. Commenters opined that adding CPM and GBHI services
further dilutes the reimbursement to RHCs and FQHCs under HCPCS code
G0511 drawing attention to the fact that not every patient is the same
as the level of providers needed to treat the patient and time spent
may vary.
Response: We appreciate the feedback in response to our comment
solicitation on potential methodologies for calculating the rate of
HCPCS code G0511 and will take this information into consideration for
future rulemaking.
After consideration of the public comments, and in an effort to be
consistent with the new services finalized in section II.E of this
final rule for practitioners billing under the PFS, we are finalizing
as proposed to include CPM services described by HCPCS code G3002 in
the general care management HCPCS code G0511 when these services are
furnished by RHCs and FQHCs. Since HCPCS code G3002 is valued using a
crosswalk to the PCM CPT code 99424, which is currently one of the CPT
codes that comprise HCPCS code G0511, there is no change to the average
used to calculate the HCPCS code G0511 payment rate to reflect CPM
services. This is in addition to the face-to-face visit component of
CPM services. We note as discussed in section II.E of this final rule,
we are finalizing the descriptor of HCPCS code G3002 as follows, with
the two modifications shown in italics: Chronic pain management and
treatment, monthly bundle including, diagnosis; assessment and
monitoring; administration of a validated pain rating scale or tool;
the development, implementation, revision, and/or maintenance of a
person-centered care plan that includes strengths, goals, clinical
needs, and desired outcomes; overall treatment management; facilitation
and coordination of any necessary behavioral health treatment;
medication management; pain and health literacy counseling; any
necessary chronic pain related crisis care; and ongoing communication
and care coordination between relevant practitioners furnishing care,
for example, physical therapy and occupational therapy, complementary
and integrative approaches, and community-based care, as appropriate.
Required initial face-to-face visit at least 30 minutes provided by a
physician or other qualified health professional; first 30 minutes
personally provided by physician or other qualified health care
professional, per calendar month. (When using HCPCS code G3002, 30
minutes must be met or exceeded.)
In addition, CPs and CSWs are statutorily authorized to furnish
services in RHCs and FQHCs, and therefore, we are finalizing the
clarification that when CPs and CSWs provide the services described in
HCPCS code G0323 in an RHC or FQHC, they can bill HCPCS code G0511.
RHCs and FQHCs that furnish CPM and GBHI services are able to bill
these services using HCPCS code G0511, either alone or with other
payable services on an RHC or FQHC claim for dates of service on or
after January 1, 2023. The payment rate for HCPCS code G0511 will
continue to be the average of the national non-facility PFS payment
rates for the RHC and FQHC care management and general behavioral
health codes (CPT codes 99484, 99487, 99490, and 99491) and PCM codes
(CPT codes 99424 and 99425) and will be updated annually based on the
PFS amounts for these codes. In addition, we will take into
consideration the comments we received in response to our comment
solicitation on potential methodologies for calculating the rate of
HCPCS code G0511 for future rulemaking.
3. Conforming Technical Changes to 42 CFR 405.2463 and 405.2469
Last year in the CY 2022 PFS final rule with comment (86 FR 65211),
we revised the regulatory requirement that an RHC or FQHC mental health
visit must be a face-to-face (that is, in person) encounter between an
RHC or FQHC patient and an RHC or FQHC practitioner. We revised the
regulations under Sec. 405.2463 to state that an RHC or FQHC mental
health visit can also include encounters furnished through interactive,
real-time, audio and video telecommunications technology or audio-only
interactions in cases where beneficiaries are not capable of, or do not
consent to, the use of devices that permit a two-way, audio/video
interaction for the purposes of diagnosis, evaluation or treatment of a
mental health disorder. We noted that these changes aligned with
similar mental health services furnished under the PFS. We also noted
that this change allows RHCs and FQHCs to report and be paid for mental
health visits furnished via real-time, telecommunication technology in
the same way they currently do when these services are furnished in-
person.
In addition, we revised the regulation under Sec. 405.2463 to
state that there must be an in-person mental health service furnished
within 6 months prior to the furnishing of the telecommunications
service and that an in-person mental health service (without the use of
telecommunications technology) must be provided at least every 12
months while the beneficiary is receiving services furnished via
telecommunications technology for diagnosis, evaluation, or treatment
of mental health disorders, unless, for a particular 12-month period,
the physician or practitioner and patient agree that the risks and
burdens outweigh the benefits associated with furnishing the in-person
item or service, and the practitioner documents the reasons for this
decision in the patient's medical record (86 FR 65210 and 65211).
We also revised the regulation under Sec. 405.2469, FQHC
supplemental payments, to state that a supplemental payment required
under this section is made to the FQHC when a covered face-to-face
(that is, in-person) encounter or an encounter where services are
furnished using interactive, real-time, telecommunications technology
or
[[Page 69738]]
audio-only interactions in cases where beneficiaries do not wish to use
or do not have access to devices that permit a two-way, audio/video
interaction for the purposes of diagnosis, evaluation or treatment of a
mental health disorder occurs between a MA enrollee and a practitioner
as set forth in Sec. 405.2463. At Sec. 405.2469, we also revised
paragraph (d) to describe the same in-person visit requirement
referenced in Sec. 405.2463.
As discussed in the CY 2023 PFS proposed rule (87 FR 46065), the
Consolidated Appropriations Act, 2022 (Pub. L. 117-103) (CAA, 2022)
signed into law on March 15, 2022, included the extension of a number
of Medicare telehealth flexibilities established during the PHE for a
limited 151-day period beginning on the first day after the end of the
public health emergency (PHE) for COVID-19. Specifically, section 303
of the CAA, 2022 amended section 1834(m)(8) of the Act to extend
payment for telehealth services furnished by FQHCs and RHCs for the
151-day period beginning on the first day after the end of the COVID-19
PHE. We explained that payment would continue to be made under the
methodology established for telehealth services furnished by FQHCs and
RHCs during the PHE, which is based on payment rates that are similar
to the national average payment rates for comparable telehealth
services under the PFS. We noted that we did not believe it was
necessary to conform the regulation for this temporary provision.
We also discussed section 304 of the CAA, 2022 which delayed the
in-person requirements under Medicare for mental health services
furnished through telehealth under the PFS and for mental health visits
furnished by RHCs and FQHCs via telecommunications technology. We noted
this change required conforming regulatory text. For RHCs and FQHCs,
in-person visits will not be required until the 152nd day after the end
of the PHE for COVID-19. We noted that while the extensions of mental
health telehealth visits under section 304 of the CAA, 2022 were placed
into paragraphs of section 1834 of the Act applicable only to hospice
patients served by RHCs and FQHCs, the overall intent of the amendments
made by section 304 of the CAA, 2022 appear to be to provide an
exception to the limitations otherwise in place on payment for mental
health visits that are not in-person visits. Therefore, we proposed to
apply the 151-day extension of non-in-person visits to all RHC and FQHC
mental health visits.
We proposed to make conforming regulatory text changes to the
applicable RHC and FQHC regulations in 42 CFR part 405, subpart X,
specifically, at Sec. 405.2463, ``What constitutes a visit,'' we
proposed to amend paragraph (b)(3) and, at Sec. 405.2469 ``FQHC
supplemental payments,'' we proposed to amend paragraph (d) to include
the delay of the in-person requirements for mental health visits
furnished by RHCs and FQHCs through telecommunication technology under
Medicare until the 152nd day after the PHE for COVID-19.
In the CY 2023 PFS proposed rule we listed the several other
provisions of the CAA, 2022 that apply to telehealth services (those
that are not mental health visits) furnished by RHCs and FQHCs. These
provisions are also listed in the following paragraphs.
Section 301 of the CAA, 2022 amended section 1834(m)(4)(C) of the
Act to add a new clause (iii) expand the originating site requirements
to include any site in the U.S. at which the beneficiary is located,
including an individual's home, for a 151-day period beginning on the
first day after the end of the PHE for COVID-19. It also prohibits an
originating site facility fee from being paid unless the site is a
setting included on the originating site list in section
1834(m)(4)(C)(ii) of the Act, excluding the home of an individual.
Section 305 of division P, title III, subtitle A of the CAA, 2022
amended section 1834(m) of the Act to extend coverage and payment of
telehealth services that are furnished via audio-only
telecommunications system for the 151-day period beginning on the first
day after the end of the PHE for COVID-19.
Section 309 of division P, title III, subtitle A of the CAA, 2022
authorized the Secretary to implement the Medicare telehealth
provisions via program instruction or otherwise.
The following is a summary of the public comments received on the
conforming technical changes to Sec. Sec. 405.2463 and 405.2469 our
responses:
Comment: All commenters supported our proposal to make conforming
regulatory text changes to the applicable RHC and FQHC regulations in
42 CFR part 405, subpart X, specifically, at Sec. 405.2463, ``What
constitutes a visit,'' and at Sec. 405.2469 ``FQHC supplemental
payments'' to reflect the delay of the in-person requirements for
mental health visits furnished by RHCs and FQHCs through
telecommunication technology under Medicare until the 152nd day after
the PHE for COVID-19. One commenter stated the delay of the in-person
requirements would ensure consumers and caregivers have time to plan
how they will attend an in-person visit, including arranging for
childcare or transportation, and meeting other logistical challenges.
Several commenters expressed concern that the in-person requirements
would pose a challenge for some beneficiaries due to various social
determinants of health and would like CMS to permanently remove the in-
person requirements.
Response: We appreciate the feedback from commenters regarding the
impact in-person requirements for mental health visits furnished by
RHCs and FQHCs through telecommunication technology may have on access
to care. Regarding concerns that the in-person requirements would pose
a challenge for some beneficiaries due to various social determinants
of health, we would like to direct you to Sec. 405.2463(b)(3) that
describes the exceptions to the in-person visit requirements. An in-
person mental health service (without the use of telecommunications
technology) must be provided at least every 12 months while the
beneficiary is receiving services furnished via telecommunications
technology for diagnosis, evaluation, or treatment of mental health
disorders, unless, for a particular 12-month period, the physician or
practitioner and patient agree that the risks and burdens outweigh the
benefits associated with furnishing the in-person item or service, and
the practitioner documents the reasons for this decision in the
patient's medical record, between an RHC or FQHC patient.
Comment: Commenters supported the Medicare telehealth extensions,
but urged CMS to permanently allow RHCs and FQHCs to become distant
sites for medical visits furnished using interactive, real-time, audio
and video telecommunications, or audio-only interactions. Several
commenters noted CMS has the authority to revise the definition of a
medical visit for RHCs and FQHCs and should do so prior to the end of
the COVID-19 PHE to avoid consequential gaps in care for some of the
most vulnerable Medicare patients.
Response: In response to comments that CMS permanently allow RHCs
and FQHCs to become distant sites for medical visits, we note that the
use of telecommunications technology by RHCs and FQHCs to furnish
medical visits was not within the scope of this proposal. However, we
anticipate that the extension of payment for distant site telehealth
services furnished by RHCs and FQHCs for a 151-day period after the end
of the PHE, as established in the CAA, 2022, would mitigate concerns
regarding gaps in care since it could
[[Page 69739]]
provide time for transitioning patients to come into the RHC or FQHC.
Comment: Commenters also provided comments on the following issues:
Allowing RHCs and FQHCs to bill separately for remote physiologic
monitoring (RPM) and remote therapeutic monitoring (RTM) services;
recognizing pharmacists, DSMT providers, licensed professional
counselors (LPCs) and licensed marriage and family therapist (LMFTs) as
RHC and FQHC practitioners; and allowing RHCs and FQHCs to bill
psychiatric collaborative care codes (G2214, 99492-99494).
Response: We appreciate the feedback from commenters. Since we did
not specifically make any proposals associated with these subjects in
the CY 2023 PFS proposed rule, the comments are considered to be out of
scope. We note that while we recognize that pharmacists, DSMT
providers, LPCs, and LMFTs can be a valuable part of the health care
team, we do not have the statutory authority to add providers to the
list of RHC and FQHC practitioners whose services are included in the
statutory definition of RHC and FQHC services, as specified in section
1861(aa)(1) and (3) of the Act, respectively. However, incidental
services furnished by auxiliary personnel are allowed incident to an
encounter with and RHC or FQHC practitioner if furnished in a medically
appropriate timeframe, as described by 42 CFR 405.2413 and 405.2415. As
for allowing RHCs and FQHCs to bill RPM and RTM services separately and
allowing RHCs and FQHCs to bill psychiatric collaborative care codes,
we will continue to evaluate and may consider these in future
rulemaking.
After consideration of the comments received, we are finalizing our
proposal to make conforming regulatory text changes to the applicable
RHC and FQHC regulations in 42 CFR part 405, subpart X. Specifically,
we are finalizing revisions at Sec. Sec. 405.2463 and 405.2469 to
reflect the delay of the in-person requirements for mental health
visits furnished by RHCs and FQHCs through telecommunication technology
under Medicare until the 152nd day after the PHE for COVID-19 as
proposed.
4. Specified Provider-Based RHC Payment-Limit Per-Visit
a. Background
As discussed in the CY 2023 PFS proposed rule (87 FR 46065 through
46066), beginning April 1, 2021, provider-based RHCs that meet
qualifications in section 1833(f)(3)(B) of the Act are entitled to the
special payment rules described in section 1833(f)(3)(A) of the Act. In
order avail themselves of this exception, instead of utilizing the
national statutory payment limit set out at section 1833(f)(2) of the
Act, such RHCs have to meet the following specified criteria set out at
section 1833(f)(3)(B)(i) of the Act:
As of December 31, 2020, the provider-based RHC was in a
hospital with less than 50 beds and after December 31, 2020 in a
hospital that continues to have less than 50 beds (not taking into
account any increase in the number of beds pursuant to a waiver during
the PHE for COVID-19); and one of the following circumstances:
++ As of December 31, 2020, was enrolled in Medicare (including
temporary enrollment during the PHE for COVID-19); or
++ Submitted an application for enrollment in Medicare (or a
request for temporary enrollment during the PHE for COVID-19) that was
received not later than December 31, 2020.
In accordance with section 1833(f)(3)(A)(i)(I) of the Act,
beginning April 1, 2021, for provider-based RHCs that had a per visit
payment amount (or AIR) established for services furnished in 2020, the
payment limit per visit shall be set at an amount equal to the greater
of: (1) the per visit payment amount applicable to such RHC for
services furnished in 2020, increased by the percentage increase in the
MEI applicable to primary care services furnished as of the first day
of 2021; or (2) the national statutory payment limit for RHCs per
visit. We noted, the MEI was last revised in the CY 2014 PFS final rule
with comment period (78 FR 74264) and we are finalizing to rebase and
revise the MEI for CY 2023 as detailed in section II.M of this final
rule.
In a subsequent year (that is, after 2021), the provider-based
RHC's payment limit per visit shall be set at an amount equal to the
greater of: (1) the payment limit per visit established for the
previous year, increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first day of
such subsequent year; or (2) the national statutory payment limit for
RHCs.
As stated in the CY2022 PFS final rule (86 FR 65200), in accordance
with section 1833(f)(3)(A)(i)(II) of the Act, beginning April 1, 2021,
for provider-based RHCs that met the specified criteria under section
1833(f)(3)(B) of the Act, but did not have a per visit payment amount
(or AIR) established for services furnished in 2020, the payment limit
per visit would be set at an amount equal to the greater of: (1) the
per visit payment amount applicable to the provider-based RHC for
services furnished in 2021; or (2) the national statutory payment limit
for RHCs.
In a subsequent year (that is, after 2021), the provider-based RHCs
payment limit per visit will be the greater of: (1) the payment limit
per visit established for the previous year, increased by the
percentage increase in MEI applicable to primary care services
furnished as of the first day of such subsequent year; or (2) the
national statutory payment limit for RHCs.
Once a provider-based RHC meets the qualifications of section
1833(f)(3)(B) of the Act, it will lose its designation if the hospital
does not continue to have less than 50 beds, beyond the exemptions
provided for the COVID-19 PHE. If this occurs the provider-based RHC
would be subject to the statutory payment limit per visit applicable
for such year and will not be able to regain the specified provider-
based payment limit.
In the CY 2022 PFS final rule (86 FR 65204), we discussed the
provisions in section 1833(f) of the Act \153\ and finalized conforming
regulations under Sec. 405.2462. On March 16, 2021, we issued Change
Request 12185, Transmittal 10679, to instruct the Medicare
Administrative Contractors (MACs) to establish the provider-based RHC
payment limits per visit in accordance with section 1833(f)(3)(A) of
the Act, beginning April 1, 2021. Change Request 12185, Transmittal
10679, was rescinded and replaced by Transmittal 10780 issued on May 4,
2021.\154\ Change Request 12489, Transmittal 11130, issued on November
19, 2021, implemented the RHC payment limits for CY 2022.\155\
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\153\ As amended by Division CC, section 130 of the Consolidated
Appropriations Act of 2021 (Pub. L. 116-260, December 27, 2020).
Section 2 of H.R. 1868 (Pub. L. 117-7), enacted April 14, 2021,
provided a technical correction to section 1833(f) of the Act. The
amendments made by this technical correction took effect as if
included in the enactment of the Consolidated Appropriations Act of
2021 (Pub. L. 116-260).
\154\ https://www.cms.gov/files/document/r10780OTN.pdf.
\155\ https://www.cms.gov/files/document/r11130cp.pdf.
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b. Clarification to the RHC Payment Limit for Specified Provider-Based
RHCs
As we discussed in the CY 2023 PFS proposed rule (87 FR 46066
through 46068), section 1833(f)(3)(A) of the Act instructed CMS to set
payment limits per visit for specified provider-based RHCs under
certain payment rules. For specified provider-based RHCs that had a per
visit payment amount (that is, an AIR) established for services
furnished in 2020, beginning April 1, 2021,
[[Page 69740]]
section 1833(f)(3)(A)(i)(I) of the Act requires the payment limit per
visit to be set at an amount equal to the greater of: (1) the per visit
payment amount applicable to such RHC for services furnished in 2020,
increased by the percentage increase in the MEI applicable to primary
care services furnished as of the first day of 2021 or; (2) the
statutory payment limit per visit as described in section 1833(f)(2)(A)
of the Act. For subsequent years, in accordance with section
1833(f)(3)(A)(ii) of the Act, the payment limit per visit shall be set
at an amount equal to the greater of: (1) the payment limit per visit
established for the previous year, increased by the percentage increase
in the MEI or; (2) the statutory payment limit described in section
1833(f)(2) of the Act as applicable.
For specified provider-based RHCs that did not have an AIR
established for services furnished in 2020, beginning April 1, 2021,
section 1833(f)(3)(A)(i)(II) of the Act requires the payment limit per
visit shall be set at an amount equal to the greater of: (1) the per
visit payment amount applicable to such RHC for services furnished in
2021 or; (2) the statutory payment limit per visit as described in
section 1833(f)(2)(A) of the Act. For subsequent years, in accordance
with section 1833(f)(3)(A)(ii) of the Act, the payment limit per visit
shall be set at an amount equal to the greater of: (1) the amount
established in the previous year increased by the percentage increase
in the MEI or; (2) the statutory payment limit described in section
1833(f)(2) of the Act as applicable.
In the CY 2022 PFS final rule (86 FR 65201), we interpreted the
``per visit payment amount'' to align with the interim rate process the
MACs use in determining an RHC's AIR.\156\ That is, as explained in
Sec. 405.2464(a) the AIR is determined by the MAC using the most
recently available cost report. Therefore, using the RHCs discussed in
section 1833(f)(3)(A)(i)(I) of the Act as an example, we interpreted
the term ``services furnished in 2020'' to mean the period at which the
services were furnished in 2020 and that costs for those services were
reported. We acknowledged that there may be more than one cost report
that reports costs for services furnished in calendar year 2020 and
explained that since section 1833(f)(3)(A)(i)(I)(aa) of the Act
requires the ``per visit payment amount'' to be increased by the CY
2021 MEI, if a provider has a cost reporting period that differs from a
calendar year time-period (that is, January 1, 2020 through December
31, 2020) then the MACs should use data based on the relevant cost
report period ending in 2020.
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\156\ Note: A discussion of the interim rate process is provided
in section III.A.2 of the CY 2022 PFS final rule (86 FR 65198 and
65199).
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We noted that in the CY 2022 PFS final rule (86 FR 65200), we
received comments from interested parties expressing concern about how
the payment limit per visit is established for specified provider-based
RHCs. To be appropriately reflective of an individual clinic's true
costs, one commenter stated that grandfathered, clinic specific, upper
payment limits should be based on the final cost settled amount for
cost reporting periods that end in 2020, or 2021 (for grandfathered
RHCs that did not have cost reporting period that end in 2020), not an
interim rate. If an interim final rate is necessary for the time period
before final cost settled rates are adjudicated, the commenter
suggested that CMS set interim clinic-specific upper limits only until
such time that a final rate is established. In our response to these
comments, we agreed, and stated that what the commenter described was
aligned with the statute and how we implemented the payment limit per
visit for specified provider-based RHCs through Change Request 12185,
Transmittal 10780, issued on May 4, 2021. That is, in accordance with
section 1833(f)(3)(A) of the Act, specified provider-based RHCs that
had a per visit payment amount (or AIR) established for services
furnished in 2020, had their payment limit per visit based on their AIR
determined from their final settled cost report ending in 2020
increased by the percentage increase in the MEI applicable to primary
care services furnished as of the first day of 2021 (CY 2021 MEI of 1.4
percent). However, if the product of those two numbers (AIR established
for services furnished in 2020 * 1.014) were less than the national
statutory payment limit of $100, their payment limit per visit was
established at $100. With regard to a specified provider based RHC that
did not have an AIR established for services furnished in 2020 and
received an interim rate until the MAC accepted and finalized the RHC's
initial cost report, we again agreed with the commenter. We believed
that what the commenter described also aligned with the statute and how
we implemented the payment limit per visit for these specified
provider-based RHCs through Change Request 12185, Transmittal 10780,
issued on May 4, 2021. That is, in accordance with section
1833(f)(3)(A) of the Act, specified provider-based RHCs that did not
have an AIR established for services furnished in 2020, would have
their payment limit per visit established based on their AIR determined
by MACs using the RHC's final settled cost report ending in 2021. The
interim rate estimate would be reconciled at cost report settlement for
the cost reporting period ending in 2021 which is used to establish the
RHC's payment limit per visit for services furnished in 2021.
In the proposed rule, we stated that since publication of the CY
2022 PFS final rule, interested parties requested clarification
regarding the timing of cost reports, specifically if the payment limit
could be set using a short cost report (less than 12 consecutive
months). We noted that in the CY 2022 PFS final rule (86 FR 65198
through 65202), we did not specifically address requiring the cost
report to span a full 12-consecutive month period or whether MACs,
following their interim rate setting process, could establish the
payment limit using a specified RHC's short period cost report (less
than 12 consecutive months). Since many questions were raised
subsequent to the publication of the CY 2022 PFS final rule regarding
the use of short-period cost reports (less than 12 consecutive months)
versus 12-consecutive month cost reports to establish the payment limit
for specified provider-based RHCs, in the proposed rule, we provided a
discussion of the issue and provided clarification.
For purposes of establishing the payment limit effective April 1,
2021 for specified provider-based RHCs defined in section
1833(f)(3)(A)(i)(I) of the Act, that is, had an AIR established for
services furnished in 2020, we proposed that MACs use the cost report
ending in 2020 that reports costs for 12 consecutive months. If the RHC
does not have a 12-consecutive month cost report ending in 2020, the
MACs should use the next most-recent final settled cost report that
reports cost for 12 consecutive months. We explained that the proposal
would impact specified provider-based RHC's that had an established AIR
for services furnished in 2020 but submitted a short cost report (less
than 12 consecutive months) ending in 2020 since that period would have
been used by MACs for determining the RHC's payment limit per Change
Request 12185, Transmittal 10679.
The payment limit per visit is based on each specified provider-
based RHC's AIR determined from their final settled cost report ending
in 2020 when such cost reporting period is for 12 consecutive months.
If a 12-consecutive month cost report ending in 2020 is not available,
we proposed that the MAC
[[Page 69741]]
use the next available 12-consecutive month cost report that reports
costs for RHC services furnished in 2020, (for example, a cost
reporting period October 1, 2020 through September 30, 2021 would be
acceptable).
We considered the idea of combining cost report data that spans
from the end of one year into the next year to equal a 12-consecutive
month cost report (for example, a cost report that consists of 3 months
ending December 31, 2020 plus a cost report that ends July 31, 2021)
and prorating the rates from the time services were furnished in both
years. We decided against combining cost report data to equal a 12-
consecutive month cost report because prorating may result in an
inaccurate AIR. We sought comment on whether we should combine cost
report data that spans from one year into the next year to equal a 12-
consecutive month cost report.
Consequently, for purposes of establishing the payment limit
effective April 1, 2021 for specified provider-based RHCs defined in
section 1833(f)(3)(A)(i)(II) of the Act (that is, those that did not
have an AIR established for services furnished in 2020), we proposed
that MACs use the cost report ending in 2021 that reports costs for 12
consecutive months. We noted that if the RHC does not have a 12-
consecutive month cost report ending in 2021, the MACs should use the
next most-recent final settled cost report that reports cost for 12
consecutive months.
In addition, we noted that for those specified provider-based RHCs
who did not have an AIR established for services furnished in 2020, the
2021 MEI percentage increase would not be applied. As discussed in the
CY 2022 PFS final rule (86 FR 65200), for those specified provider-
based RHCs, the payment limit per visit would be at an amount equal to
the greater of: (1) the per visit payment amount applicable to the
provider-based RHC for services furnished in 2021; or (2) the national
statutory payment limit for RHCs, and since the MEI is already built in
the rate for services furnished in 2021 adding an MEI update would be
duplicative. Therefore, those specified provider-based RHCs that did
not have an AIR established for services furnished in 2020 would
receive the CY 2023 percentage increase in the MEI. For CY 2023, we
proposed to rebase and revise the MEI to a 2017-base year as discussed
in section II.M. of this final rule, we are finalizing the 2017-based
MEI for CY 2023, with technical modifications based on public comments.
We noted that we believe the 12 consecutive months of cost report
data would more accurately reflect the costs of providing RHC services
and would establish a more accurate base from which the payment limits
will be updated going forward. We sought comment on the proposed
interpretation.
The following is a summary of the public comments received on the
specified provider-based RHC payment-limit per-visit provision and our
responses:
Comment: We received a few comments on our proposal to use 12-
consecutive month cost reports versus short-period cost reports (less
than 12 consecutive months) to establish the payment limit for
specified provider-based RHCs. Commenters were generally supportive of
the use of 12 consecutive month cost reports to establish the payment
limit for specified provider-based RHCs.
Response: We appreciate commenters' support of the use of 12
consecutive month cost reports to establish the payment limit for
specified provider-based RHCs.
Comment: We received a few comments on our proposal to rebase and
revise the Medicare Economic Index (MEI) from a 2006-base year to a
2017-base year. One commenter thanked CMS for rebasing and revising the
MEI in such a way that it reflects more accurate payments to RHCs,
however, the commenter urged CMS to explore its authority to ensure
that rural practitioners are reimbursed a rate that reflects the
current economic reality. Another commenter acknowledged and
appreciated CMS' proposal to rebase the MEI for CY2023, but encouraged
CMS to remain attentive to the inflationary impacts on providers now
and over the coming years and to address the MEI formula accordingly.
Another commenter urged CMS to establish a requirement to rebase the
payment every 3 years or sooner as the market inflation costs will
quickly fall below reimbursement rates.
Response: As we noted in the CY 2023 proposed rule (87 FR 46067)
and as discussed in section II.M. of this final rule, the MEI is
authorized under section 1824(b)(3) of the Act. The MEI reflects the
weighted-average annual price change for various inputs involved in
furnishing physicians' services. CMS calculates the MEI for several
statutory and other purposes, which includes the RHC payment policies.
As discussed in section II.M of this final rule, we are finalizing the
2017-based MEI for CY 2023 with technical modifications in response to
public comments. The CY 2023 MEI update is 3.8 percent based on
historical data through the 2nd quarter of 2022, of the finalized 2017-
based MEI.
Comment: One commenter encouraged CMS to consider a more
sustainable payment policy because they noted that over the years the
RHC reimbursement policy has evolved to include a variety of different
methodologies and systems patched together, which has led to
increasingly complicated RHC billing and coding rules.
Response: We reiterate that in this year's proposed rule, we
focused on providing clarification regarding the timing of cost
reports, specifically, the use of short-period cost reports (less than
12 consecutive months) versus 12-consecutive month cost reports to
establish the payment limit for specified provider-based RHCs. We note
that in the CY 2022 final rule (86 FR 65199-65201), we discussed
section 130 of the Consolidated Appropriations Act, 2021, which
explained the implementation of the national statutory payment limit
for RHCs, where RHCs will receive an increase in their payment limit
per visit, over an 8-year period, with a prescribed amount for each
year from 2021-2028. Then, in a subsequent year, at the limit
established for the previous year increased by the percentage increase
in the applicable MEI. We believe the intent of section 130 of the CAA
was to provide sustainable payment for RHCs. The commenter did not
provide examples of complicated billing and coding rules and we look
forward to further engagement on these concerns.
After consideration of the public comments, we are finalizing our
proposal to use 12-consecutive month cost reports to establish the
payment limit for specified provider-based RHCs as proposed.
C. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and
Phase-In of Payment Reductions, and Policies for Specimen Collection
Fees and Travel Allowance for Clinical Diagnostic Laboratory Tests
1. Background on the Clinical Laboratory Fee Schedule
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule
(CLFS), with certain exceptions, under section 1833(a), (b), and (h) of
the Act. Under the previous payment system, CDLTs were paid based on
the lesser of: (1) the amount billed; (2) the local fee schedule amount
established by the Medicare Administrative Contractor (MAC); or (3) a
national limitation amount (NLA), which is a percentage of the median
of
[[Page 69742]]
all the local fee schedule amounts (or 100 percent of the median for
new tests furnished on or after January 1, 2001). In practice, most
tests were paid at the NLA. Under the previous payment system, the CLFS
amounts were updated for inflation based on the percentage change in
the Consumer Price Index for All Urban Consumers (CPI-U), and reduced
by a productivity adjustment and other statutory adjustments, but were
not otherwise updated or changed. Coinsurance and deductibles generally
do not apply to CDLTs paid under the CLFS.
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for CDLTs under the CLFS. In the June 23,
2016 Federal Register (81 FR 41036), we published a final rule entitled
Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS
final rule), that implemented section 1834A of the Act at 42 CFR part
414, subpart G.
Under the CLFS final rule, ``reporting entities'' must report to
CMS during a ``data reporting period'' ``applicable information''
collected during a ``data collection period'' for their component
``applicable laboratories.'' The first data collection period occurred
from January 1, 2016 through June 30, 2016. The first data reporting
period occurred from January 1, 2017 through March 31, 2017. On March
30, 2017, we announced a 60-day period of enforcement discretion for
the application of the Secretary's potential assessment of civil
monetary penalties (CMPs) for failure to report applicable information
with respect to the initial data reporting period.\157\
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\157\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we
solicited public comments from applicable laboratories and reporting
entities to better understand their experiences with data reporting,
data collection, and other compliance requirements for the first data
collection and reporting periods. We discussed these comments in the CY
2018 PFS final rule (82 FR 53181 through 53182) and stated that we
would consider the comments for potential future rulemaking or
guidance.
As part of the CY 2019 Medicare PFS rulemaking, we finalized two
changes to the definition of ``applicable laboratory'' at Sec. 414.502
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850, 35855
through 35862). First, we excluded Medicare Advantage (MA) plan
payments under Part C from the denominator of the Medicare revenues
threshold calculation, in an effort to broaden the types of
laboratories qualifying as applicable laboratories. Specifically,
excluding MA plan payments could allow additional laboratories of all
types serving a significant population of beneficiaries enrolled in
Medicare Part C to meet the majority of Medicare revenues threshold and
potentially qualify as applicable laboratories (if they also meet the
low expenditure threshold) and report data to CMS during the data
reporting period. Because MA plan payments are now excluded from the
total Medicare revenues calculation, the denominator amount (total
Medicare revenues) would decrease. If the denominator amount decreases,
the likelihood increases that a laboratory would qualify as an
applicable laboratory. This is because the laboratory's PFS and CLFS
revenues are being compared to a lower total Medicare payment amount
than what they would have been compared to if MA plan payments remained
in the denominator. Second, consistent with our goal of obtaining a
broader representation of laboratories that could potentially qualify
as applicable laboratories and report data, we also amended the
definition of applicable laboratory to include hospital outreach
laboratories that bill Medicare Part B using the CMS-1450 14x Type of
Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
In general, under section 1834A of the Act, the payment amount for
each CDLT on the CLFS furnished beginning January 1, 2018, is based on
the applicable information collected during the data collection period
and reported to CMS during the data reporting period, and is equal to
the weighted median of the private payor rates for the test. The
weighted median is calculated by arraying the distribution of all
private payor rates, weighted by the volume for each payor and each
laboratory. The payment amounts established under the CLFS are not
subject to any other adjustment, such as geographic, budget neutrality,
or annual update, as required by section 1834A(b)(4)(B) of the Act.
Additionally, section 1834A(b)(3) of the Act, implemented at Sec.
414.507(d), provides for a phase-in of payment reductions, limiting the
amounts the CLFS rates for each CDLT (that is not a new advanced
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as
compared to the payment rates for the preceding year. Under the
provisions enacted by section 216(a) of PAMA, for the first 3 years
after implementation (CY 2018 through CY 2020), the reduction cannot be
more than 10 percent per year, and for the next 3 years (CY 2021
through CY 2023), the reduction cannot be more than 15 percent per
year. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA,
for CDLTs that are not ADLTs, the data collection period, data
reporting period, and payment rate update occur every 3 years. As such,
the second data collection period for CDLTs that are not ADLTs occurred
from January 1, 2019 through June 30, 2019, and the next data reporting
period was scheduled to take place from January 1, 2020 through March
31, 2020, with the next update to the Medicare payment rates for these
tests based on that reported applicable information scheduled to take
effect as of January 1, 2021.
Section 216(a) of PAMA established a new subcategory of CDLTs known
as ADLTs, with separate reporting and payment requirements under
section 1834A of the Act. The definition of an ADLT is set forth in
section 1834A(d)(5) of the Act and implemented at Sec. 414.502.
Generally, under section 1834A(d) of the Act, the Medicare payment
rate for a new ADLT is equal to its actual list charge during an
initial period of 3 calendar quarters. After the new ADLT initial
period, ADLTs are paid using the same methodology based on the weighted
median of private payor rates as other CDLTs. However, under section
1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs
occur annually instead of every 3 years.
Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101) and is
available on the CMS website.\158\
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\158\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
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3. Previous Statutory Revisions to the Data Reporting Period and Phase-
In of Payment Reductions
Section 105(a) of the Further Consolidated Appropriations Act, 2020
(FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718
of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES
Act) (Pub. L. 116-136, enacted on March 27, 2020), revised the CLFS
requirements for the next data reporting period for CDLTs that are not
ADLTs under section 1834A of the Act. Additionally, the CARES Act
revised the phase-in of payment reductions under section 1834A of the
Act. Specifically, section 105(a)(1) of the
[[Page 69743]]
FCAA amended the data reporting requirements in section 1834A(a) of the
Act to delay the next data reporting period for CDLTs that are not
ADLTs by 1 year, so that data reporting would be required during the
period of January 1, 2021 through March 31, 2021; the 3-year data
reporting cycle for CDLTs that are not ADLTs would resume after that
data reporting period. Section 105(a)(1) of the FCAA also specified
that the data collection period that applied to the data reporting
period of January 1, 2021 through March 30, 2021 would be the period of
January 1, 2019 through June 30, 2019, which was the same data
collection period that would have applied absent the amendments. In
addition, section 105(a)(2) of the FCAA amended section 1834A(b)(3) of
the Act regarding the phase-in of payment reductions to provide that
payments may not be reduced by more than 10 percent as compared to the
amount established for the preceding year through CY 2020, and for CYs
2021 through 2023, payment may not be reduced by more than 15 percent
as compared to the amount established for the preceding year. These
statutory changes were consistent with our regulations implementing the
private payor rate-based CLFS at Sec. 414.507(d) (81 FR 41036).
Subsequently, section 3718 of the CARES Act further amended the
data reporting requirements for CDLTs that are not ADLTs and the phase-
in of payment reductions under the CLFS. Specifically, section 3718(a)
of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the
next data reporting period for CDLTs that are not ADLTs by one
additional year, to require data reporting during the period of January
1, 2022 through March 31, 2022. As amended by the CARES Act, section
1834A(a)(1)(B) of the Act provided that in the case of reporting with
respect to CDLTs that are not ADLTs, the Secretary shall revise the
reporting period under subparagraph (A) such that: (i) no reporting is
required during the period beginning January 1, 2020, and ending
December 31, 2021; (ii) reporting is required during the period
beginning January 1, 2022, and ending March 31, 2022; and (iii)
reporting is required every 3 years after the period described in
clause (ii).
The CARES Act did not modify the data collection period that
applied to the next data reporting period for these tests. Thus, under
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of
the FCAA, the next data reporting period for CDLTs that are not ADLTs
(January 1, 2022 through March 31, 2022) would have been based on the
data collection period of January 1, 2019 through June 30, 2019.
Section 3718(b) of the CARES Act further amended the provisions in
section 1834A(b)(3) of the Act regarding the phase-in of payment
reductions under the CLFS. First, it extended the statutory phase-in of
payment reductions resulting from private payor rate implementation by
an additional year, that is, through CY 2024. It further amended
section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable
percent for CY 2021 is 0 percent, meaning that the payment amount
determined for a CDLT for CY 2021 shall not result in any reduction in
payment as compared to the payment amount for that test for CY 2020.
Section 3718(b) of the CARES Act further amended section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent will apply for CYs 2022 through 2024, instead of CYs 2021
through 2023.
In the CY 2021 PFS rulemaking (85 FR 50210 through 50211 and 85 FR
84693 through 84694), in accordance with section 105(a) of the FCAA and
section 3718 of the CARES Act, we proposed and finalized conforming
changes to the data reporting and payment requirements at 42 CFR part
414, subpart G. Specifically, we finalized revisions to Sec. 414.502
to update the definitions of both the data collection period and data
reporting period, specifying that for the data reporting period of
January 1, 2022 through March 31, 2022, the data collection period is
January 1, 2019 through June 30, 2019. We also revised Sec.
414.504(a)(1) to indicate that initially, data reporting begins January
1, 2017 and is required every 3 years beginning January 2022. In
addition, we finalized conforming changes to our requirements for the
phase-in of payment reductions to reflect the CARES Act amendments.
Specifically, we finalized revisions to Sec. 414.507(d) to indicate
that for CY 2021, payment may not be reduced by more than 0.0 percent
as compared to the amount established for CY 2020, and for CYs 2022
through 2024, payment may not be reduced by more than 15 percent as
compared to the amount established for the preceding year.
4. Additional Statutory Revisions to the Data Reporting Period and
Phase-In of Payment Reductions
Section 4 of the Protecting Medicare and American Farmers from
Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, enacted on December 10,
2021) made additional revisions to the CLFS requirements for the next
data reporting period for CDLTs that are not ADLTs and to the phase-in
of payment reductions under section 1834A of the Act. Specifically,
section 4(b) of PMAFSCA amended the data reporting requirements in
section 1834A(a) of the Act to delay the next data reporting period for
CDLTs that are not ADLTs by 1 year, so that data reporting would be
required during the period of January 1, 2023 through March 31, 2023;
the 3-year data reporting cycle for CDLTs that are not ADLTs would
resume after that data reporting period. As amended by section 4 of
PMAFSCA, section 1834A(a)(1)(B) of the Act now provides that in the
case of reporting with respect to CDLTs that are not ADLTs, the
Secretary shall revise the reporting period under subparagraph (A) such
that--(i) no reporting is required during the period beginning January
1, 2020, and ending December 31, 2022; (ii) reporting is required
during the period beginning January 1, 2023, and ending March 31, 2023;
and (iii) reporting is required every 3 years after the period
described in clause (ii).
Section 4 of PMAFSCA does not modify the data collection period
that applies to the next data reporting period for these tests. Thus,
under section 1834A(a)(4)(B) of the Act, as amended by section
105(a)(1) of the FCAA, the next data reporting period for CDLTs that
are not ADLTs (January 1, 2023 through March 31, 2023) will continue to
be based on the data collection period of January 1, 2019 through June
30, 2019, as defined in Sec. 414.502.
Section 4 of PMAFSCA further amends the provisions in section
1834A(b)(3) of the Act regarding the phase-in of payment reductions
under the CLFS. First, it extends the statutory phase-in of payment
reductions resulting from private payor rate implementation by an
additional year, that is, through CY 2025. It further amends section
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent
for each of CY 2021 and 2022 is 0 percent, meaning that the payment
amount determined for a CDLT for CY 2021 and 2022 shall not result in
any reduction in payment as compared to the payment amount for that
test for CY 2020. Section 4(a) of PMAFSCA further amends section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent will apply for CYs 2023 through 2025, instead of CYs 2022
through 2024.
5. Conforming Regulatory Changes
In accordance with section 4(b) of PMAFSCA, in the CY 2023 PFS
proposed rule (87 FR 46068 through
[[Page 69744]]
46070), we proposed to make certain conforming changes to the data
reporting and payment requirements at 42 CFR part 414, subpart G.
Specifically, we proposed to revise Sec. 414.502 to update the
definitions of both the ``data collection period'' and ``data reporting
period,'' specifying that for the data reporting period of January 1,
2023 through March 31, 2023, the data collection period is January 1,
2019 through June 30, 2019. We also proposed to revise Sec.
414.504(a)(1) to indicate that initially, data reporting begins January
1, 2017 and is required every 3 years beginning January 2023. In
addition, we proposed to make conforming changes to our requirements
for the phase-in of payment reductions to reflect the amendments in
section 4(b) of PMAFSCA. Specifically, we proposed to revise Sec.
414.507(d) to indicate that for CY 2022, payment may not be reduced by
more than 0.0 percent as compared to the amount established for CY
2021, and for CYs 2023 through 2025, payment may not be reduced by more
than 15 percent as compared to the amount established for the preceding
year.
We noted that the CYs 2022 and 2023 CLFS payment rates for CDLTs
that are not ADLTs are based on applicable information collected in the
data collection period of January 1, 2016 through June 30, 2016. We
explained that under current law, the CLFS payment rates for CY 2024
through CY 2026 for these tests will be based on applicable information
collected during the data collection period of January 1, 2019 through
June 30, 2019 and reported to CMS during the data reporting period of
January 1, 2023 through March 31, 2023.
The following is a summary of the public comments received on the
proposed conforming regulatory changes and our responses:
Comment: Several commenters supported our proposal to revise
Sec. Sec. 414.502, 414.504 and 414.507 to conform with the current
statutory provisions governing data reporting and payment for CDLTs on
the CLFS.
Response: We appreciate the commenters' support for these
regulatory changes that reflect the recent statutory revisions required
by section 4 of PMAFSCA.
Comment: One commenter requested that the CLFS data collection
period be revised to January 1, 2022, through June 30, 2022, from the
current data collection period of January 1, 2019, through June 30,
2019. The commenter asserted that such a change would serve to better
reflect the current market conditions and private payor rates for
laboratory tests.
Response: We note that section 4 of PMAFSCA did not modify the data
collection period that applies to the next data reporting period for
CDLTs that are not ADLTs. Therefore, under section 1834A(a)(4)(B) of
the Act, as amended by section 105(a)(1) of the FCAA, the next data
reporting period for CDLTs that are not ADLTs (January 1, 2023, through
March 31, 2023) will continue to be based on the data collection period
of January 1, 2019, through June 30, 2019, as defined in Sec. 414.502.
Because this requirement is statutory, we are unable to modify the data
collection period.
Comment: Several commenters suggested that CMS delay implementation
of the phase-in of payment reductions under the CLFS for CY 2023 and
instead utilize a 0.0 percent payment reduction for CY 2023.
Response: We note that the phase-in of payment reductions to the
CLFS payment amounts is statutory; therefore, we are unable to delay
implementation and apply 0.0 percent payment reduction for CY 2023. The
statute expressly states that there will be a 0.0 payment reduction for
CY 2022 and, for CYs 2023 through 2025, payment may not be reduced by
more than 15 percent as compared to the amount established for the
preceding year.
In consideration of these public comments and in accordance with
section 4(b) of PMAFSCA, we are finalizing the proposed conforming
changes to the data reporting and payment requirements at 42 CFR part
414, subpart G, as proposed.
6. Laboratory Specimen Collection Fee and Travel Allowance Policies
As discussed in the CY 2023 PFS proposed rule (87 FR 46070 through
46074), section 1833(h)(3) of the Act generally requires the Secretary
to provide for and establish a nominal fee for specimen collection for
laboratory testing and a fee to cover transportation and personnel
expenses for trained personnel to collect specimens from homebound
patients and inpatients (not in a hospital), in addition to the amounts
provided under the Medicare CLFS. We proposed to codify our
longstanding specimen collection fee policies at Sec. 414.523(a)(1)
and our travel allowance policies at Sec. 414.523(a)(2), as well as
certain changes to modify or clarify those policies.
a. Background on Laboratory Specimen Collection Fee Policy
Medicare Part B, which includes a variety of outpatient services,
generally covers medically necessary CDLTs when a doctor or non-
physician practitioner orders them. Medically necessary CDLTs generally
are not subject to coinsurance or deductible. Section 1833(h)(3)(A) of
the Act provides that, in addition to the amounts provided under fee
schedules (for tests furnished before January 1, 2017) or under section
1834A of the Act (for tests furnished on or after January 1, 2017), the
Secretary shall provide for and establish a nominal fee to cover the
appropriate costs in collecting the sample on which a CDLT was
performed and for which payment is made under Medicare Part B, except
that not more than one such fee may be provided with respect to samples
collected in the same encounter. As detailed in the proposed rule, we
provided manual instructions regarding payment of the nominal specimen
collection fee in the Medicare Claims Processing Manual Pub. 100-04,
chapter 16, section 60.1,\159\ but we have not reflected these general
policies in our regulations.\160\ The HCPCS codes for the nominal
specimen collection fees currently listed on the CLFS (HCPCS codes
36415, P9612, and P9615 \161\) have a payment rate of $3. Neither the
annual deductible nor the 20 percent coinsurance for Medicare apply to
the specimen collection fees or travel allowance for laboratory tests.
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\159\ The Medicare Claims Processing Manual is available on the
CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS018912.
\160\ In 1993, we proposed to implement the payment
methodologies for the specimen collection fee and travel allowance
in the regulations, see 53 FR 43837 through 43838, but did not
finalize those proposals.
\161\ HCPCS codes and long descriptors: 36415 (Insertion of
needle into vein for collection of blood sample); P9612
(Catheterization for collection of specimen, single patient, all
places of); P9615 (Catheterization for collection of specimen(s)
(multiple patients)).
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Section 216(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted April 1, 2014) added section
1834A(b)(5) to the Act, which increases by $2 the nominal fee that
would otherwise apply under section 1833(h)(3)(A) of the Act for a
specimen collected from an individual in a skilled nursing facility
(SNF) or by a laboratory on behalf of a HHA. Therefore, effective April
1, 2014, the nominal fee that would otherwise apply for a specimen
collected from an individual in a SNF or by a laboratory on behalf of a
HHA is $5, and the relevant HCPCS code is G0471.\162\ We
[[Page 69745]]
implemented this provision in our regulations at Sec. 414.507(f).
However, as we discussed in the proposed rule, we proposed to codify
our specimen collection fee policies in Sec. 414.523(a)(1), including
moving that provision from Sec. 414.507(f) to Sec. 414.523(a)(1)(iv).
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\162\ HCPCS code and descriptor: G0471 (Collection of venous
blood by venipuncture or urine sample by catheterization from an
individual in a skilled nursing facility (SNF) or by a laboratory on
behalf of a home health agency (HHA)).
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In the ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' interim
final rule with comment period (IFC), which appeared in the Federal
Register on April 6, 2020 (85 FR 19230), we established that Medicare
would pay a nominal specimen collection fee and associated travel
allowance to independent laboratories for the collection of specimens
for COVID-19 CDLTs for homebound and non-hospital inpatients (85 FR
19256 through 19258). Under this policy, the nominal specimen
collection fee for COVID-19 testing for homebound and non-hospital
inpatients generally is $23.46 and for individuals in a SNF and
individuals whose samples are collected by laboratory on behalf of an
HHA is $25.46. We indicated in that IFC that this specimen collection
fee policy was established for the duration of the PHE for COVID-19 (85
FR 19256) and noted in that IFC and subsequent rules (86 FR 39309; 86
FR 65327) that this policy will end once the PHE for the COVID-19
pandemic has ended.
In the CY 2022 PFS proposed rule (86 FR 39310), we requested broad
comments on our policies for specimen collection fees for consideration
for possible updates to those policies in the future through notice and
comment rulemaking. We requested comments regarding the nominal
specimen collection fees for trained personnel to collect specimens
from homebound patients and inpatients (not in a hospital), how
specimen collection practices may have changed as a result of, or from
insight gained during, the PHE for COVID-19, and what additional
resources might be needed for specimen collection for COVID-19 CDLTs
and other tests after the PHE ends, as well as comments related to the
calculation of costs for transportation and personnel expenses for
trained personnel to collect specimens from such patients. In the CY
2022 PFS final rule (86 FR 65327 through 65328), we described the
comments received and provided responses to those comments. We
expressed appreciation for the comments regarding the nominal specimen
collection fees for the collection of specimens for COVID-19 CDLTs and
acknowledged that the types of resources utilized and supplies needed
for specimen collection have been influenced by the PHE for COVID-19.
We stated that although we would not extend the increased payment
amount beyond the PHE, we would take the feedback received from the
comment solicitation into consideration for possible future rulemaking
and guidance.
b. Longstanding Laboratory Specimen Collection Fee Policies and
Practices
In the CY 2023 PFS proposed rule (87 FR 46071 through 46073), we
explained that CMS has longstanding policies and practices regarding
the statutory requirements under section 1833(h)(3)(A) of the Act for
the laboratory specimen collection fee, which are currently described
in the Medicare Claims Processing Manual Pub. 100-04, chapter 16, Sec.
60.1. However, we do not have corresponding regulations text related to
the manual guidance and some of the manual guidance is no longer
applicable. The manual guidance specifies when a specimen fee is
allowed and not allowed. In particular, the manual provides guidance on
the following topics: (1) specimen drawing by a physician; (2) specimen
drawing by an independent laboratory; (3) specimen drawing for a
dialysis patient; and (4) the coding requirements for specimen
collection. We noted that laboratory services, including specimen
collection and travel for specimen collection, paid under the CLFS must
be reasonable and necessary as required under section 1862(a)(1)(A) of
the Act.
Specifically, the guidance provides that a specimen collection fee
is allowed in circumstances such as drawing a blood sample through
venipuncture (that is, inserting into a vein a needle with syringe or
vacutainer to draw the specimen) or collecting a urine sample by
catheterization. A specimen collection fee is not allowed for a throat
culture or a routine capillary puncture for clotting or bleeding time.
Additionally, the specimen fee will not be paid to anyone who has not
extracted the specimen. The manual guidance addresses the number of
specimen collection fees allowed for each specimen type per patient
encounter. The manual also addresses how to treat a series of
specimens; when a series of specimens is required to perform a single
test (for example, a glucose tolerance test), the series is treated as
a single encounter.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.1)
describes specimen collection fees for physicians. Specifically, the
manual states that Medicare allows a specimen collection fee for
physicians only when: (1) it is the accepted and prevailing practice
among physicians in the locality to make separate charges for drawing
or collecting a specimen; and (2) it is the customary practice of the
physician performing such services to bill separate charges for drawing
or collecting the specimen.
We noted that, in reviewing the specimen collection criteria for
physicians to be paid for this service, we had concerns regarding
outdated terminology and the eligibility criteria for these suppliers
to bill Medicare for a specimen collection fee. For example, we found
that these criteria were established prior to January 1, 1992, which is
when Medicare began to pay for physicians' services under section 1848
of the Act (56 FR 59502). Since that time, the provision of laboratory
services and physicians' services have evolved. Therefore, we evaluated
those criteria as they would apply today. In consideration of current
standards of practice, we analyzed utilization of the specimen
collection Current Procedural Terminology (CPT[supreg]) codes to
determine if the physician office setting is billing for this fee. We
found that, in 2019, office-based physician and nonphysician
practitioners had 67.4 million claims billed with specimen collection,
comprising 31.1 percent of all specimen collection claims.
We also looked to the PFS to see if there are similar services that
physicians and nonphysician practitioners can bill and be paid for
under section 1848 of the Act. We found that there are codes available
that address collection of blood, for example, CPT[supreg] codes 36410
(Venipuncture, age 3 years or older, necessitating the skill of a
physician or other qualified health care professional (separate
procedure), for diagnostic or therapeutic purposes (not to be used for
routine venipuncture)). These findings confirmed specimen collection
occurs in the physician's office setting and there are coding options
to bill for that service via the PFS when applicable. Therefore, we
noted that we believed the criteria currently included in the manual
for physician eligibility for the CLFS specimen collection fee no
longer apply. We stated that we would not reflect those policies in
regulation and would remove this section of the manual accordingly.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.2)
describes policies for specimen drawing by independent laboratories.
Specifically, the manual states the following:
[[Page 69746]]
Medicare allows separate charges made by laboratories for drawing
or collecting specimens whether or not the specimens are referred to
hospitals or independent laboratories. The laboratory does not bill for
routine handling charges where a specimen is referred by one laboratory
to another. Medicare allows payment for a specimen collection fee when
it is medically necessary for a laboratory technician to draw a
specimen from either a nursing home patient or homebound patient.
Payment for the specimen collection fee is made based on the CLFS. The
technician must personally draw the specimen, for example, venipuncture
or urine sample by catheterization. Medicare does not allow a specimen
collection fee to the visiting technician if a patient in a facility
is: (1) not confined to the facility; or (2) the facility has personnel
on duty qualified to perform the specimen collection. Medical necessity
for such services exists, for example, where a laboratory technician
draws a blood specimen from a homebound or an institutionalized
patient. A patient need not be bedridden to be homebound. However,
where the specimen is a type that would require only the services of a
messenger and would not require the skills of a laboratory technician,
for example, urine or sputum, a specimen pickup service would not be
considered medically necessary. The manual then refers to the Medicare
Benefit Policy Manual, Chapters 7 and 15 of Pub. 100-02, for a
discussion of ``homebound'' and a more complete definition of a
medically necessary laboratory service to a homebound or an
institutional patient.
Under sections 1814(a) and 1835(a) of the Act, an individual shall
be considered to be ``homebound'' or ``confined to his home'' if the
individual has a condition, due to an illness or injury, that restricts
the ability of the individual to leave his or her home except with the
assistance of another individual or the aid of a supportive device
(such as crutches, a cane, a wheelchair, or a walker), or if the
individual has a condition such that leaving his or her home is
medically contraindicated. While an individual does not have to be
bedridden to be considered ``confined to his home,'' the condition of
the individual should be such that there exists an inability to leave
home such that leaving home requires a considerable and taxing effort
by the individual. Moreover, Sec. 424.22(a)(1)(ii) describes homebound
for the purposes of the provision of Medicare home health services as
home health services are or were required because the individual is or
was confined to the home, as defined in sections 1835(a) and 1814(a) of
the Act, except when receiving outpatient services. Additionally,
chapter 15 of the Medicare Benefit Policy Manual \163\ Section 60.4.1--
``Definition of Homebound Patient Under the Medicare Home Health (HH)
Benefit'' describes the definition of homebound in that the patient is
confined to his/her home, which has two criteria: (1) the patient must
either, because of illness or injury, need the aid of supportive
devices such as crutches, canes, wheelchairs, and walkers; the use of
special transportation; or the assistance of another person in order to
leave their place of residence; or (2) otherwise have a condition such
that leaving his or her home is medically contraindicated. The patient
must also meet two additional requirements defined in criterion two
such that there must exist an inability to leave home; and leaving home
must require a considerable and taxing effort.
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\163\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.2)
also explains the information that must be included on an independent
laboratory claim for specimen drawing. Specifically, the manual states
that in addition to the usual information required on claim forms
(including the name of the prescribing physician), all independent
laboratory claims for such specimen drawing ordered by a physician
should be appropriately annotated, for example, ``patient confined to
home,'' ``patient homebound,'' or ``patient in nursing home, no
qualified person on duty to draw specimen.'' The manual states that A/B
MACs (B) must assure the validity of the annotation through scientific
claims samples, as well as through regular bill review techniques.
(This could be done by use of the information in A/B MAC (B) files, and
where necessary, contact with the ordering physician.) If a physician
requests an independent laboratory to obtain specimens in situations
which do not meet, or without regard to whether they meet, medical
necessity criteria in Medicare Benefit Policy Manual, Chapter 15, the
manual provides that an educational contact with the ordering physician
is warranted and, where necessary, corroborating documentation should
be obtained on claims until the A/B MAC (B) is assured that the
physician prescribes such services only when the criteria are met. The
manual states that the specimen collection fee is paid based on the
location of the independent laboratory where the test is performed and
is billed in conjunction with a covered laboratory test.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.3)
describes specimen drawing for dialysis patients. It states that, with
the implementation of the End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS), effective for claims with dates of service on or
after January 1, 2011, all ESRD-related laboratory services are
included in the ESRD PPS base rate.\164\ Clinical laboratory tests for
dialysis patients can be performed individually or in predetermined
groups on automated profile equipment. The manual states that a
specimen collection fee determined by CMS will be allowed only in the
following circumstances:
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\164\ The manual refers to the Medicare Benefit Policy Manual,
Chapter 11, for a description of laboratory services included in the
composite rate.
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Drawing a blood sample through venipuncture (that is,
inserting into a vein a needle with a syringe or vacutainer to draw the
specimen).
Collecting a urine sample by catheterization.
The manual provides that special rules apply when such services are
furnished to dialysis patients. That is, the specimen collection fee is
not separately payable for patients dialyzed in the ESRD facility or
for patients dialyzed at home. A specimen collection fee is also not
separately payable when an ESRD facility is collecting a specimen for
transplant eligibility or other transplant requirements. Payment for
specimen collection is included under the ESRD PPS, regardless of
whether the laboratory test itself is designated as payable under the
ESRD PPS as a renal dialysis service or is separately billable by the
ESRD facility with the AY modifier (see Medicare Claims Processing
Manual, chapter 16, Sec. 40.6). Fees for taking specimens in the
hospital setting, but outside of the dialysis unit, for use in
performing laboratory tests not included in the ESRD PPS base rate, may
be paid separately.
We stated that we believed that the implementation of the ESRD PPS
made the specimen collection provision for ESRD beneficiaries in the
ESRD facility setting obsolete. That is, prior to the ESRD PPS, ESRD
facilities could be paid for laboratory services furnished to ESRD
beneficiaries that were considered to be separately payable. Under the
prior composite rate system, ESRD
[[Page 69747]]
facilities with the appropriate Clinical Laboratory Improvement
Amendments (CLIA) certification could bill Medicare Part B directly and
be paid based on the CLFS for certain laboratory tests, and when
appropriate, for a specimen collection fee.\165\ In implementing the
ESRD PPS, we also implemented consolidated billing requirements in the
CY 2011 ESRD PPS final rule (75 FR 49168 through 49173). In that ESRD
PPS final rule, we stated that we established these consolidated
billing requirements because the ESRD PPS provides an all-inclusive
payment for renal dialysis services and home dialysis items and
services and the ESRD facility is responsible for all of the renal
dialysis services that its patients receive. We further explained that
items and services that were paid separately under the basic case-mix
adjusted composite rate (such as laboratory tests), would no longer be
billed for by other entities (such as laboratories), and therefore,
payment for these services would be made only to the ESRD facility so
that duplicate payment is not made by Medicare (75 FR 49168).
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\165\ Pub. 100-02, Chapter 11, Section 20.2.E.2 and 3. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf.
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Additionally, section 1881(b)(14)(B)(i) and (iv) of the Act
provides that items and services included in the prior composite rate
and other diagnostic laboratory tests not reflected in the composite
rate that are furnished to individuals for the treatment of ESRD are
renal dialysis services that must be included as part of the ESRD PPS
bundled payment. In the CY 2011 ESRD PPS final rule, we explained that
patients with ESRD often have comorbid conditions which would require
many of the same laboratory tests as those required to monitor a
patient's ESRD (75 FR 49168). In that ESRD PPS final rule, we
acknowledged that it may be difficult to differentiate between a renal
dialysis service laboratory test and tests ordered for non-renal
dialysis service conditions. Therefore, to ensure proper payment in all
settings, as part of the consolidated billing approach, we provided
ESRD facilities and independent laboratories the ability to identify
non-renal dialysis service laboratory tests, by using the AY modifier,
which allows for separate payment under Medicare Part B (75 FR 49168
through 49169). We noted that while this longstanding policy permits
ESRD facilities to be paid separately for the non-renal dialysis
service laboratory tests, the specimen collection fee is no longer
available since staff time used to collect specimens is considered to
be a composite rate service (Sec. 413.171), and therefore, payment for
specimen collection is made through the ESRD PPS bundled payment to the
ESRD facility. Therefore, we stated that we believed this section of
the manual guidance describing specimen drawing for dialysis patients
is no longer applicable, and we would not reflect this policy in
regulation and would remove this section of the manual accordingly. We
noted when an ESRD beneficiary goes to an independent laboratory or a
hospital setting, the same payment rules would apply for specimen
collection as they would for a non-ESRD beneficiary for that setting.
Lastly, the Medicare Claims Processing Manual (chapter 16, Sec.
60.1.4) includes coding requirements for the specimen collection fees.
Specifically, the following HCPCS codes and terminology must be used:
36415--Collection of venous blood by venipuncture.
G0471--Collection of venous blood by venipuncture or urine
sample by catheterization from an individual in a skilled nursing
facility (SNF) or by a laboratory on behalf of a home health agency
(HHA).
P9612--Catheterization for collection of specimen, single
patient, all places of service.
P9615--Catheterization for collection of specimen(s)
(multiple patients).
c. Codification of the Laboratory Specimen Collection Fee Policy in
Regulation
As noted previously, most of our laboratory specimen collection fee
policies are not reflected in the CLFS regulations. In the CY 2023 PFS
proposed rule, we proposed the laboratory specimen collection fee
policies we would include in regulations.
Section 1833(h)(3) of the Act specifies that payment amounts for
the specimen collection fee and travel allowance are ``in addition'' to
the payment amounts for CDLTs on the CLFS. As Sec. 414.507 pertains to
payment for CDLTs, we stated that we believed it would be appropriate
to create a separate regulation to more clearly reflect that payment
for the specimen collection fee and travel allowance is in addition to
payment for CDLTs. We proposed to create Sec. 414.523 titled Payment
for laboratory specimen collection fee and travel allowance. We
proposed to specify in Sec. 414.523(a) that in addition to the payment
amounts provided for CDLTs, new CDLTs, and new ADLTs, CMS would pay a
specimen collection fee and a travel allowance. In Sec. 414.523(a)(1),
we proposed that we would reflect the longstanding specimen collection
fee policies described in the manual that continue to be applicable. As
noted in the proposed rule, we would not reflect in the regulation the
specimen collection fee policies that are no longer applicable--
specifically, the policies relating to physician eligibility for
specimen collection and specimen drawing for dialysis patients--and
would remove those policies from the manual.
First, we proposed that Sec. 414.523(a)(1) would specify that CMS
will pay $3 for all specimens collected in one patient encounter. As
previously stated, section 1833(h)(3)(A) of the Act requires the
Secretary to provide for and establish a nominal fee to cover the
appropriate costs in collecting the sample for laboratory testing. We
have paid $3 as the nominal specimen collection fee amount for several
years and proposed to maintain the $3 amount. We noted that the statute
specifies that the amount is ``nominal'' and we believed $3 is an
appropriate nominal amount to recognize the costs associated with
specimen collection. We also stated that we believed that in enacting
section 216(a) of PAMA, Congress recognized CMS's authority to
establish the specific nominal fee amount as $3 when it added section
1834A(b)(5) of the Act to increase by $2 the nominal fee that would
otherwise apply under section 1833(h)(3)(A) of the Act for a specimen
collected from an individual in a SNF or by a laboratory on behalf of
an HHA. We solicited comments on the proposal to maintain the $3
nominal specimen collection fee amount, including how this amount could
be updated.
We proposed to move and clarify the provision in our regulations
regarding the increased specimen collection fee under section
1834A(b)(5) of the Act, as discussed in the previous paragraph. We
explained that we implemented this PAMA requirement in a Medicare
Change Request (CR) transmittal effective December 1, 2014 (Transmittal
#R3056CP; CR #8837) and ultimately finalized this policy in Sec.
414.507(f).\166\ The CR provides that, in the case of a specimen
collected from an individual in a SNF or from an individual by a
laboratory on behalf of a HHA (billed using new HCPCS code, G0471
(Collection of venous blood by venipuncture or urine sample by
catheterization from an individual in a skilled nursing facility (SNF)
or by a laboratory on behalf of a home health
[[Page 69748]]
agency (HHA))), the nominal fee that would otherwise apply under
section 1833(h)(3)(A) of the Act shall be increased by $2, from $3 to
$5, in accordance with section 216(a) of the PAMA. The specimen
collection fee is raised from $3 to $5 only when the specimen is being
collected by a laboratory technician and when the specimen is from an
individual in either a SNF or HHA. We proposed that this requirement,
which is currently reflected in Sec. 414.507(f), would be moved to
Sec. 414.523(a)(1)(iv) and would be revised to state that beginning
April 1, 2014, for a specimen collected from a Medicare beneficiary in
a SNF or on behalf of an HHA, the specimen collection fee otherwise
paid under paragraph (a)(1) of Sec. 414.523 is increased by $2.
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\166\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3056CP.pdf.
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In addition, we proposed to include in regulation that one specimen
collection fee would be allowed for each single patient encounter. This
means that, if different types or multiple specimens are drawn from one
patient, only one specimen collection fee would be allowed. We noted in
the proposed rule that we believed this policy is consistent with
section 1833(h)(3)(A) of the Act, which provides that not more than one
such fee may be provided under this paragraph with respect to samples
collected in the same encounter. We proposed to reflect this policy in
Sec. 414.523(a)(1) by indicating that CMS pays $3 for ``all specimens
collected in one patient encounter.''
In Sec. 414.523(a)(1)(i) through (iii), we proposed to indicate
the specimen collection requirements that must be met for a specimen
collection fee to be payable are as follows. The specimen is: used to
perform a CDLT paid under the CLFS regulations in 42 CFR part 414,
subpart G; collected by a trained technician from a Medicare
beneficiary who is homebound as described in 42 CFR 424.22(a)(1)(ii) or
is a non-hospital inpatient, but only when no qualified personnel are
available at the facility to collect the specimen; of the following
type--blood specimen collected through venipuncture or a urine sample
collected by catheterization.
In Sec. 414.523(a)(1)(ii), we proposed to clarify the requirement
that the specimen must be collected by a ``trained technician.''
Section 1833(h)(3) of the Act refers to staff providing specimen
collection services as ``trained personnel'' whereas the Medicare
Claims Processing Manual, chapter 16, section 60.2, refers to ``the
technician.'' The United States Bureau of Labor Statistics (BLS)
defines clinical laboratory technologists and technicians as workers
who collect samples and perform tests to analyze body fluids, tissue,
and other substances.\167\ The term ``laboratory technician'' may not
apply to those staff that would generally be providing specimen
collection services, as the staff collecting specimens may not also be
involved in analyzing the specimens. Therefore, for the purposes of our
Medicare payment policies for specimen collection and travel allowance,
we proposed to use the phrase ``trained technician'' to refer to those
staff providing specimen collection services. We noted that we believed
this clarification would more closely align the regulatory text
pertaining to specimen collection and travel allowance with the
statute.
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\167\ https://www.bls.gov/ooh/healthcare/clinical-laboratory-technologists-and-technicians.htm.
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As discussed in the proposed rule, Medicare allows payment of a
specimen collection fee when it is medically necessary for a trained
technician to draw a specimen from either a nursing home patient or
homebound patient. Medicare does not allow a specimen collection fee
for the technician if a patient in a facility is: (1) not confined to
the facility; or (2) the facility has qualified personnel available to
perform the specimen collection. We proposed to reflect in regulation
that the specimen must be collected either from a Medicare beneficiary
who is homebound as described in Sec. 424.22(a)(1)(ii), or from a non-
hospital inpatient, but only when no qualified personnel are available
at the facility to collect the specimen. We noted that we believed the
proposed requirement regarding homebound beneficiaries would be
consistent with Medicare policy, which describes home health services
requirements. We proposed to clarify that payment for specimen
collection would only be made to the laboratory when no qualified
personnel are available at the inpatient facility to collect the
specimen. We also noted that we believed the proposed clarification
would reflect the justification for ``medical necessity'' for purposes
of section 1862(a)(1) of the Act. We proposed to codify the requirement
in Sec. 414.523(a)(1)(ii)(B) but would not explicitly state the term
``medically necessary''.
We proposed to clarify that a specimen collected by a trained
technician would have to be either blood collected through venipuncture
or a urine sample collected by catheterization. We proposed to codify
the requirement in Sec. 414.523(a)(1)(iii), which would state that the
specimen collection fees are permitted for only these two types of
specimens: (1) blood collected through venipuncture or (2) a urine
sample collected by catheterization. We acknowledged that the manual
guidance (described above) uses the terms ``such as'' and ``example''
to describe the types of specimens for which specimen collection fees
are paid, which suggests that specimen collections of samples other
than blood and urine are eligible for specimen collection fees. We
noted, however, that there are only two HCPCS codes for the two types
of specimen collections, which means we do not pay, and have not been
paying, specimen collection fees for any other types of specimens.
Therefore, as discussed in the proposed rule, under our current policy
a specimen collection fee would not be payable for any other specimen
types, for example, a throat culture or a routine capillary puncture
for clotting or bleeding time.
We welcomed public comment on the proposed codification and
modification of the laboratory specimen collection fee policies. We
noted that if finalized, we would make conforming changes to the
Medicare Claims Processing Manual, Chapter 16, section 60, to reflect
changes or clarifications and remove sections that are no longer
applicable.
Lastly, we solicited comments on specimen collections performed by
physician office laboratories (POLs). As discussed in the CY 2023 PFS
proposed rule, we proposed to delete the section in the manual
regarding physician specimen collection, as codes exist to describe
these services when performed by physicians under the PFS. However, we
noted in the proposed rule that we understand that specimens may be
collected in the physician's office by POL personnel. As stated in 42
CFR 410.32(d)(1)(iii), Medicare Part B pays for covered diagnostic
laboratory tests that are furnished by the office of the patient's
attending or consulting physician if that physician is a doctor of
medicine, osteopathy, podiatric medicine, dental surgery, or dental
medicine. When the physician's office is furnishing CDLTs for its own
patients and collecting specimens for those tests, we do not believe
this would include specimen collection for homebound or non-hospital
inpatients or involve travel for specimen collection, since a POL is
not an independent laboratory. However, we sought comments on any
possible considerations for the removal of the manual section related
to POL specimen collection.
The following is a summary of the public comments received on the
laboratory specimen collection fee proposals and our responses:
[[Page 69749]]
Comment: Several commenters supported our proposal to codify
longstanding specimen collection fee policies at Sec. 414.523(a)(1),
as well as our proposal to make certain changes to modify or clarify
those policies. Other commenters appreciated the ability to be paid for
laboratory specimen collection.
Response: We appreciate the commenters' support to codify
longstanding specimen collection fee policies and make certain changes
to modify or clarify those policies, as well as commenters' support for
the payment of laboratory specimen collection required by section
1833(h)(3)(A) of the Act.
Comment: We received several comments on our proposal to maintain
the $3 fee for specimen collection for venous blood by venipuncture
(CPT[supreg] code 36415) and the $5 fee for specimen collection from a
beneficiary in a SNF or by a laboratory on behalf of a home health
agency (HCPCS code G0471). Some commenters requested that we increase
the $3 specimen collection fees, with requested amounts ranging from
$8.28 to $12, to account for labor shortages, wage increases, supplies
cost increases, and inflation. Several commenters also recommended that
CMS update the specimen collection fee for inflation by utilizing the
CPI-U for the years since the establishment of the specimen collection
fee and that CMS continue utilizing such an update for future years in
order to account for the changes in costs for resources related to
specimen collection.
One commenter that requested an increase in the specimen collection
fee amount to $8.28 supported their suggestion with an analysis of the
costs associated with collecting a blood specimen using cost data,
including supplies, wages, and benefits from three laboratories--one
that services a variety of clients, one that services physician offices
and SNFs, and one that services only SNFs--and selected the least
expensive cost provided by the three laboratories for each line item in
the cost analysis.
Several commenters requested that we increase the $3 and $5
specimen collection fee amounts to $12 and $14, respectively. The
commenters noted that the $3 amount was inadequate when it was first
implemented and the costs to provide specimen collection services have
increased exponentially since the implementation of the fee. These
commenters opined that a $12 collection fee amount is a ``nominal''
amount and is approximately one-half of the 2020 Medicare reimbursement
for CPT[supreg] code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient that may not
require the presence of a physician or other qualified health care
professional), which, though less complex than specimen collection, is
comparable in that the presenting problems are minimal, the service
does not require the presence of a physician or other health care
professional, and the service typically takes less than 5 minutes to
complete. Commenters also noted that we drew this same comparison to
CPT[supreg] code 99211 when determining a ``nominal'' fee for COVID-19
specimen collection.
One commenter stated that, in contrast to specimen collections for
venous draws billed under CPT[supreg] code 99211 for Level 1 office
visits, venous draws from patients in nursing homes are far more
challenging because nursing home patients are often being treated with
medications that affect their cognition, specimen collections may occur
in the pre-dawn hours, and many patients suffer from multiple complex
co-morbidities, which can complicate a venous draw. Additionally, the
commenter noted that technicians collecting samples from Medicare
beneficiaries in SNFs are also faced with numerous operational barriers
and that the $5 reimbursement for specimen collection from SNF patients
is approximately 80 percent less than reimbursement for a Level I
office visit billed under CPT[supreg] code 99211.
Response: We appreciate the thoughtful and detailed recommendations
and comments on our proposal to maintain the $3 nominal specimen
collection fee amount, and we recognize that some commenters believe
this longstanding nominal fee amount does not cover the costs of
specimen collection. As previously discussed, section 1833(h)(3)(A) of
the Act requires the specimen collection fee to be ``nominal,'' which
suggests that Congress did not intend it to be reimbursement for actual
or specific costs. In fact, in 2014, Congress established a requirement
in PAMA under section 1834A(b)(5) of the Act that specimens collected
from a Medicare beneficiary in a SNF or by a laboratory on behalf of an
HHA be paid an additional $2. We believe that specification of an
additional $2 amount for those types of specimen collection was some
indication Congress considered the $3 specimen collection fee at the
time to be an appropriate amount and consistent with what Congress
considered to be a ``nominal'' amount; Congress could have changed the
$3 amount when it required the additional $2 for specimens collected
from a Medicare beneficiary in a SNF or by a laboratory on behalf of an
HHA. The statute also specifies that the nominal fee must ``cover the
appropriate costs in collecting the sample.'' The history of the
laboratory specimen collection fee policy indicates that drawing,
collecting, or handling a specimen were the costs the policy was
intended to cover.168 169 170 We believe these activities
continue to be appropriate costs to be covered by the nominal specimen
collection fee. While we have long considered the $3 fee amount to be
an appropriate nominal fee to reflect those costs, based on the
comments received and our further analysis, we believe that it is
appropriate to now update the specimen collection fee amount for CY
2023, and continue to update it in subsequent years.
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\168\ See Omnibus Reconciliation Act of 1980 (OBRA), (Pub. L.
96-499), https://www.congress.gov/96/statute/STATUTE-94/STATUTE-94-Pg2599.pdf.
\169\ See section 2023 of the Deficit Reduction Act of 1984,
July 18, 1984, https://www.congress.gov/98/statute/STATUTE-98/STATUTE-98-Pg494.pdf.
\170\ https://www.ncbi.nlm.nih.gov/books/NBK223053/.
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As commenters have stated, costs related to collecting, drawing,
and handling specimens have increased over the years, with the PHE for
COVID-19 starkly highlighting those increased costs and the ongoing
need for specimen collection services. Commenters noted that the costs
of drawing, collecting, or handling specimens have also increased due
to typical inflation, among other factors, and these factors are
expected to persist even once the PHE for COVID-19 ends. We recognize
there are costs associate with the types of items and services
necessary for drawing, collecting, or handling a specimen, and we
understand there are an array of financial pressures associated with
the maintenance of supplies and retaining staff, such as supply
shortages, labor shortages, or wage increases. While the specimen
collection fee is not intended to reimburse laboratories for actual
costs incurred for drawing, collecting, or handling a specimen, we
believe updating the $3 amount for inflation is an appropriate way for
CMS to recognize that specimen collection costs do increase, and that
increasing the nominal fee by the CPI-U will address those growing
pressures.
We appreciate commenters' analysis of specimen collection costs to
justify updating the $3 amount. However, as we explained above, we do
not believe the nominal fee for specimen collection is intended to
reimburse for specific
[[Page 69750]]
costs. Therefore, we did not consider the data analysis provided by the
commenter as a source for establishing an amount. We note, however,
that the specimen collection fee amount resulting from the approach we
are finalizing, $8.57, is very close to the amount suggested by the
commenter, $8.28. We are also not accepting commenters' suggestion that
we increase the specimen collection fee to $12 because it is
approximately one-half of the 2020 Medicare reimbursement for
CPT[supreg] code 99211. Although in the April 6, 2020 IFC, we did use
CPT[supreg] code 99211 as a benchmark to establish a nominal fee for
COVID-19 specimen collection, we believe the circumstances involved for
routine specimen collection are vastly different from those involving
collecting a sample to diagnosis a novel communicable infectious
disease. As we discussed in the April 6, 2020 IFC (85 FR 19256), we had
to look to similar services in other settings of care as a potential
benchmark absent concrete information regarding the costs associated
with independent laboratories collecting such specimens for COVID-19
tests in the context of the PHE. We believe the $3.00 nominal fee is
our benchmark for recognizing the costs associated with routine
specimen collection, and deriving a fee amount based on a PFS service
of CPT[supreg] code 99211 is not applicable outside of the PHE.
As we noted above, we believe that it is appropriate to now update
the specimen collection fee amount for CY 2023, and continue to update
it in subsequent years, and we believe using the CPI-U is an
appropriate way to do both. To establish the nominal specimen
collection fee for CY 2023, we first calculated the inflation factor to
be applied to the $3.00. To derive this inflation factor, we used the
historical CPI-U from June of 2022 and divided it by the historical
CPI-U for June 1984. We selected June of 1984 as the comparison date
(that is, the date we are comparing past $3 value with present-day
value) because that is the year Congress established the CLFS and the
related laboratory specimen collection fees under section 1833(h)(3)(A)
of the Act. We selected June 2022 as the date that reflects the present
day because this will allow us to update the specimen collection fee
amount for future years to reflect historical growth for a 12-month
period in a consistent manner. This methodology, June 2022 CPI-U/June
1984 CPI-U, yielded an inflation factor of 2.857. We multiplied the
inflation factor of 2.857 by $3, which resulted in a payment rate of
$8.57 ($3 x 2.857=$8.57). Accordingly, we are finalizing $8.57 as the
nominal specimen collection fee for CY 2023. In addition, as required
by PAMA, we are increasing this amount by $2 for specimens collected
from a Medicare beneficiary in a SNF or by a laboratory on behalf of an
HHA, which results in $10.57 as the specimen collection fee amount for
specimens collected from those beneficiaries.
Comment: Several commenters requested that we utilize the CPI-U to
update the specimen collection fee amounts on an annual basis moving
forward in order to account for the impact of inflation.
Response: We appreciate the commenters' recommendations on how we
might update the specimen collection fee amounts in future years. As we
stated above, we are finalizing an increase to the specimen collection
fee amount from $3 to $8.57 for CY 2023. As we also noted above, after
considering the comments and conducting further analysis, we believe
that it is appropriate to update the nominal specimen fee to account
for inflation in subsequent years and we believe using CPI-U is an
appropriate way to account for the annual impact of inflation on costs
of drawing, collecting, or handling specimens.
Thus, we are finalizing that, beginning January 1, 2024, we will
update the specimen collection fee amount of $8.57 for each calendar
year using the 12-month percentage increase in the CPI-U of the most
recent year of data published by BLS, that is for the 12-month period
ending June 30th of the year preceding the update year. We believe that
updating the fee based on the 12-month percentage increase in the CPI-U
is consistent with other CLFS authorities such as section 1833(h)(7) of
the Act, which requires us to update the payment amount for a
diagnostic or screening pap smear laboratory test annually by a
percentage increase or decrease equal to the percentage increase or
decrease in the CPI-U, as well as other Medicare payment systems (for
example, the CLFS prior to 2018, the Ambulance Fee Schedule, and the
Durable Medical Equipment, Prosthetics, Orthotics and Supplies Fee
Schedule (DMEPOS)). In addition, we selected the updated period as the
12-month period ending June 30th of the year preceding the update year,
to maintain consistency with Medicare payment systems that are updated
on annual basis.
Comment: One commenter requested we establish a nominal fee to
cover the packaging and shipping of definitive drug testing collection
kits to and from patients who are being treated remotely.
Response: Section 1833(h)(3)(A) of the Act requires the specimen
collection fee to cover the appropriate costs of collecting the sample
on which a CDLT is performed. The statute does not specify the
establishment of a fee to cover packaging and shipping of definitive
drug testing collection kits to and from patients who are being treated
remotely.
Comment: Several commenters requested that the HCPCS codes and
nominal fees established for COVID-19 testing specimen collection in
the ``Medicare and Medicaid Programs; Policy and Regulatory Revisions
in Response to the COVID-19 Public Health Emergency'' IFC (85 FR
19230), should be maintained past the end of the PHE because: expenses
associated with specimen collection during the PHE (for example,
increased use of PPE due to more stringent infection control
requirements) have become permanent; COVID-19 and variants will
continue to circulate in congregate living facilities such as SNFs and
assisted living facilities for the elderly and in the community; the
need for diagnostic and screening tests for COVID-19 will not terminate
automatically when the PHE is terminated; the duration of a COVID-19
vaccine's protective immunity is not known; and after the end of the
PHE, the risks to those collecting specimens for COVID-19 testing will
remain, as will the costs associated with mitigating those risks (for
example, PPE and testing for specimen collectors themselves).
Response: We appreciate commenters' recommendations on continuing
the increased specimen collection fees in place for COVID-19 testing
beyond the PHE. We recognize that the PHE may have changed the specimen
collection landscape in that some COVID-19 protocols have become the
standard for the types of resources utilized and supplies needed for
other types of specimen collection. We have indicated that the
increased specimen collection fees during the PHE will end with the end
of the COVID-19 PHE (85 FR 19256; 86 FR 39309; 86 FR 65327).
Comment: One commenter requested that we remove the proposal to
only pay for specimens collected by ``trained technicians.'' The
commenter asserted that the ``trained technician'' title is vague and
does not properly distinguish between laboratory technicians with
varying degrees of education and experience. Furthermore, the commenter
expressed concern that the term ``trained technicians'' did not include
phlebotomists, and therefore, would seemingly disincentivize the
[[Page 69751]]
employment of phlebotomists, create issues in workforce demand, and
result in higher costs in acquiring personnel who were sufficiently
qualified.
Response: As previously noted, section 1833(h)(3) of the Act refers
to staff providing specimen collection services as ``trained
personnel,'' whereas the Medicare Claims Processing Manual, chapter 16,
section 60.2, refers to ``the technician.'' The BLS defines clinical
laboratory technologists and technicians as workers who collect samples
and also perform tests to analyze body fluids, tissue, and other
substances, and it defines a phlebotomist as a professional who draws
blood for tests, transfusions, research, or blood donations. The term
``laboratory technician'' may not apply to those staff that would
generally be providing specimen collection services, as the staff
collecting specimens may not also be involved in analyzing the
specimens. Therefore, for the purposes of our Medicare payment policies
for specimen collection and travel allowance, we proposed to use the
phrase ``trained technician'' to refer to those staff providing
specimen collection services. In our proposal, we noted that we
believed this clarification would more closely align the regulatory
text pertaining to specimen collection and travel allowance with the
statute. We note that the term ``trained technician'' does not mandate
certain educational requirements and, for the purposes of the specimen
collection provisions, the term includes a phlebotomist. Therefore, we
do not believe using the term trained technician will disincentivize
laboratories from employing phlebotomists. In fact, in the proposed
rule where we discussed our proposed codification and modifications of
the CLFS specimen collection travel allowance policy, we indicated that
we believed the BLS definition of phlebotomist more closely aligns with
the trained technicians that we believed are providing the types of
specimen collection services for which CMS provides a specimen
collection fee. Therefore, we proposed that a component of the travel
allowance mileage rate--the amount to cover expenses for a trained
technician--would be based on the most recent median hourly wage for
phlebotomists, as published in the BLS.
After consideration of comments and further analysis, we are
finalizing our specimen collection fee policies at Sec. 414.523(a)(1)
with certain modifications. Beginning January 1, 2023, CMS will pay a
general specimen collection fee of $8.57 for all specimens collected in
one patient encounter. This fee will be increased by $2 ($10.57) for
specimen collection from a Medicare beneficiary in a SNF or on behalf
of an HHA for all specimens collected in one patient encounter.
Additionally, we are finalizing that beginning January 1, 2024, we will
update the specimen collection fee amount for each CY by the percent
change in the CPI-U for the 12-month period ending June 30th of the
year preceding the update year. We will issue these updates to the
specimen collection fee amounts through subregulatory guidance,
specifically the existing CMS change request process, on an annual
basis. To be eligible for a specimen collection fee, the specimen must
be: used to perform a CDLT paid under the CLFS regulations at 42 CFR
part 414, subpart G; collected by a trained technician from a Medicare
beneficiary who is homebound, as described in Sec. 424.22(a)(1)(ii),
or is a non-hospital inpatient, but only when no qualified personnel
are available at the facility to collect the specimen; and of the
following type--a blood specimen collected through venipuncture or a
urine sample collected by catheterization.
d. Background on the Laboratory Specimen Collection Travel Allowance
Policy
Section 1833(h)(3)(B) of the Act requires the Secretary to provide
for and establish a fee to cover the transportation and personnel
expenses for trained personnel to travel to the location of an
individual to collect the sample on which a CDLT was performed, except
that such a fee may be provided only to an individual who is homebound
or an inpatient in an inpatient facility (other than a hospital). Like
the laboratory specimen collection fee policy discussed previously, our
longstanding policies and instructions regarding the statutory
requirements for the CLFS specimen collection travel allowance are
described in the Medicare Claims Processing Manual guidance and CRs,
currently with no corresponding regulations text. In an August 18, 1993
proposed rule titled ``Medicare and Medicaid: Programs; Payment for
Clinical Diagnostic Laboratory Tests,'' we proposed to reflect both the
CLFS specimen collection and travel allowance payment policies in
regulation (58 FR 43838), however, the proposals therein were not
finalized.
As discussed in that proposed rule, due to the variability in time,
distance, and wage circumstances in different localities, we
implemented the travel allowance under section 1833(h)(3)(B) of the Act
by allowing the MACs discretion in calculating travel allowances. We
provided general guidance through our manuals, specifically in the
Medicare Claims Processing Manual, chapter 16, section 60.2.\171\
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\171\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c16.pdf.
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The Medicare Claims Processing Manual guidance at chapter 16,
section 60.2 describes two methods for calculating and billing travel
allowance for specimen collection. HCPCS code P9603 is used when the
average round trip to a beneficiary's home or nursing home is farther
than 20 miles, paid on a mileage per trip basis. HCPCS code P9604 is
used when the average round trip is less than or equal to 20 miles,
paid on a flat rate per trip basis. The manual further states that the
travel allowance is intended to cover the estimated travel costs for a
laboratory technician to travel to collect the specimen and to reflect
the technician's salary and travel costs. The travel allowance can be
made only where a specimen collection fee is also payable; that is, no
travel allowance is made where the technician merely performs a
messenger service to pick up a specimen drawn by a physician or nursing
home personnel. The manual also states that the travel allowance may
not be paid to a physician unless the trip to the beneficiary's home,
or to the nursing home where the beneficiary resides, was solely for
the purpose of drawing a specimen. Otherwise, the travel costs are
considered to be associated with the other purposes of the trip.
Furthermore, the manual states that the travel allowance is not
distributed by CMS. Instead, the MACs (that is, within the claims
processing system) calculate the travel allowance for each claim using
the rules for the HCPCS codes used for travel allowances, which are
P9603--Per Mile Travel Allowance and P9604--Flat Rate.
As described in the manual, the conditions for usage of HCPCS code
P9603 are that the minimum ``per mile travel allowance'' is $1.04
(based on CY 2022 instructions). The per mile travel allowance is to be
used in situations where the average trip to beneficiaries' homes is
farther than 20 miles, and is to be prorated in situations where
specimens are drawn or picked up from non-Medicare patients in the same
trip.
The manual further states that the per mile allowance is computed
using the Federal mileage rate (as determined by the Internal Revenue
Service (IRS)), plus an additional 45 cents a mile to cover the
technician's time and travel costs.
[[Page 69752]]
For 2022, the Federal mileage rate is 58.5 cents; \172\ that amount
plus 45 cents equals $1.035, rounded up to $1.04. The manual currently
indicates that contractors have the option of establishing a higher per
mile rate in excess of the minimum ($1.04 a mile in CY 2022) if local
conditions warrant it. The manual also states that the minimum mileage
rate will be reviewed and updated in conjunction with the CLFS as
needed, and that at no time will the laboratory be allowed to bill for
more miles than are reasonable or for miles not actually traveled by
the laboratory technician.\173\
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\172\ https://www.irs.gov/newsroom/irs-issues-standard-mileage-rates-for-2022.
\173\ The Medicare Claims Processing Manual is available on the
CMS website at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c16.pdf. The manual provides
examples of the per-mile travel allowance in section 60.2--Travel
Allowance.
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For the flat-rate HCPCS code, P9604, the manual provides the
following conditions of usage: CMS will pay a minimum of $10.40 for the
flat rate code (HCPCS code P9604, based on CY 2022 instructions), which
is the one-way flat rate travel allowance. The flat rate travel
allowance is to be used in areas where average trips are less than 20
miles. The flat rate travel allowance is to be prorated for more than
one blood draw at the same address, and for stops at the homes of
Medicare beneficiaries and non-Medicare patients. The laboratory
performs the proration calculation when the claim is submitted based on
the number of beneficiaries seen on that trip, and the specimen
collection fee will be paid for each beneficiary encounter.
The manual states that this rate is based on the assumption that a
trip is an average of 15 minutes and up to 10 miles one way and uses
the Federal mileage rate (as determined by the IRS) and a laboratory
technician's time of $17.66 an hour, including overhead. The manual
states that contractors have the option of establishing a flat rate in
excess of the minimum of $10.00, if local conditions warrant it, and
that the minimum national flat rate will be reviewed and updated in
conjunction with the CLFS, as necessitated by adjustments in the
Federal travel allowance and salaries. The manual provides examples of
the flat rate calculation and describes further MAC flexibilities
regarding payment for the CLFS specimen collection travel allowance.
The manual also indicates that MACs may use their discretion for the
payment of travel allowance in circumstances where the CDLTs are needed
on an emergency basis outside the general business hours of the
laboratory making the collection. The manual also states that updates
to the travel allowance amounts will be issued by CMS via Recurring
Update Notification (RUN) on an annual basis.
In summary, the Medicare Claims Processing Manual, chapter 16,
section 60.2, indicates that HCPCS code P9603 is used when the average
round trip to a beneficiary's home or nursing home is farther than 20
miles, paid on a mileage per trip basis. HCPCS code P9604 is used when
the average round trip is less than or equal to 20 miles, paid on a
flat rate per trip basis. In instances where one trip is made in order
to execute specimen draws or pickups from multiple patients, the travel
payment component is prorated based on the number of Medicare
beneficiaries and non-Medicare patients (not the number of specimens
collected) on that trip. All instances of specimen collection and
pickups are included in the proration, and the prorated specimen
collection travel allowance is billed on behalf of each Medicare
patient.
Furthermore, we have provided additional payment instructions
through RUN CLFS--Medicare Travel Allowance Fees for Collection of
Specimens CRs; the latest being CR 12593,\174\ which was issued on
January 14, 2022. Consistent with the manual, CR 12593 states that the
travel allowance HCPCS codes allow for payment either on a per-mileage
basis (P9603) or on a flat-rate per-trip basis (P9604). The CR states
that under either method, when one trip is made for multiple specimen
collections (for example, at a nursing home), the travel payment
component is prorated based on the number of specimens collected on
that trip, for both Medicare and non-Medicare patients, either at the
time the claim is submitted by the laboratory or when the flat rate is
set by the contractor.
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\174\ https://www.cms.gov/files/document/r11184cp.pdf.
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CR 12593 states that the Per Mile Travel Allowance (P9603) is to be
used in situations where the average trip to the patients' homes is
longer than 20 miles round trip and is to be prorated in situations
where specimens are drawn from non-Medicare patients in the same trip.
For CY 2022, the allowance per mile was computed using the Federal
mileage rate of $0.585 per mile plus an additional $0.45 per mile to
cover the technician's time and travel costs. The IRS determines the
standard mileage rate for businesses based on periodic studies of the
fixed and variable costs of operating an automobile, and CMS utilizes
this amount for P9604. The CR also states that the Per Flat-Rate Trip
Basis Travel Allowance (P9604) is a set fee amount, which is $10.40 for
CY 2022.
In summary, CR 12593 states that the travel payment component is
prorated based on the number of specimens collected on the trip (and
not the number of Medicare and non-Medicare patients), for both
Medicare and non-Medicare patients, which differs from the manual
instruction which states that the travel allowance should be prorated
based on the number of Medicare beneficiaries and non-Medicare patients
(not the number of specimens collected) on that trip.
e. Policy Concerns and Recommendations on the CLFS Specimen Collection
Travel Allowance
Laboratories, members of the laboratory industry, and other
interested parties have expressed concerns regarding our current CLFS
travel allowance payment policy, suggesting that the travel proration
methodology is unclear and that guidance in the Medicare Claims
Processing Manual, payment CRs and guidance provided by the MACs are
conflicting. Additionally, members of the public have asserted that the
travel allowance requirements are administratively complex.
In the CY 2022 PFS proposed rule (86 FR 39310), we requested broad
comments on our policies for specimen collection fees and the travel
allowance for consideration for possible updates to policies in the
future through notice and comment rulemaking. As discussed in the CY
2022 PFS final rule (86 FR 65328), commenters supported clarification
to the existing travel allowance policy and also made suggestions
regarding possible refinements.
Several commenters described their concerns regarding the current
travel allowance policy, stating that the current system requires the
individual tracking of miles and paperwork documenting those miles, as
well as the calculation of billable charges. Commenters stated that
this system creates inconsistencies across facilities providing
specimen collection services and creates confusion and burden for
health care providers and MACs. One commenter also noted that because
of the complex logistics involved in obtaining specimens from homebound
patients and non-hospital inpatients and transporting the specimens for
prompt processing, a disincentive is created for serving this
potentially underserved patient population, leading to potential access
issues for Medicare beneficiaries.
[[Page 69753]]
Several commenters requested that CMS simplify the travel allowance
by creating a single per-encounter flat-rate payment for travel, which
would simplify personnel and transportation expenses by eliminating the
individual tracking of miles and paper documenting of those miles as
well as the calculation of billable charges. The commenters stated that
a flat-rate approach would also provide greater consistency across
facilities served and reduce the burden on health care providers and
MACs, and therefore, further support continued patient access to these
laboratory services. A few commenters suggested the creation of a rural
add-on payment to provide payment to those laboratories serving
Medicare beneficiaries residing in remote areas. Several commenters
also stated that the current travel allowance is prone to billing
inconsistencies, so simplifying the calculation of the travel allowance
would increase the overall understanding of the policy among impacted
parties, decrease the instances of health care providers inadvertently
overbilling for mileage, reduce program integrity concerns, and improve
clarity for all parties involved.
Several commenters also recommended that business requirements
outlined in the annual Medicare travel allowance CR be updated to
require the contractor to search their files to adjust claims already
paid at the prior year travel allowance rather than require action by
laboratories. The commenter requested that contractors be instructed to
review claims and reprocess at the updated rates rather than require
laboratories to initiate the revisions.
Additionally, the OIG issued an August 25, 2021 report, CMS Needs
To Issue Regulations Related to Phlebotomy Travel Allowances (A-06-20-
04000),\175\ in which the OIG discussed ongoing concerns regarding the
Medicare CLFS travel allowance policy and summarized findings from
previous audits of MACs in which claims for phlebotomy travel
allowances were paid using incorrect prorated mileage and claims for
phlebotomy travel allowances were paid using incorrect payment rates.
The OIG also described instances in which health care provider
documentation was insufficient to warrant payment of the phlebotomy
travel allowances.
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\175\ https://oig.hhs.gov/oas/reports/region6/62004000.asp.
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The 2021 OIG report presented recommendations to CMS regarding the
CLFS travel allowance policy, including working with the MACs to
educate health care providers about the documentation requirements for
specimen collection travel allowances, instructing the MACs to identify
and adjust any paid claims that incorrectly used the previous year's
rate, and issuing regulations related to phlebotomy travel to clarify
various aspects of the travel allowance payment policy.
In the CY 2022 PFS proposed rule (86 FR 39310 through 39311) and CY
2022 PFS final rule (86 FR 65328), we discussed the travel allowance
policy and stated that we made permanent the option for laboratories to
maintain electronic documentation of miles traveled for the purposes of
covering the transportation and personnel expenses for trained
personnel to travel to the location of an individual to collect a
specimen sample. This option for laboratories to maintain electronic
documentation applies to specimen collection for any CDLT. We noted
that laboratories will need to be able to produce electronic
documentation in a form and manner that can be shared with MACs, and
should continue to consult with their local MACs regarding the format
and process for submission of this information if necessary. We stated
that we believed this flexibility to maintain electronic documentation
of miles traveled provides clarity to laboratories about documentation
requirements for the Medicare CLFS travel allowance for specimen
collection payment policy.
Additionally, we have instructed the MACs to identify and adjust
any paid claims that incorrectly used the previous year's rate, thereby
addressing the OIG's and commenters' suggestions regarding reprocessing
using the updated rates through the revision of business requirements
in the January 14, 2022 RUN CLFS--Medicare Travel Allowance Fees for
Collection of Specimens CR 12593.\176\ The OIG and commenters alike
recommended that we update the business requirements outlined in the
annual Medicare travel allowance CR to require the MACs to search their
files to adjust claims already paid at the prior year's travel
allowance amount rather than require action by laboratories.
Specifically, in the CR, we included the Business Requirement 12593.5,
which states that ``Contractors shall adjust previously paid travel
allowance claims with dates of service on or after January 1, 2022, in
order to apply the updated payment rate and initiate those adjustments
within 60 days, if claims are paid at the prior year's rates before the
new rate is entered into the MACs' systems.'' We stated that we
believed this modification to the business requirements will eliminate
the need for action by laboratories for adjustments to claims and
instead provide instruction to contractors to review claims and
reprocess at the updated rates as appropriate.
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\176\ https://www.cms.gov/files/document/r11184cp.pdf.
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f. Codification and Modifications of the CLFS Specimen Collection
Travel Allowance Policy
As described in detail in the CY 2023 PFS proposed rule (87 FR
46070 through 46081), in light of the concerns from the public, and in
an effort to respond to the OIG's recommendation that CMS issue
regulations regarding certain aspects of the travel allowance for
specimen collection payment policy, we proposed to codify in our
regulations, and make certain modifications and clarifications to, the
Medicare CLFS travel allowance policies. As discussed in the proposed
rule, we believed the proposals would achieve CMS' aims of simplifying
and clarifying our travel allowance policies. We proposed to add Sec.
414.523(a)(2), ``Payment for travel allowance,'' to reflect the
requirements for the travel allowance for specimen collection.
Specifically, in accordance with section 1833(h)(3)(B) of the Act, we
proposed to include in our regulations the following: (1) general
requirement; (2) travel allowance basis; and (3) travel allowance
amount.
Section 1833(h)(3)(B) of the Act states that the Secretary shall
provide for and establish a fee to cover the transportation and
personnel expenses for trained personnel to travel to the location of
an individual to collect the sample. We noted in the proposed rule that
we believe this language indicates that only instances of specimen
collection requiring trained technicians \177\ for the purposes of
collecting the sample are to be included in the travel allowance
calculation. Therefore, travel for simple pickup of specimens or for
specimen collection that does not require the services of trained
technicians should not be considered in the calculation of the travel
allowance. This means, the travel allowance may be paid only if a
specimen collection fee is also payable; for example, no travel
allowance would be paid if a trained technician merely performs a
messenger service to pick up a specimen drawn by other technicians.
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\177\ As noted previously in this section of the proposed rule,
we are proposing to use the term ``trained technician'' for purposes
of our specimen collection fee and travel allowance policies.
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[[Page 69754]]
The Medicare Claims Processing Manual, chapter 16, section 60.2
states, ``The additional allowance can be made only where a specimen
collection fee is also payable, that is, no travel allowance is made
where the technician merely performs a messenger service to pick up a
specimen drawn by a physician or nursing home personnel.'' We proposed
to codify this general requirement at Sec. 414.523(a)(2)(i),
indicating that the provision would state that CMS pays a travel
allowance where the specimen is one for which a specimen collection fee
is paid and would make clear that all of the requirements for the
specimen collection fee to be paid (which are specified in Sec.
414.523(a)(1)) would need to be met for the travel allowance to be
payable.
Additionally, section 1833(h)(3)(B) of the Act states that the
travel allowance may be provided only with respect to an individual who
is homebound or an inpatient in an inpatient facility (other than a
hospital). We explained that we interpreted this statutory language to
mean that the fee only applies when a trained technician draws a
specimen from a patient who either is in an inpatient facility that is
not a hospital or is a homebound patient. (A discussion regarding the
definition of a homebound patient is provided in section III.B.6.b. of
the proposed rule and III.C.6.b of this final rule.) The Medicare
Claims Processing Manual, chapter 16, section 60.2 states that
``Medicare, under Part B, covers a specimen collection fee and travel
allowance for a laboratory technician to draw a specimen from either a
nursing home patient or homebound patient.'' We noted that we believed
it is appropriate to codify that the travel allowance is permitted only
where the individual from whom the specimen is collected is homebound
or is an inpatient in an inpatient facility (other than a hospital). We
proposed to codify this requirement at Sec. 414.523(a)(2), which as we
noted would therefore require all of the specimen collection fee
requirements at Sec. 414.523(a)(1) to be met, and which would include
the proposed requirement at Sec. 414.523(a)(1)(ii) that the specimen
is collected from a Medicare beneficiary who is homebound as described
in Sec. 424.22(a)(1)(ii) or a non-hospital inpatient.
In Sec. 414.523(a)(2)(ii), we proposed to codify and clarify that
CMS pays a travel allowance on the following bases: (A) flat-rate
travel allowance; and (B) per-mile travel allowance. We explained that
we interpreted the statutory language in section 1833(h)(3)(B) of the
Act that requires us to pay a fee for trained personnel to travel to
the location of an individual to collect the sample to mean that the
travel allowance fee is only applicable to travel that is for the
purpose of collecting the specimen from a Medicare beneficiary. To that
end, we noted that we believed only one travel allowance payment may be
made for specimen collection for a Medicare beneficiary based on the
beneficiary's location, and only when a Medicare beneficiary requires
the collection of a specimen necessary for performance of CDLTs. We
also noted that we believed that non-Medicare patients should not be
included in any portion of the calculation of the travel allowance.
This interpretation would be a modification to existing guidance in the
Medicare Claims Processing Manual, chapter 16, section 60.2, which
states that the travel allowance ``is to be pro-rated in situations
where specimens are drawn or picked up from non-Medicare patients in
the same trip.'' As explained in the proposed rule, this modification
would reflect our position that only Medicare patients should be
considered in the calculation and payment of the travel allowance,
which would more closely align with the statutory language regarding
``the location of an individual,'' that is, the location of a Medicare
beneficiary receiving specimen collection services. We also noted that
we believed this modification would address concerns from laboratories,
the OIG, and other interested parties who requested clarification
regarding the inclusion of Medicare and non-Medicare beneficiaries in
the travel allocation calculation.
We proposed that, whether a laboratory bills the flat-rate travel
allowance basis or the per-mile travel allowance basis would depend
upon the total miles traveled and number of locations. Section
1833(h)(3)(B) of the Act states, in establishing a fee to cover the
transportation and personnel expenses for trained personnel to travel
to the location of an individual to collect a sample, the Secretary
shall provide a method for computing the fee based on the number of
miles traveled and the personnel costs associated with the collection
of each individual sample. Therefore, we noted that we believed a key
component of the travel allowance payment for specimen collection is
the number of miles traveled for the specimen collection.
In considering potential methodologies for calculating a travel
allowance for specimen collection, we discussed in the proposed rule
that we conducted an analysis of the usage of the existing Per Mile
Travel Allowance HCPCS code (P9603) to understand the usage of P9603
and analyze the billing of miles related to travel allowance for
specimen collection. In CY 2019, among professional and institutional
Medicare claims, there were approximately 3.2 million total claim lines
billed for HCPCS code P9603 (per-mile travel allowance). Among the
P9603 claim lines, the average mileage billed per claim line was 18.8
with a standard deviation of 33.4. However, the median distance
traveled per line was 7 miles. Of all P9603 claim lines, 76.3 percent
were billed with less than 20 miles, and 37.9 percent of all P9603
claim lines were billed with less than five miles. The average payment
per line for P9603 in CY 2019 was $18.13; however, the median payment
per line was $6.09. Additionally, our analysis also showed that 23.7
percent of miles traveled were greater than 20 miles, with 150,442
claim lines of the approximately 3.2 million total claim lines, or 4.7
percent, logging more than 85 miles per trip. As discussed in the
proposed rule, we believed that these long-distance trips likely
reflect specimen collection from beneficiaries in rural areas (which
are generally underserved zones). Given that the majority of P9603
claim lines (76.3 percent) are billed with less than 20 miles, we also
noted that we believed that 20 miles would be an appropriate threshold
for use in the travel allowance bases for specimen collection. In
addition, to address concerns about administrative complexity, we
proposed that the flat-rate travel allowance basis only would be
available for trips involving one location.
Specifically, we proposed in Sec. 414.523(a)(2)(ii)(A) that the
flat-rate travel allowance basis would apply when the trained
technician travels 20 eligible miles or less to and from one location
for specimen collection from one or more Medicare beneficiaries. We
stated that we believed that section 1833(h)(3) of the Act supports
payment for specimen collection and travel allowance for only Medicare
beneficiaries and should not include non-Medicare beneficiaries. As
proposed, laboratories would bill Medicare using existing HCPCS code
P9604 to receive payment for the flat-rate travel allowance amount,
prorated by the number of beneficiaries for whom a specimen collection
fee is paid. As discussed in the proposed rule, we believed that
providing payment for the proposed flat-rate travel allowance basis
would serve to simplify the administrative requirements for
laboratories in terms of billing and
[[Page 69755]]
record-keeping activities. Additionally, we discussed in the proposed
rule that the clarification regarding requirements for proration would
address issues raised by interested parties, including the OIG, who
expressed concerns regarding inconsistencies in current guidance. We
sought comment on considerations related to the flat-rate travel
allowance basis, including considerations for proposed distance,
alternatives for a possible flat-rate travel allowance basis, as well
as the utility of this basis or the potential exclusion of this basis
for the purposes of the travel allowance for specimen collection.
In addition to the flat-rate travel allowance basis, we proposed in
Sec. 414.523(a)(2)(ii)(B) the per-mile travel allowance basis, which
we explained would apply when the trained technician travels more than
20 eligible miles to and from one location for specimen collection from
one or more beneficiaries or when the trained technician travels to
more than one location for specimen collection from more than one
Medicare beneficiary. We clarified that this proposed basis would apply
in two circumstances--where round-trip travel to one location is
greater than 20 eligible miles and where travel is to more than one
location, regardless of the number of miles traveled. We proposed to
modify the per-mile travel allowance policy in this way for greater
clarity, administrative simplification, and consistency with statute.
As proposed, the laboratory would receive payment under the per-mile
travel allowance basis for the total number of miles traveled for
specimen collection, which would be allocated to each Medicare
beneficiary for whom a specimen collection fee is paid. We discussed
that we believed the proposal would serve to address the OIG's
recommendations that CMS clarify various aspects of the travel
allowance payment policy, including requirements for proration, which
we discussed more fully in the travel allowance amount calculation
proposal in the proposed rule. We sought comment on all aspects of the
proposed per-mile travel allowance basis.
Additionally, we proposed to specify travel allowance amount
requirements pertaining to eligible miles, the travel allowance mileage
rate, and the travel allowance amount calculation at Sec.
414.523(a)(2)(iii). At Sec. 414.523(a)(2)(iii)(A), we proposed that
eligible miles would begin at the laboratory and end at the laboratory
where the trained technician returns the specimen(s) for testing. We
noted that we believed the laboratory is the most likely place where
the trained technician would become aware of the laboratory order and
acquire the necessary supplies to perform the specimen collection. We
explained that although we do not believe the trained technician would
commence travel related to specimen collection from a location other
than the laboratory, we sought comment as to whether there are
alternative starting locations we should consider. We noted that the
provision requiring that the mileage calculation begins at a
laboratory, as proposed, would codify existing policy in the Medicare
Claims Processing Manual, chapter 16, section 60.2, which provides
several examples of travel allowance scenarios that reference the start
of a travel allowance route as beginning at a laboratory, and would be
consistent with section 1833(h)(3)(B) of the Act.
We further proposed in Sec. 414.523(a)(2)(iii)(A) that eligible
miles would not include miles traveled for any purpose unrelated to
specimen collection, such as collecting specimens from non-Medicare
beneficiaries or for personal reasons. We noted that we believed the
statutory language in section 1833(h)(3)(B) of the Act supported the
proposal to exclude from the calculation of eligible miles any miles
traveled to a location where no specimens are collected, to the
location of a non-Medicare beneficiary for specimen collection, to a
Medicare beneficiary where no specimen collection occurs, or for
personal purposes. We explained that the proposed provision would
codify the Medicare Claims Processing Manual, chapter 16, section 60.2,
which states that ``the travel allowance is intended to cover the
estimated travel costs of collecting a specimen.''
In Sec. 414.523(a)(2)(iii)(B), we proposed to set forth the travel
allowance mileage rate, to be used in the travel allowance amount
calculations. Section 1833(h)(3)(B) of the Act requires the travel
allowance to cover both the ``transportation'' and ``personnel
expenses'' for trained personnel to travel to the location of an
individual to collect a sample. As proposed, the travel allowance
mileage rate would reflect both of these components.
As described in the proposed rule, we issue annual travel allowance
amounts through CR publications, such as CR 12593.\178\ Currently, CMS
adds the IRS standard mileage rate to an additional $0.45 per mile,
which is intended to pay for the trained personnel's time, as described
in CR 12593, where the additional $0.45 per mile addresses time and
travel costs required by the technician for approximately 15 minutes of
labor. The manual states that this rate is based on the assumption that
a trip is an average of 15 minutes and up to 10 miles one way and uses
the Federal mileage rate (as determined by the IRS) and a technician's
time of $17.66 an hour, including overhead. For CY 2022, the IRS
standard mileage rate is $0.585. That amount plus $0.45 for the trained
personnel's labor yields a travel allowance mileage rate of $1.035,
which is rounded up to $1.04 for CY 2022. We proposed to codify the
travel allowance mileage rate in regulation, as well as modify and
clarify certain aspects of it.
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\178\ https://www.cms.gov/files/document/r11184cp.pdf.
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The IRS updates and issues standard mileage rates on a periodic
basis, generally annually.\179\ These rates are used to calculate the
deductible costs of operating an automobile for business, charitable,
medical, or moving for the purpose of calculating Federal taxes. We
proposed that the ``transportation'' component of the travel allowance
mileage rate would equal the IRS standard mileage rate, which would be
consistent with our current policy. We noted that we believed using the
IRS standard mileage rate would continue to be an appropriate way to
cover transportation as the IRS rate accounts for the costs associated
with transportation per mile traveled. We sought comment on the
proposal to use the IRS standard mileage rate to cover the
transportation component of the travel allowance mileage rate.
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\179\ https://www.irs.gov/newsroom/irs-issues-standard-mileage-rates-for-2022.
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In addition, we proposed to include an amount to cover the
``personnel expenses'' component of the travel allowance mileage rate
where the trained technician's personnel expenses would be based on a
wages-per-mile amount. First, we proposed that personnel expenses are
wages in this context, where wages would represent the cost of the
trained technician's time for traveling to collect the sample. We also
proposed to base the specific wage amount on data from the BLS, which
publishes salary statistics for occupations in the United States. The
BLS defines a phlebotomist as a professional who draws blood for tests,
transfusions, research, or blood donations.\180\ The BLS separately
defines clinical laboratory technologists and technicians as workers
who collect samples and perform tests to analyze body fluids, tissue,
and other
[[Page 69756]]
substances.\181\ For purposes of the travel allowance, we stated that
we believed the BLS definition of phlebotomist more closely aligns with
the trained technicians that we believed are providing the types of
specimen collection services described earlier in this section, as a
phlebotomist typically draws blood or other specimens, while a
laboratory technologist may both collect the specimen as well as
analyze the specimen. We noted that we did not believe that trained
technicians collecting the specimen for the purposes of our specimen
collection policies are also analyzing the specimens. Therefore, we
proposed to use wage data in the BLS-defined category of phlebotomist
to establish the personnel expense component of the travel allowance
mileage rate.
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\180\ https://www.bls.gov/ooh/healthcare/phlebotomists.htm.
\181\ https://www.bls.gov/ooh/healthcare/clinical-laboratory-technologists-and-technicians.htm.
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For CY 2021 (the latest available information), the BLS states that
the median pay (or the wage at which half of the workers in the
occupation earned more than that amount and half earned less) for
phlebotomists is $17.97 per hour.\182\ To account for the personnel
expenses associated with travel for specimen collection, we proposed to
use the latest available published figure for the median hourly wage
amount for phlebotomists, which is published by the BLS, for the
purposes of annually updating the travel allowance amount for specimen
collection. We proposed to codify this aspect of the travel allowance
mileage rate at Sec. 414.523(a)(2)(iii)(B) by describing that the
travel allowance mileage rate includes an amount to cover expenses for
a trained technician equal to the most recent median hourly rate for
phlebotomists, as published by the BLS. As discussed in the proposed
rule, this approach would be a clarification of and modification to
current guidance, as CR 12593 describes that the $0.45 per mile added
to the IRS rate is meant to address the trained personnel's time and
travel costs based on approximately 15 minutes of labor.
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\182\ https://www.bls.gov/ooh/healthcare/phlebotomists.htm.
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Next, we discussed that we would calculate a per-mile amount to
derive the approximate number of miles traveled by the trained
technician each hour. To do so, we proposed to use an average driving
speed. The average miles-per-hour driving speed would be multiplied by
the trained technician's estimated wages, as described above, and the
result would be an amount that represents wages per mile, which would
be the personnel expenses associated with travel for specimen
collection. We proposed to use an average driving speed of 40 miles per
hour, as we believed most of the travel related to specimen collection
would be performed in local and residential areas, as our data show
that the median number of miles traveled for specimen collection is
approximately 7 miles.
Therefore, to establish the personnel expenses component of the
travel allowance mileage rate, which would be a per-mile amount, we
proposed that we would divide the most recent median hourly wage for
phlebotomists, as published by the BLS, by 40 to represent an average
miles-per-hour. We proposed to codify this aspect of the travel
allowance mileage rate at Sec. 414.523(a)(2)(iii)(B). For CY 2023, the
amount would be equal to the most recent BLS median hourly wage for a
phlebotomist of $17.97 per hour (which is currently the BLS CY 2021
rate) divided by 40, which is $0.45 per mile. We noted that this amount
is consistent with the amount that we add to the IRS rate under our
current travel allowance policy.
In summary, we proposed to establish in Sec. 414.523(a)(2)(iii)(B)
that the travel allowance mileage rate is equal to the IRS standard
mileage rate plus an amount to cover expenses for a trained technician
equal to the most recent median hourly wage for phlebotomists, as
published by the BLS, divided by 40 to represent an average miles-per-
hour driving speed. We indicated in the proposed rule that the travel
allowance mileage rate would be updated annually using the most recent
IRS and BLS information, which we would issue in subregulatory guidance
annually through CRs.
We sought comment on all aspects of the proposed travel allowance
mileage rate, including the use of the IRS standard mileage rate to
cover transportation, the proposed use of estimated wages and average
driving speed to cover personnel expenses, and other specific
considerations or alternatives for establishing the rate.
Finally, we proposed to include in Sec. 414.523(a)(2)(iii)(C) the
travel allowance amount calculations for the flat-rate travel allowance
basis and the per-mile travel allowance basis discussed previously in
this section of the final rule. We stated that we believed that these
proposed calculations would be a modification to existing guidance,
which we noted would clarify and revise the travel allowance amount
calculations in several respects.
As explained in the proposed rule, in our analysis of mileage
traveled for the purposes of specimen collection, described above, the
results indicate that the median mileage per trip for specimen
collection per Medicare beneficiary is approximately 7 miles;
therefore, we noted that we believed that a reasonable approximation of
the typical mileage required for specimen collection per beneficiary is
about 10 miles. As such, for the flat-rate travel allowance basis, we
proposed in Sec. 414.523(a)(2)(iii)(C)(1) that the travel allowance
amount calculation is the travel allowance mileage rate multiplied by
ten (10) (for CY 2023 example purposes, this amount would be $10.40)
and divided by the number of beneficiaries for whom a specimen
collection fee is paid. We explained that dividing by the number of
beneficiaries for whom a specimen collection fee is paid would ensure
that the flat-rate travel allowance amount is apportioned to each
beneficiary receiving specimen collection services and that payment is
calculated in an operationally feasible manner, as a laboratory must
submit a claim for each beneficiary to receive payment for travel
allowance; this would allow for a fixed payment amount to be
straightforwardly apportioned to the number of beneficiaries for whom a
specimen collection fee is paid in a single location. We noted that we
believed this proposed flat-rate travel allowance calculation would
simplify payment for travel to one location for specimen collection
services requiring travel of 20 miles or less, which would ease
administrative burden. Additionally, we stated, the proposed
methodology would be consistent with the existing flat-rate travel
allowance payment policy described in CR 12593 and would clarify the
proration methodology.
For an example of the proposed flat-rate travel allowance
calculation, consider a situation in which a trained technician travels
7 miles from the laboratory to a nursing home to collect blood
specimens collected through venipuncture from five patients, four of
whom are Medicare beneficiaries. The trained technician collects three
specimens from Medicare beneficiaries, collects one specimen from the
non-Medicare patient, and simply picks up a previously collected
specimen from one Medicare beneficiary. The trained technician then
drives 7 miles back to the laboratory to deliver the specimens without
making any other stops. The trained technician has provided specimen
collection services to three Medicare beneficiaries. One Medicare
beneficiary did not require specimen
[[Page 69757]]
collection services, and therefore, a specimen collection fee would not
be payable. In this example, the laboratory would use the flat-rate
travel allowance basis because the trained technician traveled a total
of 14 miles. To calculate the travel allowance mileage rate, the
laboratory would divide flat-rate travel allowance amount of $10.40 by
the number of beneficiaries for whom a specimen collection fee is paid
(three beneficiaries), which equals $3.47. To bill for the travel
allowance, the laboratory would submit one claim for each beneficiary
for whom a specimen collection fee is paid by billing HCPCS code P9604.
We proposed that updates to travel allowance mileage rates would be
issued through subregulatory guidance, specifically the existing CMS
change request process, on an annual basis. We sought comment on all
aspects of the proposed calculation of the flat-rate travel allowance
amount, including considerations for the proposed mileage factor of ten
(10) and the proposed proration by the number of beneficiaries for whom
a specimen collection fee is paid.
We also proposed to clarify, modify, and codify in regulation the
calculation for the per-mile travel allowance amount. Under proposed
Sec. 414.523(a)(2)(iii)(C)(2), the per-mile travel allowance amount
would equal the number of eligible miles multiplied by the travel
allowance mileage rate, divided by the number of beneficiaries for whom
a specimen collection fee is paid.
As discussed previously, we believe that section 1833(h)(3) of the
Act supports payment for specimen collection and travel allowance only
for Medicare beneficiaries, and we proposed that the per-mile travel
allowance amount calculation would only consider the number of Medicare
beneficiaries from whom specimens are collected in the proration of the
per-mile travel allowance. As the current policy in manual guidance and
the CR factor are inconsistent in referring to the number of specimens
or number of patients, we noted that the proposal would be a policy
change to clarify that only the number of Medicare beneficiaries for
whom a specimen collection fee is paid should be included in the
calculation.
We explained that, to calculate the per-mile travel allowance
amount, the laboratory would first calculate the total number of
eligible miles, as set forth in proposed Sec. 414.523(a)(2)(iii)(A),
the trained technician traveled--this would be the total number of
miles traveled by the trained technician to locations where one or more
Medicare beneficiaries received specimen collection services and back
to the laboratory where the technician returns the specimen(s) for
testing. The eligible miles would be multiplied by the travel allowance
mileage rate as set forth in proposed Sec. 414.523(a)(2)(iii)(B), then
divided by the number of beneficiaries for whom a specimen collection
fee is paid, which would yield a prorated travel allowance amount.
Under this approach, the laboratory would receive payment for the total
number of eligible miles traveled for specimen collection, apportioned
equally to each Medicare beneficiary for whom a specimen collection fee
is paid. The laboratory would then submit a claim billing HCPCS code
P9603 for payment of the per-mile travel allowance amount for each
beneficiary for whom a specimen collection fee is paid. We stated that
we believed this calculation for the per-mile travel allowance basis
would resolve concerns raised by the public about inconsistent
guidance.
For an example of the per-mile travel allowance amount calculation,
consider a trained technician traveling 45 miles from a laboratory in a
city to a rural SNF, collecting blood specimens through venipuncture
from 6 Medicare beneficiaries, and then driving 45 miles to return to
the laboratory. In this example, the laboratory would use the per-mile
travel allowance basis because the trained technician traveled more
than 20 eligible miles to one location for specimen collection. To
calculate the per-mile travel allowance amount, the laboratory would
sum the eligible miles traveled to the location of Medicare
beneficiaries receiving specimen collection services, which, in this
case is 45 miles from the laboratory to the SNF and 45 miles from the
SNF returning to the laboratory, for a total of 90 eligible miles. The
eligible miles would then be multiplied by the travel allowance mileage
rate of $1.04, yielding a total of $93.60. This total amount would then
be prorated by dividing by the number of Medicare beneficiaries for
whom a specimen collection fee is paid (6), yielding a per-beneficiary
amount of $15.60 ($93.60/6 = $15.60). To bill for the travel allowance,
the laboratory would submit one claim for each beneficiary in the
amount of $15.60 HCPCS code P9603.
In another example, a trained technician travels 40 miles from a
laboratory to the location of a Medicare beneficiary to collect a blood
specimen through venipuncture, then travels 10 miles to the location of
a non-Medicare patient to collect a blood specimen through
venipuncture, then travels 20 miles to the location of two Medicare
beneficiaries to collect urine specimens by catheterization, and then
travels 20 miles to return to the laboratory. In this example, the
laboratory would use the per-mile travel allowance basis because the
trained technician traveled to more than one location for specimen
collection. To calculate the per-mile travel allowance amount, the
laboratory would sum the eligible miles, which would include the miles
traveled from the laboratory to the locations of Medicare beneficiaries
to collect specimens plus the miles back to the laboratory for specimen
drop-off. Eligible miles would not include the 10 miles traveled to the
location of the non-Medicare patient to collect a specimen, but would
include the 40 miles traveled from the laboratory to the location of
the first Medicare beneficiary, the 20 miles to the location of the two
Medicare beneficiaries, and the return trip to the laboratory of 20
miles, for a total of 80 eligible miles. The eligible miles would then
be multiplied by the travel allowance mileage rate of $1.04, yielding a
total of $83.20. This total would then be prorated by dividing by three
(3) Medicare beneficiaries for whom a specimen collection fee is paid,
yielding an amount of $27.73. The laboratory would then submit a claim
using HCPCS code P9603 for travel allowance for each of the Medicare
beneficiaries in the amount of $27.73. Again, the laboratory would
receive payment for the eligible miles traveled by the trained
technician, apportioned equally to each Medicare beneficiary for whom a
specimen collection fee is paid.
We stated that the proposed travel allowance payment policies would
represent both modifications to and clarifications of the specimen
collection travel allowance payment methodologies currently described
in guidance. We noted that we believed the proposed changes and
clarifications, if finalized, would improve and simplify the
administration of the travel allowance payment policy. Laboratories
would use HCPCS code P9604 to bill for the flat-rate travel allowance
basis for shorter trips to one location, and HCPCS code P9603 to bill
for the per-mile travel allowance basis for longer trips to one
location and trips to multiple locations, which we believed would
ensure payment for specimen collection services based upon eligible
miles required for such travel and address concerns of interested
parties about the provision of specimen collection services for
individuals residing in remote locations.
We sought comment on all aspects of this travel allowance proposal,
[[Page 69758]]
including the proposed general requirement, the proposed provisions
regarding the flat-rate and the per-mile travel allowance bases and the
utility of having both approaches, the proposed provisions regarding
eligible miles and the travel allowance mileage rate, as well as
considerations for the methodologies to calculate the travel allowance
amounts. We also sought comments on possible alternative considerations
for the CLFS travel allowance, including suggestions based on private-
payor and/or other approaches for tracking mileage and paying for
travel allowance, including per-beneficiary per-encounter bases, or
other approaches for providing payment for travel for specimen
collection. We noted that our proposed regulations would not require
MACs to calculate travel allowance payments, nor would they reflect the
MAC flexibilities with respect to travel allowance payment that are
currently in guidance, such as their discretion to pay the travel
allowance in circumstances where CDLTs are needed on an emergency
basis; we sought comment on this issue as well.
We noted that we would make conforming changes to the Claims
Processing Manual, Chapter 16, section 60 to reflect the proposed
travel allowance policies, if finalized, including any changes or
clarifications. We also stated in the proposed rule that we would
remove sections of the manual containing policies that are no longer
applicable.
The following is a summary of the public comments received on the
proposed provisions related to the travel allowance for specimen
collection policies and our responses:
Comment: Many commenters expressed support for the proposals to
codify and clarify the CLFS travel allowance policies. Commenters
appreciated the clarifications regarding all aspects of the payment
policies related to the CLFS travel allowance, including the proposed
general requirements, travel allowance bases, travel allowance amount,
and travel allowance amount calculations. Several commenters
specifically supported the general requirements including the
requirement that travel allowance amount may be paid only when a
specimen collection fee is also paid.
Several commenters also expressed support for the proposed travel
allowance bases. Commenters supported the flat-rate travel allowance
basis as applying to travel to and from one location of 20 miles or
less (P9604), and likewise supported the per-mile travel allowance in
instances when the technician travels more than 20 miles to and from
one location for specimen collection from one or more Medicare
beneficiaries or the technician travels to more than one location for
specimen collection from more than one Medicare beneficiary (P9603).
One commenter appreciated that the travel allowance proposal would
reimburse for travel of longer distances on a per-mile basis, which the
commenter believed would help promote access to services in more remote
or rural areas. Some commenters noted that codification and
clarification of CLFS travel allowance policies would help promote
continued access to CDLT services.
Response: We believe that the modifications and clarifications to
the travel allowance payment policies will improve and simplify the
administration of the travel allowance payment policy. We appreciate
the commenters' support for the proposed travel allowances bases, and
we believe the descriptions of the two travel allowance bases will help
clarify which travel allowance basis laboratories should use, which
will increase the accuracy of billing the travel allowance for specimen
collection. We are finalizing as proposed the general requirement at
Sec. 414.523(a)(2)(i) and the travel allowance bases at Sec.
414.523(a)(2)(ii).
Comment: Several commenters supported the proposed description of
eligible miles, noting specific support for excluding miles traveled
for any purpose unrelated to specimen collection. However, several
commenters did not agree with the proposal that eligible miles would
begin and end at the laboratory, and suggested that eligible miles
could instead begin at the home of the trained technician or elsewhere
when the trained technician begins their shift at a location other than
the laboratory. Some commenters specified that some laboratories
strategically recruit technicians based on the location of their home
residence to efficiently staff technicians on routes closer to the
facilities and/or patients served to limit travel time and maximize the
number of patients served per day. Others also mentioned that
laboratories may ship specimen collection supplies to the technician or
locations closer to their residence for efficiency. Additionally,
several commenters noted that electronic ordering procedures may negate
the necessity for technicians to begin at the laboratory because orders
for laboratory services may now be conveyed electronically through an
electronic medical records system to the technician before they begin
their route, or the technician may receive the details of specific
laboratory orders on paper requisitions when the technician arrives at
the location of the Medicare beneficiary, like a SNF, thereby negating
the need for the technician to travel to the physical location of the
laboratory in order to obtain the order for laboratory services.
Commenters further stated that the end point could include the
laboratory itself but may also include parcel drop-off points, courier
sites, or other locations where the specimen is transferred to the next
entity.
Response: We agree with the commenters that a trained technician's
travel for specimen collection from Medicare beneficiaries may begin at
a location other than the technician's home and therefore we are
modifying our proposed description of eligible to miles to reflect that
eligible miles do not necessarily have to begin at the laboratory. We
will now specify that eligible miles begin at the laboratory or the
starting point of the technician's travel for specimen collection. We
believe that broadening the description of eligible miles this way will
provide flexibility for the types of locations that could serve as the
starting point for travel related to specimen collection.
Additionally, as described above, commenters noted that travel for
specimen collection could end at a location other than the laboratory
and asserted that technicians often deliver the collected specimens to
a drop-off location for courier or shipping services. Therefore, we are
also modifying our proposed description of eligible miles do not
necessarily have to end at the laboratory. We will now specify that
eligible miles end at the laboratory or the ending point of the
technician's travel for specimen collection. We believe that broadening
the description of eligible miles this way will provide flexibility for
the types of locations that could serve as the ending point for travel
related to specimen collection.
We reiterate that only those miles that are related to the
technician's travel for specimen collection from a Medicare beneficiary
will meet the requirements eligible miles for the purposes of the
travel allowance. Miles that are not related to specimen collection, as
described above, may not be included as eligible miles for the purposes
of Medicare payment for travel allowance for specimen collection. As we
discuss above, this aspect of the policy will also be codified in
regulation at Sec. 414.523(a)(2)(iii)(A), where we describe that
eligible miles do not include miles traveled for any purpose unrelated
to specimen collection, such as collecting specimens from non-Medicare
beneficiaries or for personal reasons.
[[Page 69759]]
In summary, we are revising the description of eligible miles at
Sec. 414.523(a)(2)(iii)(A) such that eligible miles begin at the
laboratory or the starting point of the technician's travel for
specimen collection and end at the laboratory or the ending point of
the technician's travel for specimen collection.
Furthermore, as described in section III.C.6.e. of this rule, as
well as in the CY 2022 PFS proposed rule (86 FR 39310 through 39311)
and CY 2022 PFS final rule (86 FR 65328), we have made permanent the
option for laboratories to maintain electronic documentation of miles
traveled for the purposes of covering the transportation and personnel
expenses for trained technicians to travel to the location of an
individual to collect a specimen sample. This option for laboratories
to maintain electronic documentation applies to specimen collection for
any CDLT. Laboratories should continue to utilize electronic and/or
other documentation in order to demonstrate miles traveled for the
purposes of specimen collection. We reiterate that laboratories will
need to be able to produce electronic documentation in a form and
manner that can be shared with MACs, and should continue to consult
with their local MACs regarding the format and process for submission
of this information if necessary. We believe that the electronic
documentation of miles traveled will continue to reduce administrative
burden for laboratories for the Medicare CLFS travel allowance for
specimen collection payment policy while also serving as evidence of
the miles traveled.
Comment: One commenter was concerned that having to track mileage
for travel and account for the number of Medicare beneficiaries from
whom specimens are collected would impose administrative burden on
laboratories seeking payment for the travel allowance.
Response: The commenter is correct that laboratories will be
required to track eligible miles for the travel allowance, as well
account for the Medicare beneficiaries from whom specimen are
collected. However, we believe that these activities are consistent
with typical administrative activities necessary to conduct business
and will not impose an undue burden upon laboratories. Furthermore, we
believe laboratories that currently provide these services are already
tracking this information. As described in above and in section
III.C.6.e. of this final rule, laboratories may now maintain electronic
documentation of miles traveled for the purposes of covering the
transportation and personnel expenses for trained personnel to travel
to the location of a Medicare beneficiary to collect a specimen sample.
Comment: We received several comments regarding our proposed travel
allowance mileage rate. Several commenters supported the usage of the
IRS standard mileage rate and the usage of the median hourly wage rate
for phlebotomists as published by the BLS. Several commenters also
supported using the factor of 40 to represent average miles-per-hour
driving speed.
Response: We believe that these components of the travel allowance
mileage rate appropriately align with the statutory requirement at
section 1833(h)(3)(B) of the Act that the travel allowance cover both
the ``transportation'' and ``personnel expenses'' for trained personnel
to travel to the location of an individual to collect a sample.
Comment: Several commenters stated that the travel allowance
mileage rate should incorporate more expenses than wages. The
commenters noted that the BLS wage rate definition indicates that the
wage rate is based on total earnings before payroll deductions,
excluding premium pay for overtime and for work on weekends and
holidays, shift differentials, and nonproduction bonuses such as lump-
sum payments provided in lieu of wage increases. Therefore, commenters
stated that CMS should consider including a component in the travel
allowance mileage rate that accounts for overhead and other associated
costs, such as taxes, contributions, and registration fees.
Response: We recognize that utilizing the BLS median wage rate for
a phlebotomist accounts for wages specifically related to the
phlebotomist and would not expressly account for overhead costs for
employing a phlebotomist. However, as we stated in the proposed rule,
we believe that utilizing the median wages for phlebotomists is a
reasonable proxy for estimating the personnel expenses related to CLFS
travel allowance for the range of professionals that could be employed
as the trained technician. As described above, we note that the term
``trained technician'' does not specify certain educational
requirements, and we believe that the types of professionals serving as
``trained technicians'' for the purposes of specimen collection could
include a variety of types of specialists with varying levels of
training, including a phlebotomist.
We believe that utilizing the wage amounts for a phlebotomist
provides a reasonable proxy for accounting for the personnel expenses
for the range of types of trained professionals traveling to the
location of a Medicare beneficiary to collect the sample. We continue
to believe that in this context, wages for a phlebotomist broadly
represent the general personnel costs for the types of professionals
serving as a trained technician and generally account for the trained
technician's time for traveling to collect the sample and serve as a
reasonable proxy for the personnel expense's component described in the
statute. Therefore, we are finalizing as proposed the travel allowance
mileage rate at Sec. 414.523(a)(2)(iii)(B) and we will update the
Medicare Claims Processing Manual, Chapter 16, section 60 guidance
accordingly.
Comment: One commenter requested that we further explain what we
mean by ``trained technician'' and that the wage rate we apply in the
travel allowance amount methodology reflect such description.
Response: As described above, section 1833(h)(3) of the Act refers
to staff providing specimen collection services as ``trained
personnel'' whereas the Medicare Claims Processing Manual, chapter 16,
section 60.2, refers to ``the technician.'' We note that the BLS
defines clinical laboratory technologists and technicians as workers
who collect samples and also perform tests to analyze body fluids,
tissue, and other substances, and, therefore, we believe that the
category of ``laboratory technician'' may not apply to those staff that
would generally be providing specimen collection services requiring
travel, as the staff collecting and transporting specimens may not also
be involved in analyzing the specimens. Therefore, for the purposes of
our Medicare payment policies for specimen collection and travel
allowance, we proposed to use the phrase ``trained technician'' to
refer to those staff providing specimen collection services and related
travel. We continue to believe this clarification would more closely
align the regulatory text concerning specimen collection and travel
allowance with the statute. We noted that the BLS defines a
phlebotomist as a professional who draws blood for tests, transfusions,
research, or blood donations.
Additionally, we clarify that the term ``trained technician'' does
not specify certain educational requirements, and we are not creating
qualification requirements for those individuals providing specimen
collection services to Medicare beneficiaries.
[[Page 69760]]
Comment: Several commenters expressed support for the proposed
travel allowance amount calculation. Commenters specifically
appreciated the clarification regarding the proration by the number of
beneficiaries for whom a specimen collection fee is paid.
Response: We continue to believe these changes and clarifications
will improve and simplify the administration of both the specimen
collection and travel allowance payment policies.
In consideration of public comments, we are finalizing the proposed
provisions for the laboratory specimen collection fee and travel
allowance at 42 CFR part 414, subpart G with refinements to the
description of eligible miles such that eligible miles begin at the
laboratory or the starting point of the technician's travel for
specimen collection and end at the laboratory or the ending point of
the technician's travel for specimen collection where the trained
technician returns the specimen(s) for testing.
We note that updates to the travel allowance mileage rate will be
issued through subregulatory guidance, specifically the existing CMS
change request process, on an annual basis. Updates will be made to the
travel allowance mileage rate based upon the most recently published
IRS standard mileage rate,\183\ as well as the most recently published
wage rate for phlebotomist as published by the BLS.\184\ The revised
travel allowance mileage rate will be effective for the January update
of the clinical laboratory fee schedule file. Additionally, we note
that we will make conforming changes to the Claims Processing Manual,
Chapter 16, section 60 to reflect the changes to the travel allowance
policies, including any changes and/or clarifications and will remove
sections of the manual containing policies that are no longer
applicable, consistent with the policies established in this final
rule.
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\183\ https://www.irs.gov/tax-professionals/standard-mileage-rates.
\184\ https://www.bls.gov/ooh/healthcare/phlebotomists.htm.
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D. Expansion of Coverage for Colorectal Cancer Screening and Reducing
Barriers
Medicare coverage for colorectal cancer (CRC) screening tests under
Part B are described in statutes (sections 1861(s)(2)(R), 1861(pp),
1862(a)(1)(H) and 1834(d) of the Act), regulation (42 CFR 410.37), and
National Coverage Determination (NCD) (Section 210.3 of the Medicare
National Coverage Determinations Manual). The statute and regulations
expressly authorize the Secretary to add other tests and procedures
(and modifications to tests and procedures) for colorectal cancer
screening with such frequency and payment limits as the Secretary finds
appropriate based on consultation with appropriate organizations.
(Section 1861(pp)(1)(D) of the Act; Sec. 410.37(a)(1)(v)). For a
number of CRC screening tests, the statute at section 1834(d) of the
Act established frequency and payment limits restricting coverage to
individuals at least 50 years of age. In the CY 2023 PFS proposed rule
(87 FR 45860), we proposed to expand Medicare coverage of certain CRC
screening tests by reducing the minimum age payment limitation to 45
years in our regulations at Sec. 410.37 and in NCD 210.3. As proposed,
the provision would align our coverage with a recently revised
recommendation by the United States Preventive Services Task Force
(USPSTF) for certain CRC tests as permitted by section 1834(n) of the
Act. Moreover, after consulting with appropriate organizations, we
proposed to modify the payment limitation for other CRC screening tests
identified in Sec. 410.37 and in NCD 210.3 to permit coverage for
individuals to begin at age 45.
In addition, we proposed to expand the regulatory definition of CRC
screening tests to include a follow-on screening colonoscopy after a
Medicare covered non-invasive stool-based CRC screening test returns a
positive result. We explained that historically, CMS has viewed a
colonoscopy after a positive non-invasive stool-based CRC screening
test to be a diagnostic colonoscopy. In recent years, the clinical
recommendations and guidance of medical professional societies and
screening experts have evolved for stool-based colorectal cancer
screening due to a number of factors including the relative number of
false positive results, low follow-up colonoscopy rates and patient
access barriers. For example, the positive predictive value of a FIT
(fecal immunochemical test) (the likelihood that an individual with a
positive FIT test result actually has colorectal cancer) reportedly
varies widely from 8 to 21 percent depending on the test and testing
center.\185\ Importantly, recent published evidence has again
highlighted that individuals who did not get a follow-up colonoscopy
were about twice as likely to die of colorectal cancer compared to
individuals who did have one.\186\ Since the overall goal of
programmatic cancer screening using any CRC screening test is to
prevent cancer, allow for early detection and treatment and reduce
cancer mortality, the follow-up colonoscopy is integral with non-
invasive stool-based CRC screening, since improvements in health
outcomes would not be possible without the follow-up. Medical
professional organizations and clinical experts have reached consensus
based on the evidence on this recommendation. In May 2021, USPSTF
revised their evidence-based recommendation to include the statement
``Positive results on stool-based screening tests require follow-up
colonoscopy for the screening benefits to be achieved.'' \187\
Accordingly, we proposed to modify CRC screening tests within our
authority in consultation with appropriate organizations. The outcome
of our more appropriate and complete approach to CRC screening will be
that, in many cases, beneficiary cost sharing for both the initial
screening stool-based test and the follow-on screening colonoscopy test
will not apply because both tests will be paid at 100 percent (no
applicable copayment percentage) as specified preventive screening
services under the statute. The issue of when the follow-on screening
colonoscopy involves the removal of tissue or other matter or other
procedure furnished in connection with, as a result of, and in the same
clinical encounter as the screening test will not change from current
policy. We noted in the proposed rule that we believe the new
understanding will encourage the wider utilization of non-invasive CRC
screening tests and reduce barriers to screening, prevention and early
detection of CRC.
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\185\ Nielson CM, Petrik AF, Jacob L, et al. Positive predictive
values of fecal immunochemical tests used in the STOP CRC pragmatic
trial. Cancer Med. 2018;7(9):4781-4790. doi:10.1002/cam4.1727.
\186\ Zorzi M, Battagello J, Selby K, et al. Non-compliance with
colonoscopy after a positive faecal immunochemical test doubles the
risk of dying from colorectal cancer. Gut. 2022;71(3):561-567.
doi:10.1136/gutjnl-2020-322192.
\187\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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As proposed, our policies would update Medicare coverage and
payment policies to align with our new understanding of CRC screening.
We noted that we believe the proposals would expand access to quality
care and improve health outcomes through prevention, early detection,
more effective treatment and reduced mortality. Moreover, we noted that
we believe they would directly advance health equity by promoting
access and removing barriers for much needed cancer prevention and
early detection within rural communities and
[[Page 69761]]
communities of color that are especially impacted by the incidence of
CRC.
We also discussed that the proposals directly supported President
Biden's Cancer Moonshot Goal to cut age-adjusted death rate from cancer
by at least 50 percent and addressed his recent Proclamation of March
as National Colorectal Cancer Awareness Month. As noted in the proposed
rule, the proclamation stated that ``early stages of colorectal cancer
often emerge without symptoms, and it is important to begin regular
screenings starting at the age of 45.'' It continued with ``Thanks to
the Affordable Care Act, most health insurance plans must cover certain
preventive services with no out-of-pocket costs. This coverage now
includes colorectal cancer screenings for adults over the age of 45,
making it easier to get colorectal cancer screenings and helping
improve access to earlier treatment.'' \188\
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\188\ https://www.whitehouse.gov/briefing-room/presidential-actions/2022/02/28/a-proclamation-on-national-colorectal-cancer-awareness-month-2022/.
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1. Background
In CY 2019, the last year for which incidence data are available,
CRC accounted for the 4th highest rate of new cancer cases and 4th
highest rate of cancer deaths in the United States.\189\ The National
Cancer Institute estimates that in 2021, 149,500 individuals will be
newly diagnosed with CRC and 52,980 individuals will die from CRC in
the United States.\190\ The Center for Disease Control and Prevention
(CDC) advises, ``Colorectal cancer almost always develops from
precancerous polyps (abnormal growths) in the colon or rectum.
Screening tests can find precancerous polyps, so that they can be
removed before they turn into cancer. Screening tests can also find
colorectal cancer early, when treatment works best . . . Regular
screening, beginning at age 45, is the key to preventing colorectal
cancer and finding it early.'' \191\
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\189\ https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/.
\190\ https://seer.cancer.gov/statfacts/html/colorect.html.
\191\ https://www.cdc.gov/cancer/colorectal/basic_info/screening/.
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Rural communities and communities of color are especially impacted
by the incidence of CRC. A CDC study found the death rate of CRC (per
100,000) to be 17.1 in rural nonmetropolitan counties verses 14.0 in
metropolitan counties with populations greater than 1 million.\192\
African Americans experience both new cases and deaths from colorectal
cancer at rates significantly above those of all races.\193\ An article
in the American Journal of Pathology states African Americans also are
often diagnosed at a younger age (median ages, 66 and 70 years for
African American men and women compared with 72 and 77 years for white
men and women, respectively). Moreover, African Americans are two times
more likely to be diagnosed with CRC before the age of 50 years, which
justified the recommendation to begin endoscopic screening at the age
of 45 years instead of 50 years.\194\
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\192\ Henley SJ, Anderson RN, Thomas CC, Massetti GM, Peaker B,
Richardson LC. Invasive Cancer Incidence, 2004-2013, and Deaths,
2006-2015, in Nonmetropolitan and Metropolitan Counties--United
States. MMWR Surveill Summ 2017;66(No. SS-14):1-13. DOI: http://dx.doi.org/10.15585/mmwr.ss6614a1.
\193\ https://seer.cancer.gov/statfacts/html/colorect.html.
\194\ Augustus GJ, Ellis NA. Colorectal Cancer Disparity in
African Americans: Risk Factors and Carcinogenic Mechanisms. Am J
Pathol. 2018;188(2):291-303. doi:10.1016/j.ajpath.2017.07.023.
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In May 2021, the USPSTF issued a revised Final Recommendation
Statement on CRC Screening. This replaced the prior USPSTF 2016 Final
Recommendation Statement and included a number of updated policy
recommendations based on new evidence and understandings of CRC and CRC
Screening. In terms of health disparities in CRC and CRC screening, the
May 2021 revised USPSTF statement reads, ``The causes for these health
disparities are complex; recent evidence points to inequities in the
access to and utilization and quality of colorectal cancer screening
and treatment as the primary driver for this health disparity rather
than genetic differences . . . Black adults across all age groups,
including those younger than 50 years, continue to have higher
incidence of and mortality from colorectal cancer than White adults.''
\195\
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\195\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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In addition to reducing the minimum age for Medicare payment for
CRC screening test payment, we proposed to address a longstanding
barrier and disincentive to CRC screening using a non-invasive stool-
based test as a first step of a complete screening. Examples of
Medicare covered non-invasive stool-based CRC screening tests include a
guaiac-based fecal-occult blood test (gFOBT) described in regulation at
Sec. 410.37(a)(2)(i) and in National Coverage Determination 210.3
Colorectal Cancer Screening Tests, as well as immunoassay-based fecal-
occult blood test (iFOBT) and the CologuardTM--Multitarget
Stool DNA (sDNA) test described in NCD 210.3. For the best health
outcomes from CRC prevention and early detection, it is important that
patients receive a complete CRC screening.
In recent years, government bodies and professional societies have
reconsidered their understanding of a complete CRC screening and now
consider CRC screening incomplete for individuals with a positive
result on a stool-based test until a follow-on screening colonoscopy is
also completed. The National Colorectal Cancer Roundtable recommends
that the patient should only be counted as having completed the CRC
screening process after a colonoscopy is performed.\196\ Under current
Medicare policies, if a Medicare patient initially receives a positive
result from a non-invasive and less burdensome screening stool-based
CRC test, the test would be viewed as showing signs or symptoms of
colorectal cancer. If a beneficiary received a subsequent colonoscopy,
we viewed the test as a diagnostic procedure and normal beneficiary
cost sharing rules for diagnostic test would apply. Our current policy,
however, may discourage patients from seeking a follow-on colonoscopy
because of the Medicare cost-sharing. A 2018 guideline update from the
American Cancer Society on CRC screening for average-risk adults reads
``Trials offering a choice between a stool test and a structural
examination compared with either test alone have generally demonstrated
greater uptake when a choice is offered. The best evidence in the
United States derives from a randomized trial in a safety-net
population comparing annual gFOBT versus colonoscopy versus choice
between the 2 in which it was demonstrated that choice was more
effective than offering colonoscopy alone. In the first year of the
study, which included patient navigation (year 1 only), the screening
completion rate was 38% for patients offered colonoscopy, 66 percent
for those offered gFOBT, and 68 percent for those offered a choice.
While uptake overall was similar in the gFOBT group versus the choice
group, it is clear that a ``colonoscopy-only'' referral resulted in
substantially lower adherence.'' \197\
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\196\ http://nccrt.org/wp-content/uploads/0305.60-Colorectal-Cancer-Manual_FULFILL.pdf.
\197\ https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21457.
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One of the goals of CRC screening is to enable the healthcare
system to identify patients who need treatment early enough to prevent
or treat the condition most effectively. In order to encourage patients
to obtain a follow-on
[[Page 69762]]
colonoscopy, a number of appropriate organizations have suggested that
we adopt a new approach that looks at colorectal cancer screening as a
continuum in the scenario where an initial stool-based test returns a
positive result and includes a follow-on screening colonoscopy, when
determined appropriate by the patient and the healthcare provider.
There currently exists a misalignment of applicable patient cost
sharing for a follow-on screening colonoscopy after a positive non-
invasive stool-based test as Medicare coverage policies have not yet
been updated to align to this new understanding of a complete CRC
screening described earlier. If the patient had chosen the more
expensive, invasive and burdensome screening colonoscopy as the first
step in their CRC screening, there would be no applicable beneficiary
cost sharing for the screening colonoscopy. However, under current
policy, if the patient initially receives a positive result from a non-
invasive, less burdensome and less expensive stool-based test as the
first step in their CRC screening, beneficiary cost sharing would not
be applicable for the initial stool-based test, but would be applicable
for the subsequent colonoscopy (because it would be considered a
diagnostic testing service given the presence of signs and symptoms of
disease based on the result of the initial stool-based test).
2. Statutory Authority
Section 1861(s)(2)(R) of the Act includes CRC screening tests in
the definition of medical and other health services that fall within
the scope of Medicare Part B benefits described in section 1832(a)(1)
of the Act. Section 1861(pp) of the Act defines ``colorectal cancer
screening tests'' and specifically names the following tests:
Screening fecal-occult blood test;
Screening flexible sigmoidoscopy; and
Screening colonoscopy.
Section 1861(pp)(1)(D) of the Act also authorizes the Secretary to
include in the definition of CRC screening tests other tests or
procedures and modifications to the tests and procedures described
under this subsection, with such frequency and payment limits as the
Secretary determines appropriate, in consultation with appropriate
organizations. Section 1834(d) of the Act describes limitations for
payment of CRC screening tests, including that no payment may be made
for CRC screening tests of screening fecal-occult blood test at section
1834(d)(1)(B)(i) of the Act and screening flexible sigmoidoscopy at
section 1834(d)(2)(E)(i) of the Act for patients under the age of 50.
Section 1834(d) of the Act does not describe a minimum age limit for
screening colonoscopy.
Section 1834(n) of the Act, added by section 4105 of the Affordable
Care Act, grants the Secretary the authority to modify coverage of
certain preventive services identified in section 1861(ddd)(3) of the
Act, which in turn cross-references section 1861(ww)(2) of the Act
(including CRC screening tests at section 1861(ww)(2)(E) of the Act).
The Secretary may modify coverage to the extent that such modification
is consistent with the recommendations of the USPSTF, per section
1834(n)(1)(A) of the Act.
3. Regulatory Authority
Our implementing regulations for CRC screening are codified at
Sec. 410.37. Similar to section 1834(d) of the Act, Sec. 410.37
describes limitations on coverage and provide that payment may not be
made for screening fecal-occult blood tests at Sec. 410.37(c) or
screening flexible sigmoidoscopies at Sec. 410.37(e) for individuals
under the age of 50. Also similar to section 1834(d) of the Act, Sec.
410.37(g) does not describe a minimum age requirement for screening
colonoscopies. Section 410.37 also establishes coverage for screening
barium enemas at paragraph (h) and limits coverage to and individual 50
years of age or greater for an individual who is not at high risk of
CRC at paragraph (h). Section 410.37(h) does not describe a minimum age
limit for coverage of screening barium enemas for individuals who are
at high risk of CRC.
4. National Coverage Determination
NCD 210.3 CRC Screening Tests was last revised effective January
19, 2021, when coverage was expanded to include Blood-based Biomarker
Tests. NCD 210.3 was previously revised effective October 9, 2014, when
coverage was expanded to include The CologuardTM--Multi-
target Stool DNA (sDNA) Test. Prior to that, NCD 210.3 was revised
effective January 1, 2004, when coverage was expanded to include
immunoassay-based fecal occult blood test (iFOBT), which can be used as
alternative to existing guaiac-based fecal occult blood test (gFOBT).
Under NCD 210.3, the Blood-based Biomarker Tests, sDNA test, iFOBT and
gFOBT tests all include a limitation of coverage that the patient be at
least 50 years of age.
In the NCD 210.3 Final Decision Memo dated January 19, 2021, we
noted that multiple commenters provided an alert that a draft USPSTF
revised CRC recommendation was circulating and which included a
recommendation that CRC screening begin at age 45 instead of 50. The
commenters on the draft NCD Decision Memo, in the course of the NCD
process, also encouraged CMS to align screening age limitations for all
CRC screening tests. At that time, the draft USPSTF recommendation had
not been finalized. Therefore, we responded that we are finalizing NCD
210.3 coverage of CRC screening tests with an age range of 50 to 85
years of age. That said, if the draft USPSTF recommendation is
finalized and/or other society guidelines are revised, we may
reconsider, in consultation with appropriate professional
organizations, the appropriate CRC screening tests limitations and
address appropriately in an efficient manner.
5. Revisions
In May 2021, the USPSTF issued a revised recommendation (with a
Grade B) that adults who do not have signs or symptoms of CRC and who
are at average risk for CRC begin screening at age 45 instead of the
previous recommendation of age 50.\198\ Accordingly, we proposed to
exercise our authority under section 1834(n) of the Act to modify
coverage of certain CRC screening tests to begin when the individual is
age 45 or older. The tests included in the May 2021 USPSTF revised
recommendation, including stool-based tests of gFOBT, iFOBT and sDNA,
and direct visualization test of flexible sigmoidoscopy. Screening
colonoscopy does not have a minimum age requirement under Medicare
coverage. We invited public comment on this proposal.
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\198\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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The following is a summary of the comments we received and our
responses.
Comment: Overall, commenters expressed support for our proposal to
exercise our authority under section 1834(n) of the Act modify coverage
of certain CRC screening tests described above and recommended by the
USPSTF to begin when the individual is age 45 instead of 50.
Response: We thank commenters for their support for our proposal to
exercise our authority under section 1834(n) of the Act modify coverage
of certain CRC screening tests described above and recommended by the
USPSTF to begin when the individual is age 45 instead of 50.
Comment: One commenter recommended that all CRC screening tests
should have no minimum age as a condition of coverage or payment,
[[Page 69763]]
similar to screening colonoscopy described earlier in our provision.
Response: We disagree with the commenter's recommendation that all
CRC screening tests should have no minimum age as a condition of
coverage or payment. Age limitations as conditions of coverage and
payment are a common and long-established safeguard in statute,
regulation and NCD, which protect beneficiaries from clinically
inappropriate services and protect beneficiaries and the Medicare
program from fraud, waste and abuse. The age limitations described in
our provision are in alignment with clinical evidence-based
recommendations by the USPSTF, American Cancer Society, and other
medical specialty societies.
After consideration of public comments, we are finalizing our
proposal made in the CY 2023 PFS proposed rule to exercise our
authority under section 1834(n) of the Act to modify coverage of
certain CRC screening tests described above and recommended by the
USPSTF to begin when the individual is age 45 instead of 50.
We also proposed to exercise our authority under section
1861(pp)(1)(D) of the Act to expand coverage of certain CRC screening
tests to begin for individuals at age 45 for barium enema test
(coverage described in Sec. 410.37(h)) and blood-based biomarker tests
(coverage described in NCD 210.3). We discussed in the proposed rule
that while these tests were not recommended in the earlier mentioned
May 2021 revised USPSTF recommendation, they are Medicare covered CRC
screening tests and would be an important alternative to the stool
based and direct visualization tests, especially for individuals with
medical complexity and those in rural and underserved communities. We
noted that aligning the minimum age requirements for certain Medicare
covered CRC screening tests described in our proposal to consistently
begin for individuals at age 45 would avoid confusion and reduce
barriers for beneficiaries and healthcare professionals. The proposal
reflected our belief that consistent coverage and payment policies
would be important in promoting CRC screening, which would result in
expanded prevention, early detection and improved health outcomes. As
proposed, conforming changes to reduce the minimum age for certain CRC
screening tests would be made at Sec. 410.37 and NCD 210.3 authorities
described earlier. We did not propose to modify existing conditions of
coverage or payment for maximum age limitations and frequency
limitations. We also retained the same existing frequency limitations
except in the instance of a follow-on screening colonoscopy after a
positive result from a non-invasive stool-based CRC screening test. We
proposed to amend Sec. 410.37 paragraph (c)(1), by removing the phrase
``under age 50'' and adding in its place the phrase ``under age 45'',
amend paragraph (c)(2), by removing the phrase ``individual 50 years of
age'' and adding in its place the phrase ``individual 45 years of
age'', amend paragraph (e)(1), by removing the phrase ``under age 50''
and adding in its place the phrase ``under age 45'', amend paragraph
(e)(2) by removing the phrase ``individual 50 years of age'' and adding
in its place the phrase ``individual 45 years of age'', and amend
paragraph (i)(1), by removing the phrase ``individual age 50'' and
adding in its place the phrase ``individual age 45''. We also proposed
to issue formal instructions that would revise the minimum age for the
CRC screening tests described in NCD 210.3 from 50 to 45 years.
As explained in the proposed rule, we consulted with and reviewed
recommendations from the following appropriate organizations in our
proposal to uniformly reduce the minimum age for certain CRC screening
tests from 50 to 45. ACS recommended that people of average risk of CRC
start regular screening at age 45 and recommends stool-based tests and
visual exam-based tests.\199\ The American Society of Colon and Rectal
Surgeons (ASCRS) recommended CRC screenings for individuals 45 years of
age and older and identifies barium enema as one of multiple screening
options.\200\ The U.S. Multi-Society Task Force on Colorectal Cancer,
which represents the American College of Gastroenterology, the American
Gastroenterological Association, and the American Society for
Gastrointestinal Endoscopy, recently revised their recommendation that
CRC screening for individuals of average risk of CRC begin at age 45
instead of 50.\201\ The Centers for Disease Control and Prevention
(CDC) website advised regular screening, beginning at age 45, as the
key to preventing colorectal cancer and finding it early. The CDC
website goes on to describe the earlier mentioned May 2021 revised
USPSTF recommendations.\202\
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\199\ https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html.
\200\ https://fascrs.org/patients/diseases-and-conditions/frequently-asked-questions-about-colorectal-cancer.
\201\ Gastroenterology. 2022 Jan;162(1):285-299. doi: 10.1053/
j.gastro.2021.10.007. Epub 2021 Nov 15.
\202\ https://www.cdc.gov/cancer/colorectal/basic_info/screening/.
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We considered the importance of aligning the minimum age
requirement for CRC screening across Medicare covered CRC screening
tests, as well as private health plans and Medicaid impacted by the May
2021 revised USPSTF recommendation. We noted that we believe consistent
policy across payers in terms of minimum age limits for CRC screening
tests is critical to the public's understanding of evolving CRC
screening recommendations. As added by section 2713 of the ACA, 42
U.S.C 300gg-13 requires a that group health plan and a health insurance
issuer offering group or individual health insurance coverage shall, at
a minimum, provide coverage for and shall not impose any cost sharing
requirements for evidence-based items or services that have in effect a
rating of ``A'' or ``B'' by the USPSTF. In addition, we considered that
section 1905(a)(13) of the Act, added by section 4106 of the ACA, which
expands Medicaid coverage to include screening services that are
assigned a grade of A or B by the USPSTF. We noted that expanding
coverage for barium enema and blood-based biomarker CRC screening tests
to a minimum age of 45, in alignment with the direct visualization and
stool-based tests recommended in the May 2021 revised USPSTF
recommendation, would allow additional, low burden options and
alternatives that may be preferred by some health professionals and
patients. While the recommendations from different professional
societies and other appropriate organizations include varying detail in
terms of specific tests, we noted that we understood the growing
consensus in the health care community is that the pathology of CRC now
requires that broad preventative screening should begin for individuals
at age 45 instead of 50. We also noted that reducing the minimum age
for the Medicare covered CRC screening tests barium enema test
(coverage described in Sec. 410.37(h)) and blood-based biomarker tests
(coverage described in NCD 210.3) from 50 to 45 years of age, in
addition to and in alignment with the direct visualization and stool-
based tests described in the 2021 USPSTF recommendation, is appropriate
and consistent with our purpose of early detection of colorectal cancer
described in Sec. 410.37(a)(1). We discussed that we received public
comment broadly supportive of reducing the minimum age for certain CRC
screening tests in
[[Page 69764]]
both the CY 2022 PFS final rule (86 FR 65179) and in the public
comments in response to our Proposed Decisions Memo for NCD 210.3
Screening for Colorectal Cancer--Blood-Based Biomarker Tests (Final
Decision Memo dated January 19, 2021). We noted that we look forward to
further consultation with the public and appropriate organizations
through the public comment period for this proposed rule. We invited
public comment on this proposal.
The following is a summary of the comments we received and our
responses on our above described proposal.
Comment: We received numerous public comments expressing approval
of our proposal to exercise our authority under section 1861(pp)(1)(D)
of the Act to expand coverage of certain CRC screening tests to begin
for individuals at age 45 for barium enema test (coverage described in
Sec. 410.37(h)) and blood-based biomarker tests (coverage described in
NCD 210.3). Commenters expressed agreement with our earlier expressed
belief that our proposal would avoid confusion and reduce barriers for
beneficiaries and healthcare professionals and that consistent coverage
and payment policies would be important in promoting CRC screening,
which would result in expanded prevention, early detection and improved
health outcomes.
Response: We thank commenters for supporting our proposal to
exercise our authority under section 1861(pp)(1)(D) of the Act to
expand coverage of certain CRC screening tests to begin for individuals
at age 45 for barium enema test (coverage described in Sec. 410.37(h))
and blood-based biomarker tests (coverage described in NCD 210.3).
Comment: Some commenters recommended that CMS remove barium enema
as a covered CRC screening test for all individuals because it is not
recommended by the USPSTF, specialty society guidelines and is rarely
performed in current times.
Response: The recommendation in this comment is out of scope for
our proposals made in the CY 2023 PFS proposed rule, but we will take
it into consideration for possible future rulemaking.
After consideration of public comments, we are finalizing our
proposal made in the CY 2023 PFS proposed rule to exercise our
authority under section 1861(pp)(1)(D) of the Act to expand coverage of
certain CRC screening tests to begin for individuals at age 45 for
barium enema test (coverage described in Sec. 410.37(h)) and blood-
based biomarker tests (coverage described in NCD 210.3).
We also proposed to exercise our authority under section
1861(pp)(1)(D) of the Act to expand coverage of CRC screening tests to
include a follow-on screening colonoscopy after a Medicare covered non-
invasive stool-based CRC screening test returns a positive result. In
this scenario, we explained that we now understand the follow-on
screening colonoscopy to be part of a continuum of a complete CRC
screening and not a separate diagnostic, therapeutic or other
procedure. Relatedly, we proposed that the frequency limitations
described for screening colonoscopy in Sec. 410.37(g) would not apply
in the instance of a follow-on screening colonoscopy test after a
positive result from a Medicare covered stool-based test. We proposed
to add new paragraph (k) to Sec. 410.37 to state that, effective
January 1, 2023, colorectal cancer screening tests include a follow-on
screening colonoscopy after a Medicare covered non-invasive stool-based
colorectal cancer screening test returns a positive result. We aimed to
avoid disruption to the existing conditions of coverage and payment for
CRC screening for this unique scenario and include text noting the
frequency limitations described for screening colonoscopy in paragraph
(g) of this section shall not apply in the instance of a follow-on
screening colonoscopy test described in this paragraph.
We acknowledged that under current Medicare policy, a colonoscopy
after a stool-based CRC screening test returns a positive result would
be subject to beneficiary cost sharing because it would be considered a
diagnostic, therapeutic or other non-screening procedure. We discussed
that Sec. 410.32(a) describes a diagnostic test as an instance when
the physician who furnishes a consultation or treats a beneficiary for
a specific medical problem and who uses the results in the management
of the beneficiary's specific medical problem. Under current policy, a
positive result from the CRC screening stool-based test would be a sign
of illness or disease and the subsequent colonoscopy would be for
treatment and management of that specific medical problem. We explained
that we now believe our current policy of CRC screening to not include
a follow-on screening colonoscopy after a stool-based test returns a
positive result is incomplete and not in full support of our definition
of CRC screening test at Sec. 410.37(a)(1) for the purpose of ``early
detection of colorectal cancer''.
As proposed, the provision to expand the definition of CRC
screening to include a follow-on screening colonoscopy after a stool-
based test returns a positive result would include implications for
beneficiary cost sharing. In many cases, beneficiary cost sharing
(coinsurance and deductible) will not be applicable for the stool-based
test nor the follow-on colonoscopy screening tests, as described at
section 1833(1)(W)(ii) of the Act, as added by section 4104(b) of the
Affordable Care Act. When the follow-on screening colonoscopy requires
additional procedures furnished in the same clinical encounter, the
phased-in Medicare payment percentages for colorectal cancer screening
services described in regulation at Sec. 410.152(l) and finalized in
the CY 2022 PFS final rule (86 FR 65177 through 65179) will apply. That
is, when the follow-on screening colonoscopy includes the removal of
tissue or other related services during the same clinical encounter the
beneficiary coinsurance would be reduced over time from 15 percent for
services furnished during CY 2023 through CY 2026 to 10 percent for
services furnished during CY 2027 through 2029 to zero percent
beginning in CY 2030 and thereafter.
Our goal is that the patient and their healthcare professional make
the most appropriate choice in CRC screening, which included
considerations of the risks, burdens and barriers presented with an
invasive screening colonoscopy in a clinical setting as their first
step. CRC screening presents a unique scenario where there are
significant differences between screening stool-based tests and
screening colonoscopy tests in terms of invasiveness and burdens to the
patient and healthcare system. We recognized there are several
advantages to choosing a non-invasive stool-based CRC screening test as
a first step compared to a screening colonoscopy, including relative
ease of administering the test and potentially reducing the experience
of unnecessary burdensome preparation and invasive procedures. We
discussed that it has been reported that a large proportion (46
percent) of screening colonoscopies found no polyps \203\ so optimizing
use of a non-invasive stool-based screening test as a first step (when
determined appropriate by the patient and their healthcare
professional) would benefit the patient and also the Medicare program.
In many instances, a
[[Page 69765]]
colonoscopy is not the most appropriate first step in colorectal cancer
screening and would represent an unnecessary burden and over-servicing
for both the patient and healthcare system. The May 2021 revised USPSTF
recommendation reads, ``stool-based screening requires persons to
collect samples directly from their feces, which may be unpleasant for
some, but the test is quick and noninvasive and can be done at home
(the sample is mailed to the laboratory for testing), and no bowel
preparation is needed to perform the screening test.'' \204\ The May
2021 revised USPSTF recommendation goes on to described that direct
visualization CRC screening tests such as screening colonoscopy and
screening flexible sigmoidoscopy must be performed in a clinical
setting rather than home and require bowel preparation prior to the
test. In addition, sedation or anesthesia is usually used during
screening colonoscopy and the patient requires additional recovery time
and assistance with transportation home.
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\203\ Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H,
Chejfec G. Use of colonoscopy to screen asymptomatic adults for
colorectal cancer. Veterans Affairs Cooperative Study Group 380. N
Engl J Med. 2000 Jul 20;343(3):162-8. doi: 10.1056/
NEJM200007203430301. Erratum in: N Engl J Med 2000 Oct
19;343(16):1204. PMID: 10900274.
\204\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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We discussed that we have heard from interested parties that CMS
should consider a complete CRC screening to include a follow-on
screening colonoscopy when a non-invasive stool-based test returns a
positive result. We noted that we consulted with and reviewed
recommendations from a number of professional societies in developing
the proposal, including supportive letters and communications with
representatives from American Gastroenterological Association, American
Cancer Society Cancer Action Network, and Fight Colorectal Cancer. The
proposal regarding a new understanding of a complete CRC screening
aligns with a policy recommendation from the National Colorectal Cancer
Roundtable, which was ``established by the American Cancer Society
(ACS) and the Centers for Disease Control and Prevention (CDC) in 1997,
is a national coalition of public organizations, private organizations,
voluntary organizations, and invited individuals.'' \205\ The proposal
also aligned to a 2018 CRC screening guideline update from the American
Cancer Society, which read ``Implementation of the screening options
included in this guideline is premised on the requirement that the
appropriate follow-up to a positive (noncolonoscopic) test is a timely
colonoscopy. The follow-up colonoscopy should not be considered a
``diagnostic'' colonoscopy but, rather, an integral part of the
screening process, which is not complete until the colonoscopy is
performed. The information provided to patients to facilitate a choice
among tests must include the importance of follow-up of a positive
(noncolonoscopic) test with colonoscopy. Repeating a positive stool-
based test to determine whether to proceed to colonoscopy is not an
appropriate screening strategy.'' \206\
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\205\ https://nccrt.org/about/.
\206\ https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21457.
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We also considered the May 2021 revised USPSTF recommendation,
which includes the statement ``When stool-based tests reveal abnormal
results, follow-up with colonoscopy is needed for further evaluation .
. . Positive results on stool-based screening tests require follow-up
colonoscopy for the screening benefits to be achieved.'' \207\ We also
note that the U.S. Departments of Labor, Health and Human Services
(HHS), and the Treasury issued a Frequently Asked Questions guidance on
January 10, 2022 that reads, ``A [non-grandfathered group health] plan
or [health insurance issuers offering non-grandfathered group or
individual health insurance coverage] must cover and may not impose
cost sharing with respect to a colonoscopy conducted after a positive
non-invasive stool-based screening test or direct visualization
screening test for colorectal cancer for individuals described in the
USPSTF recommendation. As stated in the May 18, 2021 USPSTF
recommendation, the follow-up colonoscopy is an integral part of the
preventive screening without which the screening would not be
complete.\208\ The follow-up colonoscopy after a positive non-invasive
stool-based screening test or direct visualization screening test is
therefore required to be covered without cost sharing in accordance
with the requirements of PHS Act section 2713 and its implementing
regulations.'' \209\
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\207\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
\208\ The quoted text from the January 10, 2022 Frequently Asked
Questions guidance includes a footnote to this portion of the text
that reads, ``In addition, in its `Supporting Evidence' section, the
USPSTF Full Recommendation Statement states: `Several comments
requested that colonoscopy to follow up an abnormal noncolonoscopy
screening test result be considered part of screening. The USPSTF
recognizes that the benefits of screening can only be fully achieved
when follow-up of abnormal screening test results is performed. The
USPSTF added language to the Practice Considerations section to
clarify this.' ''
\209\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf.
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We believe that the proposal to update our regulations to align to
our new understanding of a complete CRC screening would address the
beneficiary cost sharing barrier that currently exists for most
individuals for a subsequent colonoscopy after an initial stool-based
test returns a positive result, would allow more options for healthcare
professionals and patients, would help optimize non-invasive CRC
screening test use, and improve health outcomes for Medicare
beneficiaries. We received public comments supportive of the policy
described in our proposal in both the CY 2022 PFS final rule (86 FR
65179) and in public comments to our Proposed Decision Memo for the NCD
210.3 Screening for Colorectal Cancer--Blood-Based Biomarker Tests
(Final Decision Memo dated January 19, 2021).\210\ We noted that we
look forward to further consultation with the public and appropriate
organizations through the public comment period for this proposed rule.
We invited public comment on the proposal.
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\210\ https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=299.
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The following is a summary of the comments we received and our
responses on our earlier described proposal.
Comment: Overall, commenters expressed support for our proposal to
exercise our authority under section 1861(pp)(1)(D) of the Act to
expand coverage of CRC screening tests to include a follow-on screening
colonoscopy after a Medicare covered non-invasive stool-based CRC
screening test returns a positive result. Many commenters expressed
agreement with our approach of a complete colorectal cancer screening
that includes a follow-on screening colonoscopy along with a stool-
based test (with a positive result). In addition, many commenters
expressed agreement with our statement that beneficiary cost sharing
for a follow-on colonoscopy after a stool-based test returns a positive
result is a burdensome and significant barrier to expanding screening
for colorectal cancer and, by extension, achieving better health
outcomes through prevention, early detection, improved treatment and
reduced mortality.
Response: We thank commenters for their support for our proposal to
exercise our authority under section 1861(pp)(1)(D) of the Act to
expand coverage of CRC screening tests to include a follow-on screening
colonoscopy after a Medicare covered non-invasive stool-based CRC
screening test returns a positive result.
[[Page 69766]]
Comment: Many commenters asked that we exercise our authority under
section 1861(pp)(1)(D) of the Act to further expand our approach of a
complete colorectal cancer screening. Many requested that we remove the
text ``stool-based'' from our proposed regulatory text at Sec.
410.37(k), resulting in a complete CRC screening including a follow-on
screening colonoscopy after a Medicare covered non-invasive screening
test. Many commenters requested that a complete CRC screening include a
screening colonoscopy after a positive result from a blood-based
biomarker test, as well as a stool-based test. A few requested that we
include a follow-on screening colonoscopy after any non-colonoscopy CRC
screening test. Many commenters cited our earlier reasoning of
consistency of policies across CRC screening tests to promote CRC
screening and avoid confusion among healthcare professionals and
beneficiaries in support their request for an expanded definition of a
complete colorectal cancer screening.
Response: We disagree with the commenters that requested a further
expansion of a complete colorectal cancer screening that would include
additional first step tests beyond a non-invasive stool-based test. We
believe the stool-based tests are unique to other CRC screening tests
in terms of their non-invasiveness, the fact that stool-based tests can
be implemented by the patient at home and mailed into the lab, the
absence of bowel preparation and anesthesia and the comparatively
lighter burden and mitigated potential for over servicing of the
patient and the healthcare system.
We agree that blood-based biomarker CRC screening tests have
significant potential and we expanded coverage to include them in the
reconsidered NCD 210.3, effective January 2021. We also recognize that
blood-based biomarker CRC screening tests continue to be an emerging
and quickly evolving technology. As of September 2022, no blood-based
biomarker tests have achieved the sensitivity and specificity
requirements of NCD 210.3. We also note that, as of September 2022,
blood-based biomarker screening tests are not recommended by the USPSTF
for CRC screening. The May 2021 USPSTF revised recommendation statement
reads, ``Because of limited available evidence, the USPSTF
recommendation does not include serum tests, urine tests, or capsule
endoscopy for colorectal cancer screening.'' \211\ The public comments
have been informative and we will consider this feedback for future
rulemaking.
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\211\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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Comment: A few commenters expressed concern that the narrative of
our proposal inappropriately favors stool-based tests over
colonoscopies and could discourage the use of colonoscopy as a first-
line CRC screening test in the Medicare population.
Response: We clarify that our provision for a complete colorectal
cancer screening does not change the coverage or payment requirements
for screening colonoscopy as an optional first step in the patient
screening process. We note that our proposal included the narrative,
``our goal is that the patient and their healthcare professional make
the most appropriate choice in CRC screening, which includes
considerations of the risks, burdens and barriers presented with an
invasive screening colonoscopy in a clinical setting as their first
step.''
After consideration of public comments, we are finalizing our
proposal made in the CY 2023 PFS proposed rule to exercise our
authority under section 1861(pp)(1)(D) of the Act to expand coverage of
CRC screening tests to include a follow-on screening colonoscopy after
a Medicare covered non-invasive stool-based CRC screening test returns
a positive result.
The scope of the proposals is limited to CRC screening tests and
does not address the coverage or payment status of other screening
services or tests recommended by the USPSTF or covered by Medicare.
The following is a summary of the comments we received and our
responses on our proposal as a whole.
Comment: Many commenters requested that CMS provide specific coding
instructions and educational materials for the Medicare Administrative
Contractors (MACs), healthcare systems, providers and beneficiaries to
inform them of the significant changes in Medicare policy on CRC
screening coverage and payment.
Response: We thank the commenters for the feedback and agree on the
importance of implementation and educating stakeholders. We will
provide implementation instructions, including coding and payment,
through the CMS Transmittals online platform \212\ and educational
articles through the Medicare Learning Network online platform.\213\
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\212\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals.
\213\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo.
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Comment: We received several comments that were outside of the
scope of the proposals made in the CY 2023 PFS proposed rule. Comments
included requests that CMS end its national policy of non-coverage of
Computed Tomography Colonography (CTC) for CRC screening (NCD 210.3),
requests that CMS extend our approach of a complete colorectal cancer
screening to breast, cervical, and lung cancer screenings,
recommendations on coverage of anesthesia services furnished by
anesthesia providers, and requests regarding the furnishing of
colonoscopies by Physicians Assistants and Nurse Practitioners.
Response: Although we are not summarizing and responding to these
comments in the final rule, we will take them into consideration for
possible future rulemaking.
After considering public comments, we are finalizing the proposals
made in the CY 2023 PFS proposed rule to expand coverage for CRC
screening and reduce barriers to access to CRC cancer prevention, early
detections and improved health outcomes.
6. Summary
In summary, we are exercising our authority in sections 1834(n) and
1861(pp)(1)(D) of the Act to expand CRC screening coverage by reducing
the minimum age for CRC screening tests from 50 to 45 years of age for
certain Medicare covered CRC screening tests that currently include a
minimum age of 50 as a limitation of payment or coverage. As finalized,
a screening colonoscopy would continue to not have a minimum age
limitation.
We also are exercising our authority in section 1861(pp)(1)(D) of
the Act to expand coverage of CRC screening tests to include a follow-
on screening colonoscopy after a non-invasive stool-based test returns
a positive result. As noted earlier in the rule, the outcome of our
more appropriate and complete approach to CRC screening will be that,
in many cases, beneficiary cost sharing for both the initial non-
invasive screening stool-based test and the follow-on screening
colonoscopy test will not apply because both tests will paid at 100
percent (no applicable copayment percentage) as specified preventive
screening services under the statute.
We believe the proposals will expand access to quality care and
improve
[[Page 69767]]
health outcomes for patients through prevention, early detection, more
effective treatment and reduced mortality. Our policies to expand
coverage of CRC screening tests will directly advance the Biden
Administration's health equity goals. Rural communities and communities
of color are especially impacted by the incidence of CRC. African
Americans experience both new cases and deaths from colorectal cancer
at rates significantly above those of all races. As noted earlier in
the rule, the May 2021 revised USPSTF final recommendation statement
reads, ``The causes for these health disparities are complex; recent
evidence points to inequities in the access to and utilization and
quality of colorectal cancer screening and treatment as the primary
driver for this health disparity rather than genetic differences . . .
Black adults across all age groups, including those younger than 50
years, continue to have higher incidence of and mortality from
colorectal cancer than White adults.'' \214\ We believe our policies to
expand coverage of CRC screening will make significant progress in
reducing barriers and addressing this inequity in healthcare.
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\214\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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E. Removal of Selected National Coverage Determinations
As discussed in the CY 2023 PFS proposed rule (87 FR 45860) on
pages 46086 and 4087, we periodically identify and propose to remove
National Coverage Determinations (NCDs) that no longer contain
clinically pertinent and current information, in other words those
items and services that no longer reflect current medical practice, or
that involve items and services that are used infrequently by
beneficiaries. In the proposed rule we explained that since the CY 2021
PFS final rule (85 FR 84472), we have used notice and comment
rulemaking to obtain public comment on removing outdated NCDs,
replacing the prior subregulatory administrative process used on two
occasions in 2013 and 2015. Eliminating an NCD for items and services
means that the item or service will no longer be automatically,
nationally covered or non-covered by Medicare (42 CFR 405.1060).
Instead, the initial coverage determinations for those items and
services will be made by local Medicare Administrative Contractors
(MACs). We summarized the policy and explained the factors that we
consider.
In addition to the six factors listed below, we also consider the
general age of an NCD, changes in medical practice/standard of care,
the pace of medical technology development since the last
determination, and availability and quality of clinical evidence and
information to support removal of an NCD. We would consider proposing
the removal of an NCD if any of the following factors are present:
We believe that allowing local contractor discretion to
make a coverage decision better serves the needs of the Medicare
program and its beneficiaries.
The technology is generally acknowledged to be obsolete
and is no longer marketed.
In the case of a noncoverage NCD based on the experimental
status of an item or service, the item or service in the NCD is no
longer considered experimental.
The NCD has been superseded by subsequent Medicare policy.